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Final LCDs from MACS Lead To Questions on Coverage for Certain MIGS Procedures for Glaucoma Treatment
Hologic Reports Solid 3Q23; Mammography Backlog Driving Strong Capital Equipment Sales
SBRT Data Presented at ASTRO Shows High Efficacy in Localized Kidney Cancer; Could Become First Line Treatment if it Demonstrates Superiority Versus Surgery
Owlet Receives FDA Approval For Non-Prescription Dream Sock Significantly Expanding Market
Neuronetics Announces Positive Payer Coverage Changes for NeuroStar Depression Treatment Technology Eliminating Barriers to Adoption
Enovis Reports Strong 3Q23 and Raises Full Year Outlook Based Upon Strong Hip/Knee Growth; Expects to Drive Synergies Accelerate Growth With LimaCorporate Deal
GE Healthcare and Masimo Partner to Add Oxygen Saturation Measurement to the Portrait Mobile Wearable Monitoring Technology for Hospitals
New AABB Guidelines Recommend More Restrictive Guidelines on Red Blood Cell Transfusion
The Robots are Coming; Johnson & Johnson Plans to Start Surgical Trials on OTTAVA in 2024
Zimmer Sees Similar Trend Line to Peers With Elective Procedures Slowing From Early 2023; New CEO Focused on Innovation
SI-BONE Reports Strong Growth in 3Q23 Driven by Increased Physician Adoption and Procedure Expansion
Empatica Receives FDA Approval for Two New Biomarkers on Wearable to Support Clinical Research
Medicare Creates New $15 Billion Market for Previously Non-Reimbursed Exoskeleton Technologies; Microcap Companies Ekso Bionics and ReWalk Robotics Could Be the Biggest Beneficiaries
Cerus Reports Solid 3Q23 With Meaningful Progress Towards Cash Flow Breakeven; Pending Catalysts With IFC and Red Cell Technology Provide Exciting 2024 Set-Up
Endologix Shares Pooled Analysis at VIVA Showing Novel DETOUR System Results in Positive Outcomes for Severe PAD Patients With Less-Invasive Technique
CooperCompanies Announces Streamlined Acquisition of Cook Medical Reproductive Health Assets Following FTC Intervention; Despite Smaller Scale Deal to Be Highly Accretive in 2024
Gynesonics Raises $67.2 Million to Further Commercialize Innovative Uterine Fibroid Device; Follows Rash of Positive Coverage Decisions for the Technology
InspireMD Shows Positive Data at VIVA with CGuard Carotid Stent System Demonstrating Low Rate of DSMI at 30 Days Compared to Previous Studies
Beyond Air Study Using UNO Therapy in First Patients Shows Immunostimulatory Response and Low Side Effects; Warrants Further Investigation/Data
Smith + Nephew Focuses on Robotic Tool Expansion in Orthopedics/Trauma; Notes Some Elective Procedure Slowing Following the Post COVID-19 Catch Up
Haemonetics Beats in the Quarter; Plasma Catchup from Pandemic and Strong Hospital Growth Continue to Drive Results
Insulet Delivers Strong 3Q23 Based Upon Omnipod 5 Success; Product Cycle Momentum Shows No Signs of Slowing With Provider Adds, International Launch, and Type 2 Diabetes Expansion Primed for 2024
Increased Barostim Reimbursement in the HOPPS Causes CVRx Stock to Rally
Baxter Announces Largely In-Line 3Q22; Streamlining Portfolio to Focus on Growth With Divestiture of BioPharma Solutions and Planned Spin-Off of Kidney Care
AtriCure Reports Solid Growth in 3Q23 on the Heels of New Technology Offerings for Atrial Fibrillation
Stryker Management Very Bullish on Procedures and Capital Purchases Heading into FY24; Likely Right in Short-Term, but Broader Industry Trends Support Caution
What Stryker and Smith & Nephew Implant Growth Can Tell Us About Elective Procedure Trends; Consistent With Earlier HCA Data
Tandem Diabetes Care Disappoints in 3Q23 as it Pivots to Mobi and New Offerings in 2024
Nevro Corp. Beats Outlook and Raises Forecast but Faces Expanding Competition in High Growth Diabetic Neuropathy Indication
McKesson Beats in 3Q23, GLP-1 Drives Increased Pharma Segment Revenue and Increased Prescription Technology Solutions Due to Prior Authorization Service Demand
Macro Headwinds to Elective Procedures and Declining Profitability Weigh on STAAR in 3Q23
Glaukos Reports Solild 3Q23 but Commentary on Physician Behavior Due to Draft MIGS LCDs Weighs on Stock
Inari Medical Reports Solid 3Q23 and Announces Complementary LimFlow Acquisition, but Investors Worry About Dilution and Distraction from Core Market
ZimVie’s 3Q23 Better than Tepid Expectations, but Elective Procedure Headwinds in Dental Likely to Worsen and U.S. Spine Competition Unlikely to Abate
Penumbra Presents Interim Data From STRIKE-PE Study at VIVA Showing the Indigo Aspiration System Led to Positive Outcomes for Pulmonary Embolism Patients
Xēnix Medical Receives FDA Clearance for Innovative SOLACE Sacroiliac Fixation System Using Proprietary NANOACTIV Surface Technology
YourBio’s TAP Micro Receives CE Marking Joining Tasso+ As Cleared Technologies for Self Blood Collection; Cost and Volume Challenges Remain for Broadscale Adoption
What Hospital Capital Equipment Challenges? GE Healthcare Maintains Full Year Growth Outlook
MIMEDX Reports Strong 3Q23; With Skin Substitute LCDs in Rear View and EPIEFFECT Launch Company Well Positioned in Fourth Quarter
Pulmonx Corporation Reports Strong 3Q23 and Increases Full Year Outlook With Japan Launch and AeriSeal Study Pending
Movano Health’s Prototype Chip for Evie Ring Achieves FDA-Recognized Accuracy in Blood Pressure Monitoring Study
Surmodics Launches New Preside™ Medical Device Coating Technology
Zynex Announces Strategic Alternative Process Aimed at Driving Shareholder Value
New Study from Implicity Demonstrates The Ability of New Proprietary Algorithm to Reduce Alert Burden During Patient Monitoring for Atrial Fibrillation
Zynex Appears Poised for Momentum Following Sales Force Expansion and New Product Launches
Novocure Reports Slight 3Q23 Revenue Miss; Focus on Regulatory Submissions Following Successful LUNAR Trial
ResMed Delivers In-Line 3Q23; Highlights Opportunities in Digital Solutions and New Markets for Forward Growth
Ekso Bionics Shows Solid Progress in 3Q23; New CMS Reimbursement Change Could be Game Changer in 2024
Merit Reports Strong 3Q23 and Raises Full Year Outlook; Notes CEO Succession Plan Likely to be Announced by Year End
Apple Facing Potential Import Ban for Apple Watch Based Upon IP Challenges to Health Features From AliveCor and Masimo
Exactech Receives Approval for New 3D-Printed Tibial Implants for Small But Fast Growing Ankle Arthroplasty Market
Edwards Lifesciences’ TRISCEND II and CLASP IID Trials at TCT Enhance Company’s Position in Transcatheter Heart Valve Regurgitation and Set the Stage for EVOQUE approval in the U.S.
