Final LCDs from MACS Lead To Questions on Coverage for Certain MIGS Procedures for Glaucoma Treatment

Medical Devices

Diagnostics/Labs/Biomarkers

Life Science Tools

Healthcare IT/Disease Mgmt./Telemedicine

Animal Health/Food Safety/Dental

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?

Final LCDs from MACS Lead To Questions on Coverage for Certain MIGS Procedures for Glaucoma Treatment

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