Dexcom Follows Abbott’s Footsteps With Exceptionally Strong 3Q23 in CGM; Medicare Expansion in Type 2 Diabetes and G7 Seem Like Early Innings of Substantial Product Cycle
Tissue Products Recall and Facility Closure Weigh on Integra LifeSciences 3Q23 Results; Expected to Be Resolved in Mid-2024
Outsource Device Manufacturer Integer Holdings Corporation Reports Strong 3Q23 and Guide; Positive Leading Indicator for Industry Cardiology and Neuromodulation Markets
Boston Scientific Reports Solid 3Q23 on Strong Cardiology Revenue; New Approvals, Acquisitions, and Data Sets Position the Company for Solid Growth Ahead
Surgical Products Provider CONMED Delivers Solid Performance Despite Allograft Supply Disruption
Inspira Technologies Receives Key Priming Patent Supporting the INSPIRA ART500 Respiratory Support Device
Edwards Lifesciences Reports In-Line 3Q23 But Guides Below Street for 4Q23 Following Strong Data Showing at TCT
Abbott’s Espirit BTK System Outperforms Angioplasty in PAD Patients With Chronic Limb-Threatening Ischemia
Positive Data for Boston Scientific’s Drug Coated Balloon Presented at TCT Could Support FDA Approval for In-Stent Restenosis
Abbott Presents Positive New Data at TCT on Transcatheter Devices for Tricuspid and Mitral Valve Regurgitation
Fresenius Medical Care Recalls Hemodialysis Machines Due to Potential Exposure to Toxic Compounds
Xtant Medical Buys Production Operations for nanOss Products from RTI Surgical Following Product Acquisition
Medtronic Evolut Trial Combined With Partner 3 Data May Be Nail in Coffin for Surgical Aortic Valves; Data Shows Lower Mortality With TAVR
Partner 3 Study Showing Long-Term Safety Profile of Transcatheter Aortic Valves Could Lead to Even Further Adoption Over Surgery
Globus Medical Presents Data From Long-Term Nuvasive Simplify Disc Study Demonstrating Superiority to Anterior Cervical Discectomy Fusion Procedures
Boston Scientific Reports Results From Electronic Health Record Study Showing EKOS Has Lower Adverse Event Rate Compared to Inari’s FlowTriever System
HCA Earnings Shows Some Softening in Surgical Volumes From Start of Year
ABK Biomedical Commences Pivotal Study in Hepatocelluar Cancer with First Patient Treated Using Microsphere Technology
Allergan Aesthetics Reports Positive Phase 3 Trial Results for New Fast Acting Neurotoxin for Face Wrinkles
Butterfly Network Signs Ultrasound Chip Deal With Forest Neurotech to Support Brain Measurement/Modulation Implantable Device
Elekta to Acquire Xoft, a Subsidiary of iCAD, Inc.; Allows iCAD to Focus on Core Imaging Software Business
Medtronic’s New Aurora EV-ICD Receives FDA Approval; Real World Performance Study Hopes to Show Lower Rates of Venous Complications
Wearable Ring Maker ŌURA Announces Canadian Retail Launch in Partnership with Best Buy
Insulet Corporation Achieves FDA Clearance for Omnipod 5 App for iPhone
CARMAT Reports Seven Aeson Implants Completed in EFICAS Clinical Trial for Its Total Artificial Heart Following Emergency Financing
Olympus Launches Next Generation Endoscopy System
OrthoPediatrics Launches Pediatric Nailing Platform for Tibial Fractures
Intuitive Surgical’s 3Q23 Shows Some Cracks in Capital Equipment Outlook; Procedure Growth Outlook Shows Signs of Softening
Protembis Gets FDA Approval for Cerebral Protection Device IDE; Study Design Could Show Superiority to Boston Scientific’s Sentinel Device
GE HealthCare and Novo Nordisk Join Forces to Advance Peripheral Focused Ultrasound Treatment for Diabetes Care
Edwards Life Sciences Announces CE Mark of First Transcatheter Tricuspid Valve; TRISCEND II Data Expected in June 2024 and U.S. Approval by End of 2024
Apollo Neuro Launches First Wearable With Subscription Service to Address Sleep Disturbance and Reduce Stress
AVITA Pre-Announces Accelerating Growth in 3Q23 and Secures $90M Debt Facility Following Recent Expanded Indications for RECELL and RECELL GO Filing Delay
NeuroPace Unveils RNS System Enhancements to Improve Care for Epilepsy Patients
Abbott Reports Strong Third-Quarter 2023 Results With Medical Device Sales up 15% Organically, Diagnostics up 6% Excluding COVID-19
Henry Schein Completes Acquisition of Shield Medical Expanding Home Care Offering
Sight Sciences Announces Strategic Cost Measures as it Awaits Final LCDs on MIGS Technology
JNJ Reports Strong 3Q23 Results But Global Med-Tech Sales Deaccelerate; Read Throughs for Other Companies
Fisher & Paykel Healthcare Launch New F&P Solo Mask for Sleep Apnea
Alphatec Showcases New Technology Offerings at NASS Meeting
Johnson & Johnson Receives FDA Approval for New Foot/Ankle Plating System
FDA Approves Establishment Labs Tissue Expander Technology for Mastectomy Patients
Henry Schein Cybersecurity Incident Disrupts Business Operations; Emblematic of Increased Risks Around Data Security
Data from Neuronetic’s NeuroStar Outcomes Registry Shows Significant Improvements in Remission/Response for Patients That Complete Full Therapy Course
Novocure Presents Data on Patient Tolerability/Quality of Life Data for NSCLC at ESMO from LUNAR Trial
GE Healthcare Announces FDA Approval for Allia IGS Pulse for Cardiac Imaging Procedures
Baxter Launches New Software Application Allowing the Capture of Eye Images on a Smart Phone During Opthalmoscope Procedures
Alphatec Holdings Preliminary 3Q23 Revenue; Strong Beat Driven by Continued Adoption of Lateral Access Techniques Leads to Full-Year Guidance Raise
COSMOS Study Demonstrates Ability of GE HealthCare’s Portrait Mobile Continuous Monitoring Solutions to Reduce Alarm Fatigue in Ward Environments
Sight Sciences Announces Results in SAHARA Clinical Trial Comparing TearCare vs. Standard of Care Restasis for Dry Eye Disease
FDA Approves New Oxygenation Parameter for Masimo Pulse Oximetry Platform
Medacta Study in Shoulder Arthroplasty Further Demonstrates the Potential of Augmented Reality in Orthopedics
Establishment Labs Presents Clinical Data On Mia Femtech, Minimally Invasive Breast Augmentation Technology; Launches New RFID Sensor
Tough Few Months for Dialysis Company Outset Following FDA Warning Letter, Novo Nordisk GLP-1 Data, and Now Pre-Released Revenue Miss
Getinge Acquires Healthmark Industries Strengthening Global Position in Sterile Reprocessing Market
DaVita Releases Statement Following Stock Sell-Off on Novo Nordisk’s GLP-1 Study Announcement
GE HealthCare Signs $44 Million Contract with BARDA to Develop AI-Enhanced POCUS Technology for Mass Casualty Events
Orthofix Medical Inc. Launches OsteoCove™ Synthetic Bone Graft
Braun Launches New Introcan Safety® 2 IV Catheter to Prevent Needlestick Injuries and Blood Exposure
Boston Scientific’s Neuromodulation System Receive FDA Approval for Treating Diabetic Peripheral Neuropathy; Joins Nevro, Medtronic, and Abbott in Increasingly Crowded Market
Pulmonx Announces CFO Transition; Pre-Releases Above Consensus Revenue for 3Q23
Masimo Gets CE Mark for New Hemodynamic Monitoring Module; Facilitates Access to Real Time Data on a Single Display
OrthoPediatrics Launches New Functional Brace for Pediatric Femur Fracture; Data Shows Cost Benefits, Ability to Prevent General Anesthesia
GE Healthcare and SOFIE Biosciences Partner on FAP Radiopharmaceuticals Shown to Be Highly Prognostic in Cancer Studies
Allurion Completes AUDACITY Trial Enrollment for Highly Non-Invasive Weight Loss Balloon
Silk Road Medical Pre-Announces Significant Revenue Miss; CEO Retirement
Teleflex Completes the Acquisition of Acquisition of Palette Life Sciences
FDA Issues Warning Letter to JNJ Subsidiary Abiomed Citing Issues with Impella Heart Pump
AdvaMed Announces New Digital Health Tech Division
Endotronix Announces New IDE for Class II Heart Failure Patients and Positive Early Data in PROACTIVE-HF Study for Class III Patients
Hologic Partners With AAGL and Inovus to Provide Training Solutions to New OB-GYNs
Alcon Introduces TOTAL30 Multifocal Contact Lenses to Address Presbyopia
Haemonetics Corporation to Acquire OpSens, Inc., Signals Further Move into Interventional Cardiology
Butterfly Network Introduces New Education Support Tools
Best Buy to Sell Dexcom G7 CGM System Online
Mindray Launches New Lightweight Wireless Ultrasound at ACEP
Multicenter Study Using Sonex Health Technology Cites Benefits of Ultrasound-Guided Carpal Tunnel Release
GE Healthcare Integrates Caption Guidance Heart Failure AI Technology Into Ultrasound Solutions
GE Healthcare and University Hospitals Sign 10-Year Strategic Partnership
Fresenius Kabi Receives Warning Letter from FDA on Fenwal Blood Products
Next-Generation Dexcom G7 Continuous Glucose Monitoring System Now Available in Canada
Accuray’s Tomo® C Radiation Treatment Delivery System Approved by China’s NMPA
AirLife Completes Acquisition of Avanos Medical’s Respiratory Health Business
Vapotherm Study Utilizes Computational Fluid Dynamics to Demonstrate High Velocity Therapy Leads to Better Clearance of CO2 from the Airway
Butterfly Network and Razom Partner to Expand Access to Butterly iQ+ Ultrasound Technology in Ukraine
Nanox Partners with Varex Imaging on New Manufacturing and Supply Agreement
Biotricity Announces Key Patent Filing for Biotres Electrocardiogram (ECG) Wearable Device
Sight Sciences Announces Significant Head-to-Head Study on MIGS Technologies for Glaucoma Patients
Avita Medical Announces FDA Request for Additional Information on RECELL GO; Timeline for Approval Moves To Mid-2024
Anumana Receives FDA 510k Approval for New AI Powered Heart Failure Diagnosis Technology
Cordis Completes Acquisition of MedAlliance in Deal Worth up to $1.135 Billion; SELUTION DeNovo Trial Could Have Big Implications for PCI Market
Following Lobbying by Radiologist Societies, CMS Allows for Billing of Multiple Cardiac MRI Procedures
Dexcom Presents Long-Term Data from the COMISAIR Study at EASD Demonstrating Positive Outcomes for Diabetes Patients Using CGM
Accuray Introduces Cenos™ Online Adaptive Therapy Option at ASTRO 2023
Carlyle Group Rumored To Be in Negotiations to Buy Medtronic’s Patient Monitoring and Respiratory Business Units
Siemens Healthineers Unveil New 3-D Mammography System with High-Speed Imaging Technology
Organogenesis Applauds Decision to Withdraw Medicare Local Coverage Determinations; Decision Eliminates Reimbursement Uncertainty for Company’s Wound Care Products
Nyxoah Partners with ResMed Germany to Advance Obstructive Sleep Apnea (OSA) Awareness and Therapy
Nanox.AI’s HealthCCSng Reveals Hidden Cardiovascular Risks in Routine CT Scans
Galen Robotics Receives First FDA Approval for Robotic ENT Surgical Robot; Announces Series B Funding Round
GN Hearing and Beltone Announce Launches of Next Generation Hearing Aids
4WEB Medical Expands Orthopedic Implant Portfolio with New FDA Approval; Moves Closer to Comprehensive Cervical Solution
Beacon Receives FDA Approval for Dreem 3S; Facilitates Collection of High Quality Sleep Data in the Home Setting
Boston Scientific To Acquire Relievant Medsystems for $850 Million; Gains Access to Lower Back Pain Technology
Cardinal Health Launches Kangaroo OMNI™ Enteral Feeding Pump
Dexcom Canada and RxFood Partner to Improve Diabetes Management; RxFood App Shown To Improve Diabetes Outcomes in Clinical Studies
Exo Unveils New Handheld Ultrasound Device for Point-of-Care Imaging
iRhythm Unveils Next Generation Zio Monitor and Long-Term Continuous Monitoring Service
FDA Issues Final Guidance Document on Cybersecurity Requirements for Premarket Device Submissions
Changes for Exoskeleton Reimbursement Under Home Health Prospective Payment System Could Expand Access to Technologies
Senseonics Completes 365-Day ENHANCE Pivotal Clinical Study, Moves Closer to One-Year Eversense Implantable Sensor Approval
Cardiosense Begins Enrollment in Nationwide Heart Failure Study
NICE Conditionally Recommends AliveCor’s KardiaMobile for Measuring Cardiac QT Intervals in Adults Taking Antipsychotic Medication
MiMedx Group Launches EPIEFFECT for Hard-to-Heal Wounds
FDA Approval for BACKBEAT Study A Major Potential Win for Orchestra BioMed and Medtronic in U.S. Pacemaker Market
ZimVie Receives Approval For Hybrid CDA and ACDF Study Using Mobi-C Cervical Disk Prosthesis
Enovis to Acquire Global Orthopedic Company LimaCorporate
Profound Medical Receives 510(k) Clearance for Thermal Boost AI Module for Use With TULSA PRO Prostate Cancer Ablation Technology
FDA’s CDRH Division Releases Draft Strategic Plan on International Regulatory Harmonization to Lower Redundancy and Reduce Burden on Device Manufacturers
Avita Medical Wins Best Product Award for Second Straight Year at American Association for the Surgery of Trauma Meeting with RECELL Spray-On Skin Cells
CARMAT Reports its First Half 2023 Results and Provides a Strategic Update on Fully Artificial Heart Progress
Vapotherm Study Demonstrates Better Outcomes for Pediatric Asthma Patients Treated with High-Velocity Therapy
Medtronic Receives CE Mark For New Simplera Continuous Glucose Monitoring System
Insightec Receives Humana Coverage for Focused Ultrasound Treatment in Essential Tremor
New State Biomarker Legislation Advocated for by the Cancer Action Network Could Be a Game Changer for Expanding Commercial and Medicaid Access for Advanced Diagnostics
Kaiser Strike Could Have Significant Impact on Patient Care; Sign of Growing Frustration Among Healthcare Workers on Labor Conditions:
Neuralink Gets FDA Approval For First In-Human Use of Brain Implants
Changes in European In-Vitro Diagnostic Device Regulation Will Begin to Impact IVD Manufacturers; New Regulation Structure Will Increase Cost and Evidence Burden to Enter Market
Internet Trend Searches Show Some Signs of Cosmetic/Elective Procedure Softening; Is it the Canary in the Coal Mine for a Softening Healthcare Consumer?
UNH Prior Authorization Changes To Date Unlikely To Significantly Impact Genetic Labs or Imaging Centers; Despite Lobbying Against Burdensome Barriers to Care, to Date There Has Been Minimal Impact
$8 Billion Electrophysiology Market Poised for Potential Shake Up as PFA Technologies Move to the Forefront
QIAGEN Launches New Digital PCR Kits and Software Upgrades for QIAcuity System
Exagen Inc. and Johns Hopkins University Partner to Develop Biomarkers Tests Lupus Nephritis Management
Adaptive Biotechnologies To Conduct Strategic Review Focused on Shareholder Value Following Disappointing 3Q23
Hologic Reports Solid 3Q23; Mammography Backlog Driving Strong Capital Equipment Sales
Strong 3Q23 for Natera; Lots of Momentum with MRD, Potential for Medicare Renasight Coverage, and Improving Reimbursement
Invitae’s 3Q23 Results Drive Further Concern About Long-Term Viability as Cash Burn Goes Wrong Direction and Revenues Decline
COMBINEDBrain Launches WGS Study for Children With Neurodevelopmental Disorders; Broad Institute Will Perform Sequencing Using Fabric Genomics Interpretation Software
23andMe Misses in 2Q24 and Losses Widen; Given Cash Concerns, Management Increasingly Focused on Margins with Price Increases, Headcount Reductions, and Planned Lower Ad Spending
Medicare Recommends Crosswalking 2nd Generation OvaWatch Test from Aspira Labs to Original Ova1 Rate
OraSure Beats Expectations in 3Q23; Investors Focus on Core Growth and Post InteliSwab Growth Drivers
Adaptive Announces Multi-Year Partnership With BeiGene to Assess MRD With clonoSEQ in Blood Cancer Trials
Natera’s Signatera Test to Be Used in European Breast Cancer Study Comparing Elacestrant to Standard Endocrine Therapy; Will Assess Whether Early Intervention Using Signatera Improves Patient Outcomes
Helix Announces Another Major Population Genomics Partnership With Cone Health
Neogenomics Delivers Strong 3Q23 With Profitable Growth; RaDaR MRD Test Currently Undergoing Three Coverage Evaluations from MolDx
Invitae Announces Sensitivity and Workflow Enhancements to its MRD Test
Clinical Volume Growth Slows Sequentially in 3Q23 for Guardant Health; Next Generation Colon Test Data Could Be Interesting if Validated in Large Study Cohort
Myriad Shows Significant Progress With Evident Share Gains in 3Q23; Reimbursement Changes Could Put Company on Course Back to Profitability When Combined With Expense Control
23andMe Makes Pivot to Exome Sequencing With New Offering; Cost Changes in WGS Could Provide a Renaissance for the Company’s Business Model Over Time
Castle Bioscience Delivers Strong Volume Growth in 3Q23 and Makes Major Progress on Profitability
Abbott Joins Crowded HPV Field With FDA Approval of High-Throughput Molecular Test
Natera’s Landmark RenaCARE Study Demonstrates the Ability of Genetic Testing to Dramatically Alter Patient Management in Chronic Kidney Disease; Could Establish Foundation for New Major Genetic Testing Market
QuidelOrtho Outperforms on Respiratory Revenue; Profitability Progress a Positive Despite COVID-19 Headwinds
Exact Sciences Delivers a Strong 3Q23; Signs that Test Acquisition Costs are Declining and Discussion on Pricing Increase for 2nd Generation Cologuard Could Bode Well for Future Profitability
IQVIA Lowers 2023 Outlook and Provides Preliminary Guide for 2024 Calling for Mid-Single-Digit Growth
Agendia’s MammaPrint Test Will be Used to Risk Stratify Patients for NCI Neoadjuvant Immunotherapy Breast Cancer Trial
Guardant Health Tests to Become Available on OncoEMR Platform From Flatiron Health Used by 2,000 Oncologists
23andMe Unveils Health Action Plan Digital Tool; Provides Added Customer Feature and Increases Information in Proprietary Genomic Database
QIAGEN Weathers Macro Storm Better Than Most; QuantiFERON TB Driving Strong Diagnostic Growth
GeneDx Makes Cash Burn Progress in 3Q23 With Goal of Profitability by 2025, However, 4Q Guidance Implies Step Backwards
Revvity Faces Biopharma Challenges, COVID-19 Headwinds in 3Q23
Digital Pathology Solutions Provider Paige Receives FDA Grants Breakthrough Device Designation to Lymph Node Detection Software in Breast Cancer
23andMe and GSK Extend Drug Development Collaboration for Five Years
Foundation Medicine Joins NCI’s ComboMATCH Initiative to Explore New Combination Therapies for Cancer
Labcorp Sees Strong Organic Growth From Hospital Outsourcing Deals Overcoming COVID-19 Headwinds
Personalis Announced Early Access Launch of NeXT Personal Dx MRD Test With Focus on Lung Cancer, Breast Cancer, and Immunotherapy Response
QIAGEN and Myriad Announce CDx Collaboration Focused on Kitting Advanced Diagnostics
C2N Diagnostics Licenses and Introduces Novel Fluid Biomarker for Alzheimer’s Disease
ICON Follows in Medpace Holdings Footsteps With Strong Booking Trends; Supports Continued Strength in Pharma Research
Aspira Women’s Health Study Shows Combining miRNA and Protein Biomarkers Improves Diagnostic Accuracy of Ovarian Cancer Test
Metabolon Partners With Genomics England to Provide Metabolomic Data on 7,000 Patients From 100,000 Genomes Project to Find Rare Disease Biomarkers
Mindray Launches Two New Cardiac Biomarker Tests for Myocardial Infarction and Heart Failure
BostonGene Partners With Exigent Research on Clinical Utility Study for the Tumor Portrait Test
MeMed Gets BARDA Contract for Novel Test to Differentiate Bacterial and Viral Infections
Invitae Releases Study Highlighting Unknown Variant Rates in Large Genetic Panels
Prostatype Interim Analysis Demonstrates Ability to Alter Patient Management and Predict Disease Progression
Caris Signs Research Collaboration with mRNA Leader Moderna, Now Has Over 70 Biopharma Partnerships
Quanterix Enhances Alzheimer’s Offering With License to Johnson & Johnson’s p-Tau 217 Antibodies
Quest Reports Continued Strong Core Requisition Growth in 3Q23 and Solidifies Payer Contracts; LDT Regulation and PAMA Reform Remain Uncertainties
USC Researchers Develop New Accurate Blood Test for Assessing Ovarian Cancer in Patients With Adnexal Masses
Danaher 3Q23 Results Show Continued Headwinds From Bioprocessing, China, and COVID-19; Management Believes Inventory Draw Downs Will Lead to Improved Trends in 2024
Neogenomics Launches Comprehensive Genomic Profiling Test for Hematomalignancies; Could Be a Strong Compliment to Existing Anatomic Pathology Franchise
Medpace Holdings, Inc. Posts Strong Q3 2023 Results and Guides Above Street for 2024; Strong Read-Through on Biopharma Investment
Data from GALAXY Study Shows Ability of Natera to Predict Outcomes and Benefit of Adjuvant Chemotherapy in Resectable Colorectal Cancer
Personalis Data from TRACERx for MRD Test Appears on Par With Market Leader Natera
Genoscopy Data Good, But Tough Hill to Climb Commercially Given Next Generation ColoGuard Test is More Accurate
BLUE-C Trial Will Make It Even More Challenging for Imitators; Extends Exact Sciences’ Lead in Non-Invasive Colorectal Cancer Detection
Foundation Medicine Agrees to Tech Transfer with Sequanta Technologies to Support Clinical Trials for Oncology Medicines in China
UNH Arbitration Rulings on Unpaid Claims Could Have Significant Ramifications for Insurance Companies and Service Providers
Foundation Medicine Announces Positive Data from CUPISCO Study in Difficult to Treat CUP Patients Will be Presented at ESMO
Thermo Fisher Scientific and Boehringer Ingelheim Partner to Advance Precision Cancer Therapies
Microba Life Sciences Acquires Invivo in Deal Valued at up to A$21.5 Million; Strengthens Position in Microbiome Testing Market
Phenomix’s MyPhenome Hungry Brain Test Shows Ability to Predict Response to Weight Loss Drug Qsymia
VolitionRx’s Nu.Q® NETs Test Shows Promise in Study as Sepsis Severity Biomarker
Ancestry Launches Genetic Traits Feature Allowing Customers to Determine 43 Inherited Parental Characteristics
New CRISPR Diagnostic Company VedaBio Announces $40 Million Funding & Platform Launch; Unclear Whether Technology Uses Existing Intellectual Property
SOPHiA GENETICS Partners with Memorial Sloan Kettering and AstraZeneca To Broaden Access to Advanced Cancer Tests
Telo Genomics Announces Launch of Smoldering Multiple Myeloma Test in the U.S.
Abbott Reports Strong Third-Quarter 2023 Results With Medical Device Sales up 15% Organically, Diagnostics up 6% Excluding COVID-19
AMP Clinical Practice Committee Working Group on Liquid Biopsy Publishes Recommendations to Standardize Industry Practices
Eurobio Introduces New Rapid Sequence Based Typing Test for HLA Testing Using Oxford Nanopore Long-Read Technology
Revvity Expands Newborn Screening Mass Spectrometry Offering Through SCIEX Partnership
HCA Healthcare Partners with GRAIL to Offer Galleri Liquid Biopsy Test
Thermo Fisher Pays Big Multiple for Olink; Deal Expected to Accretive Year One Based on Substantial Cost/Revenue Synergies
ProPhase Labs Announces Rapid Manufacturing Growth at CDMO Subsidiary Given Demand for Cold Lozenges
bioMérieux Receives CE-Marking for Blood Test for Traumatic Brain Injury
Following Failed Strategic Alternative Process; Biocept, Inc. Files for Chapter 7 Bankruptcy, Announces CEO/Board Resignation
Charles River Laboratories Expands Access to Pediatric PDX Collection Following FDA/EMA Regulations Mandating Pediatric Testing for New Oncology Drugs
InterVenn Biosciences Announces New Publication On Colorectal Cancer Multivariable Classifier Model; Aims to Launch Colon Cancer LDT in 2023
Biocartis and APIS Expand Partnership in Breast Cancer with ESR1 Test Added to ASCO Guidelines in May
New Naveris Studies Show Potential for Viral DNA as a MRD Marker in Oropharyngeal Cancers
T2 Biosystems Pre-Releases 3Q23 Results; Announces Additional FDA Submission for Sepsis Test
Invitae Study Furthers Argument Supporting Hereditary Cancer Testing for all Breast Cancer Patients
Foundation Medicine Receives 2nd CDx Indication of the Week With FDA Approval for BRAF V600E mutations in Pfizer Combination Therapy for NSCLC
Cardio Diagnostic Holdings Announces New Lab for Proprietary Heart Disease Tests; Focused on Cost Reduction
Veracyte Studies at CHEST Demonstrate Envisia’s Ability to Aid in Diagnosis of Interstitial Lung Disease
Epigenomics AG Finalizes Asset Acquisition Agreement with New Day Diagnostics; Companies to Develop Next Generation Colon Cancer Blood Test
Fibronostics and Stone Diagnostics Partner to Advance Non-Invasive Liver Disease Assessment
Clinical Microbiomics A/S and CosmosID Inc. Merge to Create the Global Leader in Microbiome Research Services
Study Demonstrates Pathnostics Guidance UTI Test Lowers Antibiotic Use and Hospitalizations in Complex UTI Cases
New Report from NCI Highlights Impact of COVID-19 on Rates of Cancer Diagnosis
Quidel Pre-Releases 3Q23 Revenue; Strong Respiratory Revenue a Positive Read-Through for Other COVID-19 Test Manufacturers
Class Action Complaint Against 23andMe, Inc. Filed in California District Court Accuses Company of Data Negligence
GE Healthcare and SOFIE Biosciences Partner on FAP Radiopharmaceuticals Shown to Be Highly Prognostic in Cancer Studies
SYNLAB Launches New Test to Differentiate Bipolar Disorder and Depression; Clinical Validation Shows High Accuracy Using Novel RNA Biomarkers
Labcorp Launches New Blood Test for Early Alzheimer’s Detection; Follows Trend in Biomarker Development and Testing Following Leqembi Approval
Fujirebio and Sysmex Announce Bolstered Global Immunoassay Partnership; Deal Will Look to Leverage Combined Strengths
Karius Study Demonstrates the Ability for NGS Technology to Better Detect/Treat Pneumonia Pathogens in Immunocompromised Patients
Tecan Sues QIAGEN and Invitae Over Next Generation Sequencing Sample Preparation Patents
AdvaMed Announces New Digital Health Tech Division
Foundation One Announces FDA Approval for Companion Diagnostic Indication for Retevmo in Cancers With Rare RET Gene Fusions
Foundation Medicine and Natera Launch Full Commercial Launch of FoundationOneTracker Utilizing Signatera for Treatment Response Monitoring
Exact Sciences to Release Full BLUE-C Study Results at ACG
EU Regulators Rumored to Be on the Cusp of Ordering Illumina to Sell Grail
23andMe Investigates Unauthorized Access to Customer Accounts
Neway and Quest Diagnostics Partner to Improve Dialysis Patient Care
Renalytix Receives Patents on Foundational Biomarkers for the KidneyIntelX.dkd Test
KDx Diagnostics Issued Patents for Keratin 17 Biomarker in Bladder Cancer
A Deeper Dive Into Grail PATHFINDER Study Highlights Key Clinical Challenges; Unlikely to Be the Path to Broad Adoption and Insurance Coverage
EntroGen Receives FDA Approval for CRCdx® RAS Mutation Detection Kit as Companion Diagnostic for Vectibix®
Labcorp to Acquire Baystate Health’s Outreach Laboratory Business; PAMA Driving Continued Lab Consolidation
QIAGEN Launches QuantiFERON-EBV RUO Assay to Advance Research on Epstein-Barr Virus Immune Response
CSPI Sues EpicGenetics Based Upon Claims of False and Misleading Statements on Fibromyalgia Test
A New Study from Metabolomic Diagnostics Demonstrates the Potential for Blood Biomarkers to Improve Preeclampsia Risk Stratification in Pregnant Women
Castle Biosciences’ Study on DecisionDx-Melanoma Tool Demonstrates Ability to Predict Which Patients Should Receive Sentinel Node Biopsy
Natera Study Demonstrates Ability of Signatera To Guide Clinical Decision Making in Unresectable NSCLC Patients
Cue Health Study Shows High Correlation With POC COVID-19 Test and Laboratory PCR
Eurofins Expands CDMO Capabilities in North America with New Canadian Facility
ASCO Issues New Recommendations Aimed to Address Ovarian Toxicity in Cancer Clinical Trials
Serimmune Study Identifies Significant Biological Distinctions Associated with Long COVID-19
Standard BioTools and SomaLogic Announce Merger; Investors Appear to Question Strategic Rationale Given Differing Business Models
Oxford BioDynamics Receives New PLA Code for EpiSwitch PSE Prostate Cancer Test
FDA Grants Market Authorization for Invitae’s Common Hereditary Cancers Panel; Marks First FDA Approved Multi-Gene Panel
Promega Partners with GSK to Develop MSI Companion Diagnostic IVD Kit for Jemperli
BostonGene Partners with Johns Hopkins University School of Medicine Furthering Strategic Research Partnerships
Castle Biosciences to Present New Data on DecisionDx-SCC at ASTRO 2023 Annual Meeting
Renalytix kidneyintelX.dkd Test Priced at $950 by Medicare
Exact Sciences Subsidiary Genomic Health Settles Qi Tam Lawsuit for $32.5
Advent International and Warburg Pincus Finalize Acquisition of Baxter’s BioPharma Solutions Business
U.S. Supreme Court Declines to Hear CareDx’s Lawsuit Over Organ-Rejection Tests; Maintains Status Quo on Intellectual Property for Advanced Diagnostic Patents
Natera Submits First Module of PMA Application for Signatera as Companion Diagnostic for Muscle-Invasive Bladder Cancer
Castle Biosciences’ TissueCypher® Test Demonstrates Potential to Guide Clinical Decisions in Non-Dysplastic Barrett’s Esophagus Patients
FDA Issues Proposed Rule for Laboratory Developed Tests; Proposes Four Year Phase Out Plan
European Reference Laboratory SYNLAB Enters Investment Agreement with Private Equity Firm Cinven for Public Acquisition Offer
Phenomix Sciences Receives Patent for Obesity Phenotyping Test
Avantect Pancreatic Cancer Test Receives CPT Code and Preliminary Payment Determination from the Centers for Medicare and Medicaid Services (CMS)
MINT Subanalysis Demonstrates Mammaprint + BluePrint’s Ability To Predict Response to Neoadjuvant Chemotherapy in Stage 2&3 Lymph Node Positive Breast Cancer
Nevisense Studies Demonstrate the Ability of the Device to Diagnose Skin Barrier Dysfunction Including Atopic Dermatitis in Children
Veracyte’s Afirma-Based Testing Reveals Novel Molecular Insights into Thyroid Cancer; Company Launches GRID Technology to Further Genetic Understanding of Thyroid Cancer
QIAGEN Expands Clinical Decision Support Software with AI-Enhanced Rare Disease Gene Coverage
GRAIL Expand Access to Galleri® Multi-Cancer Early Detection Blood Test to Tufts Health Plan and Harvard Pilgrim Health Care in First Commercial Health Plan Collaboration
Syneos Health Closes Transaction With Private Investment Firms
FDA Clears Thermo Fisher’s CgA Test for Rare Neuroendocrine Tumors
Hilary Gee Goeckner From Cancer Action Network Discusses New Biomarker Legislation
Study Shows Promising New Tau PET Tracer [18F]SNFT-1 Could Improve Early Alzheimer’s Detection
Myriad Survey Shows High Percentage of Women Pooly Informed on Breast Density Status/Risks and Family Health History Pertaining to Cancer Risk
Clario and CellCarta Collaborate to Improve Histopathology Services in Clinical Trials
Biocartis Group Announces Recapitalization and Wind Down Agreement; Deal Foreshadows Other Likely Future Debt Restructurings in Med-Tech
Biden-Harris Administration Invests $600 Million to Boost U.S. COVID-19 Test Manufacturing and Reopens COVIDTests.gov; Public Attitudes Toward COVID-19 Testing Changing
MDxHealth SA and University of Oxford Collaborate on Study to Evaluate the Correlation Between Genomic Prostate Score and Prostate Cancer Progression
Oxford BioDynamics Launches EpiSwitch Prostate Screening Blood Test in the US
QuidelOrtho Receives First CLIA Waiver for a Flourescent Immunoassay Based COVID-19 Test; Still No Clarity on When the Emergency Use Authorizations for COVID-19 Tests Will Expire
CEO of Microba, Dr. Luke Reid Discusses the Future of the Microbiome for Clinical Use
Ginkgo Bioworks Partners With Republic of Madagascar to Enhance Biosecurity – Follows String of Biosecurity Announcements for the Company’s Concentric Division
Charles River Laboratories Announces New Advanced Therapy Lab in UK to Better Serve Customers
Valo Health and Novo Nordisk Sign Partnership to Harness Valo Health AI-driven Drug Discovery Tools
CareDx Notified that the SEC Will Not Pursue Enforcement Action Following Investigation
New State Biomarker Legislation Advocated for by the Cancer Action Network Could Be a Game Changer for Expanding Commercial and Medicaid Access for Advanced Diagnostics
Kaiser Strike Could Have Significant Impact on Patient Care; Sign of Growing Frustration Among Healthcare Workers on Labor Conditions:
Changes in European In-Vitro Diagnostic Device Regulation Will Begin to Impact IVD Manufacturers; New Regulation Structure Will Increase Cost and Evidence Burden to Enter Market
CEO of Sherlock Biosciences, Bryan Dechairo Discusses the Potential Diagnostic Revolution With CRISPR Diagnostics
GM of Organ Health at Natera, Bernie Tobin Discusses Evolving Transplant Diagnostic Market
UNH Prior Authorization Changes To Date Unlikely To Significantly Impact Genetic Labs or Imaging Centers; Despite Lobbying Against Burdensome Barriers to Care, to Date There Has Been Minimal Impact
Illumina 3Q23 and Guidance Ugly, However Post-Grail Profitability Likely to Get Value Investors and Acquirers to Start Taking a Look
Oxford Nanopore Announces Strategic Acquisition of Northern Nanopore Instruments to Boost Solid-State Nanopore Development Program
No Suprises With Challenging 3Q23 and Outlook for Waters Following Peer Reports; Profitability Exceeds Expectations Though
QIAGEN Announces Launch of New Sample-to-Answer Microbiome Research Solution
Oxford Nanopore Announces Collaboration with Genomics England to Support 100,000 Genomes Project Rare Disease Initiative
10x Genomics Shows Strong Momentum With Xenium Spatial Biology Platform Overcoming China and Macro Headwinds
Repligen Launches New TangenX SC Filtration Technology for Bioprocessing
New QIAGEN and Element Biosciences Partnership Improves Workflow, Data Analytic Offerings for Element’s Disruptive AVITI Sequencer
Somalogic Expands Proteomics Testing Platform to Encompass 11,000 Proteins
Illumina Launches Next Generation of its Liquid Biopsy Assay for Cancer Genomic Profiling; Offers Key Workflow Enhancements and Increased Sensitivity
PacBio Expands Tertiary Analysis Ecosystem With Two New Genomic Analysis Software Partners
NCI Researchers Develop Innovative Approach to Significantly Boost T-Cell Therapies Against Solid Tumors
Bio-Techne Comes in Under Forecasts But Still Grows in Challenging Macro Backdrop; Levered to High Growth End Markets in Cell/Gene Therapy and Spatial Biology
Oxford Nanopore and Fabric Genomics Collaborate on Pediatric Genomic Solution Set Using Nanopore Sequencing Technology and Fabric’s Informatics
Repligen 3Q23 Better Than Expected Among Backdrop of Biopharma Challenges; Optimistic Signs for Improvement in 2024
Twist Bioscience Launches New “PCR Free” Multiplexing Chemistries for Sequencing
QIAGEN Weathers Macro Storm Better Than Most; QuantiFERON TB Driving Strong Diagnostic Growth
PacBio Defies Market Backdrop in 3Q23 With Revio and Onso Product Cycles Just Starting
Revvity Faces Biopharma Challenges, COVID-19 Headwinds in 3Q23
Bio-Rad Joins Peers With Ugly Life Science Results in 3Q23
West Pharmaceutical Services Lowers Full-Year Outlook Citing Customer Inventory Control; COVID-19 Headwinds Abating and GLP-1 Represents Future Growth Driver
Beckman Coulter and 10x Genomics Partner on Single Cell Automation Solutions
Oxford Nanopore Partners With Saphetor To Improve Clinical Data Interpretation
Thermo Fisher 3Q23 Results and 2023 Guidance Forbodes Further Weakness in Life Science Tools; Management Anticipates Headwind Abatement in 2H24
Bio-Techne to Showcase Spatial Biology Solutions in Cancer at SITC Meeting; Working Toward Multiomic Automated Solution Following Lunaphore Acquisition
Quanterix Enhances Alzheimer’s Offering With License to Johnson & Johnson’s p-Tau 217 Antibodies
Danaher 3Q23 Results Show Continued Headwinds From Bioprocessing, China, and COVID-19; Management Believes Inventory Draw Downs Will Lead to Improved Trends in 2024
Ginkgo Bioworks Signs New Collaboration With Penn State To Monitor COVID-19 Variant Evolution in Wild Animals
BioLife Solutions Pre-Releases Disappointing Q323 Due to Bioprocessing Slowdown; Company Also Announces Key Leadership Transitions
Ginkgo Bioworks Announces Research and Biomonitoring Partnership with Serbian Government
Thermo Fisher Scientific and Boehringer Ingelheim Partner to Advance Precision Cancer Therapies
Oxford Nanopore Receives £70M Strategic Investment from bioMérieux; Signs New Research Collaboration with Mayo Clinic
Waters Corporation Launches New OligoWorks™ SPE Kits in High-Growth Therapeutic Market
Eurobio Introduces New Rapid Sequence Based Typing Test for HLA Testing Using Oxford Nanopore Long-Read Technology
Revvity Expands Newborn Screening Mass Spectrometry Offering Through SCIEX Partnership
Thermo Fisher Pays Big Multiple for Olink; Deal Expected to Accretive Year One Based on Substantial Cost/Revenue Synergies
Ginkgo and Persephone Complete Collaboration on Toolkit to Create Custom Bacteroides for Life Science Research and Pharmaceutical Development
Mesa Labs Completes Acquisition of GKE-GmBH’s Sterilization Indicators Business; Should Accelerate Growth Following Recent Headwinds
Disruptive Benchtop Sequencer Manufacturer Element Biosciences Signs Partnership with Revvity on Workflow Solutions
Illumina Provides Update Following EC Order to Divest GRAIL
BIOCAPTIVA Launches New Study to See if BioCaptis cfDNA Enrichment Device Can Enhance Accuracy of Lung Fluid Biopsies
European Commission Orders Illumina to Unwind GRAIL Acquisition; Deal Will Unlock Near-Term Accretion but Valuation a Concern
QL AG and Ginkgo Bioworks Collaborate to Foster Sustainable Dairy Protein Production
PacBio Unveils New Data Analysis Tool for Whole Genome Sequencing; Continues to Up its Game in NGS Market
Tecan Sues QIAGEN and Invitae Over Next Generation Sequencing Sample Preparation Patents
10x Genomics Announces UPC Has Declined to Issue Second Preliminary Injunction Against NanoString in Spatial Genomics Dispute
NanoString Pre-Releases Positive 3Q23 Results Showing Accelerating Spatial Biology Revenue and Announces Restructuring; Focus Still on Freedom to Operate
Terumo BCT and BioCentriq Partner to Develop More Efficient CAR-T Cell Manufacturing; Plan to Publish Data at Upcoming Conferences in 2024
Ginkgo Bioworks and Northeastern University to Aid in CDC Funded Program for Epidemic Monitoring and Prevention
Twist Bioscience Announces Antibody Discovery Agreement with Bayer Worth Up to $188 Million
Bruker Announces Majority Investment in Swiss Spectroscopy Gas Analyzer Company
Standard BioTools and SomaLogic Announce Merger; Investors Appear to Question Strategic Rationale Given Differing Business Models
Bruker Corporation Completes Acquisition of PhenomeX
A*STAR’s Genome Institute of Singapore, NanoString, and Next Level Genomics Establish Joint Lab for Spatial Genomics Research
Angle’s Parsortix System Outperforms Density Centrifugation Method For Isolating Tumor Cells
Nosh.bio Collaborates with Ginkgo Bioworks to Improve Flavor of Fungal Meat Alternatives
nRichDX® Launches CTC Enrichment Kit on Revolution Sample Prep System
UPC Ruling in Favor of 10x Genomics Leads to Injunction Against NanoString in 17 EU Countries; Spatial Genomics Legal Battle Heating Up With U.S. Trials Pending
Integrated DNA Technologies Develops First Sequencing Chemistries Specifically Designed for the Potentially Disruptive Ultima UG 100 Sequencer
Concentric By Ginkgo and Texas A&M University Awarded USDA NIFA AFRI Grant to Conduct Genomic Animal Research to Prevent Zoonotic Disease Spillover
QIAGEN Expands Clinical Decision Support Software with AI-Enhanced Rare Disease Gene Coverage
Revvity Introduces Pin-point™ Base Editing Reagents to Researchers to Accelerate Genomic Discovery
Ensovi Partners with Ginkgo Bioworks to Advance Sustainable Biomanufacturing
Bionano Genomics Highlights Peer Reviewed Study Showing High Concordance Between Optical Genome Mapping (OGM) and Chromosomal Microarray Analysis
Abcam Founder Writes Letter Expressing Dissatisfaction with Danaher Acquisition; Campaign Unlikely to Succeed
Ginkgo Bioworks Collaborates with Pfizer for RNA-Based Drug Discovery
Twist Bioscience and IMIDomics Join Forces for Immune-Mediated Inflammatory Disease Antibody Discovery
Recent Studies Published in Nature Demonstrate the Utility of RareCyte’s Orion Spatial Biology Platform
Bio-Techne Integrates Maurice Chromotography Platform With Thermo Scientific Chromeleon Data System
Repligen Acquires Swedish Company Bolstering Fluid Management Offering to Bioprocessing Customers
Charles River Launches New Gene Therapy Manufacturing with Lentivation™ Platform; Dramatically Shortens Manufacturing Timelines
908 Devices Begins Roll-Out of Biothreat Detection Systems in Support of Department of Defense AVCAD Program
QIAGEN Offers New Sustainable Solutions for its Market Leading DNA Extraction Technologies
CEO of Microba, Dr. Luke Reid Discusses the Future of the Microbiome for Clinical Use
Valo Health and Novo Nordisk Sign Partnership to Harness Valo Health AI-driven Drug Discovery Tools
New State Biomarker Legislation Advocated for by the Cancer Action Network Could Be a Game Changer for Expanding Commercial and Medicaid Access for Advanced Diagnostics
Kaiser Strike Could Have Significant Impact on Patient Care; Sign of Growing Frustration Among Healthcare Workers on Labor Conditions:
Singular Genomics CEO, Drew Spaventa Discusses Disruptive Technology in Sequencing Market
Ultromics Receives HOPPS Code for EchoGo Heart Failure in Outpatient Setting Following Inpatient Reimbursement Earlier this Year
Labcorp to Offer New Fertility/Family Building Service Offering to Employers/Health Plans Through Ovia Health Subsidiary
Abbott Study Shows its Healthy Food Rx Program Can Improve Outcomes Around Diabetes
Hims & Hers Momentum Train Continues With 56% Subscriber Growth and 19% Growth in Average Revenue Per Order Despite Weakening Consumer Backdrop
Microbiome Wellness Company Viome Acquires Multi-omics Wellness Company Naring Health To Combine Expertise and Expand Offerings
GE Healthcare Study Shows that AI and Imaging May Play a Role in Checkpoint Inhibitor Selection for Cancer Patients
Billing Software Leader Waystar to Delay IPO Based Upon Market Conditions; Shows Continuing Challenging Environment for Healthcare IT Providers
McKesson Beats in 3Q23, GLP-1 Drives Increased Pharma Segment Revenue and Increased Prescription Technology Solutions Due to Prior Authorization Service Demand
Digital Health and Disease Management Company DarioHealth Launches Blood Sugar Meter Designed for Use With iPhone 15
PacBio Expands Tertiary Analysis Ecosystem With Two New Genomic Analysis Software Partners
TeraRecon Collaboration With Avicenna.AI Will Add Two New AI-Based Imaging Interpretation Applications in Pulmonary Embolism and Aortic Dissection to Eureka Software Platform
Fresenius Announces Apollo Database Project to Glean Clinical Insights From 540,000 Dialysis Patients
Teladoc Health Focuses On Profitability And Misses Revenue Targets
Metabolic Health App Developer, Signos, Raises $20M in Series B Funding Including Investment from Dexcom Ventures
Lucida Medical Gets CE Mark for Prostate MRI CAD Technology in Europe Using AI; Data Shows Impressive Ability to Improve Sensitivity and Reduce Unnecessary Biopsies
Telehealth Solutions Provider Headway Raises $125 Million in Series C Round; Plans Continued Expansion in Mental Health
DOD Selects Amwell Converge Platform for Telehealth Offering and Digital Care Solutions
Spring Health Launches Atlas AI Tool to Empower HR Leaders on Behavioral Health Data Management
AI Billing Company Waystar Files to Go Public; Ends Drought of Healthcare IT IPOs
Evidation Receives BARDA Contract to Use Wearable Devices in Flu Monitoring
Medacta Study in Shoulder Arthroplasty Further Demonstrates the Potential of Augmented Reality in Orthopedics
GoodRx Partners With Navitus on Collaboration to Improve Drug Price Transparency at Pharmacies
DaVita Releases Statement Following Stock Sell-Off on Novo Nordisk’s GLP-1 Study Announcement
iCAD CEO Dana Brown Discusses Future of AI in Imaging Technologies
Mendel Launches Hypercube AI-Tool for Analyzing Life Sciences and Healthcare Data
Highmark Expands Access to Spring Health Powered Mental Health Program
TeraRecon and FEops Announce Collaboration for Structural Heart Planning Procedures
Butterfly Network Introduces New Education Support Tools
23andMe Investigates Unauthorized Access to Customer Accounts
Teladoc Health Teams Up with Sword Health to Enhance Musculoskeletal Health Care
GE Healthcare Integrates Caption Guidance Heart Failure AI Technology Into Ultrasound Solutions
Neway and Quest Diagnostics Partner to Improve Dialysis Patient Care
Nestle/Amwell Partnership Matches Amwell’s Automated Care Solutions with Nestle Nutrition Expertise
Verily Launches Viewpoint Workbench to Expedite Biomedical Research
Commure and Athelas to Merge to Gain Scale and Drive Efficiency; Consolidation an Increasing Trend in Healthcare IT
Ginkgo Bioworks and Northeastern University to Aid in CDC Funded Program for Epidemic Monitoring and Prevention
Covetrus Signs Partnership with Vetcor Making them the Primary Provider of Vet Software Solutions
Sonde Health and Together Team Up to Enhance Virtual Mental Health Monitoring
Butterfly Network and Razom Partner to Expand Access to Butterly iQ+ Ultrasound Technology in Ukraine
HealthTap and Health Gorilla Join Forces to Facilitate Access to Medical Records
Fresenius Accused of Medical Fraud in New Qui Tam Lawsuit
BostonGene Partners with Johns Hopkins University School of Medicine Furthering Strategic Research Partnerships
Sword Health and Costco Health Solutions Partner on Digital Physical Therapy and Lifestyle Solutions
Anumana Receives FDA 510k Approval for New AI Powered Heart Failure Diagnosis Technology
Lyra to Launch Benefit Ecosystem Tool in January 2024
Boehringer Ingelheim and ZEISS Partner to Prevent Vision Loss; Partnership Aims to Create AI Tools and Early Predictive Markers for Eye Disease
Following Lobbying by Radiologist Societies, CMS Allows for Billing of Multiple Cardiac MRI Procedures
Spring Health Expands Substance Use Disorder Support Services Through Partnership with Eleanor Health
Chronic Disease Management Company Lark Health Expands Personalized Weight Management Solutions to Support GLP-1 Medication Demands
Komodo Health Introduces MapLab™: An Integrated Solution for Healthcare and Life Sciences Insights
TeraRecon’s Eureka Clinical AI Platform Automates Cardiovascular Disease Diagnosis Utilizing Advanced AI
Beacon Receives FDA Approval for Dreem 3S; Facilitates Collection of High Quality Sleep Data in the Home Setting
Kidney Disease Management Company Renalytix Reports Full Year Results; Mitigating Cash Burn Key to Future Success
Augmedix Introduces Augmedix Go: A Clinician-Controlled Mobile App Using Generative AI for Automated Medical Notes
Virtual Primary Care Provider HealthTap Launches Enhanced Version of Dr.A.I. Which Automates Patient Interviews
Somatus Receives Validation of Claim that it Reduces Hospital Readmissions for Patients With Kidney Disease
FDA Issues Final Guidance Document on Cybersecurity Requirements for Premarket Device Submissions
Cardiosense Begins Enrollment in Nationwide Heart Failure Study
NICE Conditionally Recommends AliveCor’s KardiaMobile for Measuring Cardiac QT Intervals in Adults Taking Antipsychotic Medication
Costco Continues Trend Among Retailers to Offer Primary Care Services Utilizing Telehealth Networks; Could Change Care Delivery in the United States
Hinge Health Launches Enhancements to Women’s Pelvic Health Program
Axxess and Gateway Home Health Coding & Consulting LLC Form Strategy Partnership
Ginkgo Bioworks Partners With Republic of Madagascar to Enhance Biosecurity – Follows String of Biosecurity Announcements for the Company’s Concentric Division
Valo Health and Novo Nordisk Sign Partnership to Harness Valo Health AI-driven Drug Discovery Tools
New State Biomarker Legislation Advocated for by the Cancer Action Network Could Be a Game Changer for Expanding Commercial and Medicaid Access for Advanced Diagnostics
Kaiser Strike Could Have Significant Impact on Patient Care; Sign of Growing Frustration Among Healthcare Workers on Labor Conditions:
How a Robot Could Be Reading Your Next Mammogram – AI Tools in Development at Google Health and iCAD Poised to Improve Care, Reduce Costs, and Perhaps Ultimately Replace Human Interpretation
Dentsply Sirona Investor Day Focuses on Streamlining Strategy and Utilizing Digital Assets to Drive 15% Earnings Growth CAGR From 2023-2026
IDEXX Launches New Rapid Antibody Test for Leishmaniosis on SNAP 4Dx Platform
Elanco Animal Health Suprises to Upside Following Mixed Commentary from Animal Health Peers, Concerns Over Declining Vet Visits
Dentsply Sirona Follows Peers With Challenging 3Q23; Notes Survey Data Showing Declining Global Volumes and Increased Cancellations
Zoetis Fares Better Than Rival IDEXX in 3Q23 With Solid Companion Animal Growth
Envista Earnings Show Dental Market Macro Headwinds; Clear Aligner Strength a Bright Spot
ZimVie’s 3Q23 Better than Tepid Expectations, but Elective Procedure Headwinds in Dental Likely to Worsen and U.S. Spine Competition Unlikely to Abate
IDEXX 3Q23 Shows Beginning Signs of a Vet Consumer Slowdown; Pricing Drives Majority of Growth in Quarter, But is it Sustainable
Align Sees Significant Slowdown in 3Q23 and Guides to Ugly 4Q23; Is it a Harbinger for Elective Procedures, Competition, or Both?
Alveo and Corteva Announce Partnership for Handheld, Point-of-Care Agriculture Testing Solution
Dentsply Sirona Launches New Outcome Simulation Tool; Competes with Similar Offerings from Market Leader Align Technology
New Dental Care Study Using Delta Dental Claims Shows Substantial Reduction in Preventive Care Visits Long After Initial Stages of the Pandemic Leading to Increased Interventions Now
ZimVie Announces Launch of Azure Product Solutions to Strengthen Offering to Dental Laboratories
OraQ Launches AI Driven Support Tool For Dentists in U.S.; Joins Increasingly Crowded Field of Solution Providers
QL AG and Ginkgo Bioworks Collaborate to Foster Sustainable Dairy Protein Production
ZimVie Launches New Bio-Active Membrane for Dental Surgery
Sonendo Pre-Releases In-Line Preliminary Financial Results for Q3 2023; However, Guidance Implies Improving 4Q Trend
Sonendo Announces Two New DSO Partnerships for its GentleWave System
Covetrus Signs Partnership with Vetcor Making them the Primary Provider of Vet Software Solutions
SmileDirectClub Files for Chapter 11 Bankruptcy Protection, Announces Financial Restructuring To Fund Ongoing Operations
Corteva Files Lawsuit Against Inari USA Alleging Intellectual Property Theft and Patent Violations for Bio-Engineered Seeds
Concentric By Ginkgo and Texas A&M University Awarded USDA NIFA AFRI Grant to Conduct Genomic Animal Research to Prevent Zoonotic Disease Spillover
Sonendo Introduces Second Generation CleanFlow™ Procedure Instrument for Enhanced Root Canal Treatment
Harpe Bioherbicide Solutions Licenses CRISPR-Cas9 Technology from Corteva Bioscience and the Broad Institute of MIT/Harvard to Develop New Crop Systems Tolerant to Harpe Bioherbicides
FDA’s CDRH Division Releases Draft Strategic Plan on International Regulatory Harmonization to Lower Redundancy and Reduce Burden on Device Manufacturers
Dentsply Sirona Highlights New Technologies at Las Vegas Professional Education Event
New State Biomarker Legislation Advocated for by the Cancer Action Network Could Be a Game Changer for Expanding Commercial and Medicaid Access for Advanced Diagnostics
There is an Increasing Trend Toward Increased Dental Coverage for Medicaid Patients Across the United States
Kaiser Strike Could Have Significant Impact on Patient Care; Sign of Growing Frustration Among Healthcare Workers on Labor Conditions:
Align Technology Facing Emboldened Established Competitors and New Venture Backed Competition; Will it Maintain its Market Dominance in Clear Orthodontics?
Mars Petcare Quietly Laying Strategic Groundwork to Be a Major Player in Veterinary Diagnostic Market – Could it Impact Market Leaders Idexx and Zoetis?
Animal Health/Food Safety/Dental
A Veterans Day Thank You to Captain Jeremy Fresques
Captain Fresques grew up in Farmington New Mexico, a small rural town near the Four Corners. He was a star athlete and outstanding student and could have done anything in life. He was also a person who wanted to make a difference in the world, so upon graduation he was
[…]
Final LCDs from MACS Lead To Questions on Coverage for Certain MIGS Procedures for Glaucoma Treatment
11-10-23 (by: Scott Gleason) A series of decisions by Medicare Administrative Contractors (MACs) is causing concern among healthcare providers and patients as they signal significant shifts in the coverage of Micro-Invasive Glaucoma Surgery (MIGS). On November 9, 2023, four prominent MACs—Palmetto GBA, Celerian Group Company, National Government Services, and Noridian
[…]
Dentsply Sirona Investor Day Focuses on Streamlining Strategy and Utilizing Digital Assets to Drive 15% Earnings Growth CAGR From 2023-2026
11-10-23 (by: Scott Gleason) Dentsply Sirona recently hosted its investor day where the company laid out plans to reach $3.00 per share in adjusted earnings by 2026 (compared to consensus forecasts for 2023 of $1.98. This would imply a three-year earnings CAGR of 15% which the company plans to achieve
[…]
QIAGEN Launches New Digital PCR Kits and Software Upgrades for QIAcuity System
11-10-23 (by: Scott Gleason) QIAGEN has announced the launch of a suite of new digital PCR kits designed for use with its QIAcuity systems focused on the areas of cell and gene therapies, DNA and RNA quantification, as well as food and pharmaceutical safety. The company also announced new software
[…]
Exagen Inc. and Johns Hopkins University Partner to Develop Biomarkers Tests Lupus Nephritis Management
11-10-23 (by: Scott Gleason) Exagen has joined forces with Johns Hopkins University as the two entities jointly announced the execution of an exclusive license agreement designed to advance the development of novel patented biomarkers for lupus nephritis. Under the terms of this exclusive agreement, Exagen is set to acquire a worldwide
[…]
Adaptive Biotechnologies To Conduct Strategic Review Focused on Shareholder Value Following Disappointing 3Q23
11-10-23 (by: Scott Gleason) Adaptive Biotechnologies has released its financial results for the third quarter reporting total revenue of $37.9 million for the third quarter of 2023 a 21% decrease compared to the same quarter in 2022. Street estimates had called for total revenue of $43 million. Management noted an
[…]
Hologic Reports Solid 3Q23; Mammography Backlog Driving Strong Capital Equipment Sales
11-10-23 (by: Scott Gleason) Hologic has announced its financial results for the fourth quarter of fiscal 2023 reporting total revenue of $945.3 million for the fourth quarter of 2023, reflecting a decrease of 0.8% compared to the previous year. The decline was attributed to reduced sales of COVID-19 assays and
[…]
Illumina 3Q23 and Guidance Ugly, However Post-Grail Profitability Likely to Get Value Investors and Acquirers to Start Taking a Look
11-10-23 (by: Scott Gleason) Illumina has released its financial results for the third quarter with total revenue of $1.12 billion, which remained flat when compared to Q322 and 5% sequentially. Street estimates had called for revenue of $1.13 billion. It’s clear Illumina is facing challenges on a number of fronts
[…]
Strong 3Q23 for Natera; Lots of Momentum with MRD, Potential for Medicare Renasight Coverage, and Improving Reimbursement
11-9-23 (by: Scott Gleason) Natera has reported its financial results for the third quarter with total revenues of $268.3 million, an increase of approximately 27% compared to $210.6 million in Q3 2022. The company processed 626,000 tests in Q3 representing 21% volume growth. This included total oncology tests of 89,000
[…]
Invitae’s 3Q23 Results Drive Further Concern About Long-Term Viability as Cash Burn Goes Wrong Direction and Revenues Decline
11-9-23 (by: Scott Gleason) Invitae has released its financial results for the third quarter with revenue decreasing 9% to $121.2 million compared to $133.5 million in the same period last year. Management stated that the reduction is attributable to exited businesses and geographies and after adjusting for these changes revenue
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SBRT Data Presented at ASTRO Shows High Efficacy in Localized Kidney Cancer; Could Become First Line Treatment if it Demonstrates Superiority Versus Surgery
11-9-23 (by: Scott Gleason) In the realm of kidney cancer treatment, a new clinical trial, FASTRACK II, suggests that stereotactic body radiotherapy (SBRT) is a highly effective option for individuals unable to undergo surgery. The data, presented at the American Society for Radiation Oncology (ASTRO) annual meeting, highlighted SBRT as a
[…]
Oxford Nanopore Announces Strategic Acquisition of Northern Nanopore Instruments to Boost Solid-State Nanopore Development Program
11-9-23 (by: Scott Gleason) Oxford Nanopore Technologies has announced the acquisition of Northern Nanopore Instruments (NNi), a Canadian biotechnology startup specializing in innovative solid-state nanopore fabrication technology. This strategic acquisition is set to enhance Oxford Nanopore’s solid-state nanopore expertise and patent portfolio, underlining the company’s commitment to continuous innovation and
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COMBINEDBrain Launches WGS Study for Children With Neurodevelopmental Disorders; Broad Institute Will Perform Sequencing Using Fabric Genomics Interpretation Software
11-9-23 (by: Scott Gleason) COMBINEDBrain, a non-profit organization dedicated to expediting cures for neurodevelopmental disorders, has unveiled Project FIND-OUT (Fast Infant Neurodevelopmental Diagnosis via Outpatient Testing), a collaborative effort involving non-profit entities, academic institutions, and industry organizations. Project FIND-OUT aims to provide whole genome sequencing (WGS) to infants displaying early
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Owlet Receives FDA Approval For Non-Prescription Dream Sock Significantly Expanding Market
11-9-23 (by Scott Gleason) Owlet has received approval from the U.S. Food and Drug Administration (FDA) for its Dream Sock. The announcement establishes Dream Sock as the first over-the-counter medical pulse oximetry solution for infants, paving the way for advanced digital health technologies in at-home infant care. Dream Sock is
[…]
23andMe Misses in 2Q24 and Losses Widen; Given Cash Concerns, Management Increasingly Focused on Margins with Price Increases, Headcount Reductions, and Planned Lower Ad Spending
11-9-23 (by: Scott Gleason) 23andMe has announced its financial results for the second quarter of fiscal year 2024 with total revenue of $50 million, a 34% decrease from the same period in the prior year. Analysts had been looking for revenue of $56.8 million. Management stated that the decline was
[…]
Ultromics Receives HOPPS Code for EchoGo Heart Failure in Outpatient Setting Following Inpatient Reimbursement Earlier this Year
11-9-23 (by: Scott Gleason) Ultromics has announced that the Centers for Medicare & Medicaid Services (CMS) has revised the assignment of the clinical ambulatory payment classification (APC) for the Healthcare Common Procedure Coding System (HCPCS) code C9786, designating it to APC 5743 with a payment rate of $284.88, effective January
[…]
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