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Final LCDs from MACS Lead To Questions on Coverage for Certain MIGS Procedures for Glaucoma TreatmentHologic Reports Solid 3Q23; Mammography Backlog Driving Strong Capital Equipment SalesSBRT Data Presented at ASTRO Shows High Efficacy in Localized Kidney Cancer; Could Become First Line Treatment if it Demonstrates Superiority Versus SurgeryOwlet Receives FDA Approval For Non-Prescription Dream Sock Significantly Expanding MarketNeuronetics Announces Positive Payer Coverage Changes for NeuroStar Depression Treatment Technology Eliminating Barriers to AdoptionEnovis Reports Strong 3Q23 and Raises Full Year Outlook Based Upon Strong Hip/Knee Growth; Expects to Drive Synergies Accelerate Growth With LimaCorporate DealGE Healthcare and Masimo Partner to Add Oxygen Saturation Measurement to the Portrait Mobile Wearable Monitoring Technology for HospitalsNew AABB Guidelines Recommend More Restrictive Guidelines on Red Blood Cell TransfusionThe Robots are Coming; Johnson & Johnson Plans to Start Surgical Trials on OTTAVA in 2024Zimmer Sees Similar Trend Line to Peers With Elective Procedures Slowing From Early 2023; New CEO Focused on InnovationSI-BONE Reports Strong Growth in 3Q23 Driven by Increased Physician Adoption and Procedure ExpansionEmpatica Receives FDA Approval for Two New Biomarkers on Wearable to Support Clinical ResearchMedicare Creates New $15 Billion Market for Previously Non-Reimbursed Exoskeleton Technologies; Microcap Companies Ekso Bionics and ReWalk Robotics Could Be the Biggest BeneficiariesCerus Reports Solid 3Q23 With Meaningful Progress Towards Cash Flow Breakeven; Pending Catalysts With IFC and Red Cell Technology Provide Exciting 2024 Set-UpEndologix Shares Pooled Analysis at VIVA Showing Novel DETOUR System Results in Positive Outcomes for Severe PAD Patients With Less-Invasive TechniqueCooperCompanies Announces Streamlined Acquisition of Cook Medical Reproductive Health Assets Following FTC Intervention; Despite Smaller Scale Deal to Be Highly Accretive in 2024Gynesonics Raises $67.2 Million to Further Commercialize Innovative Uterine Fibroid Device; Follows Rash of Positive Coverage Decisions for the TechnologyInspireMD Shows Positive Data at VIVA with CGuard Carotid Stent System Demonstrating Low Rate of DSMI at 30 Days Compared to Previous StudiesBeyond Air Study Using UNO Therapy in First Patients Shows Immunostimulatory Response and Low Side Effects; Warrants Further Investigation/DataSmith + Nephew Focuses on Robotic Tool Expansion in Orthopedics/Trauma; Notes Some Elective Procedure Slowing Following the Post COVID-19 Catch UpHaemonetics Beats in the Quarter; Plasma Catchup from Pandemic and Strong Hospital Growth Continue to Drive ResultsInsulet 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 2024Increased Barostim Reimbursement in the HOPPS Causes CVRx Stock to RallyBaxter Announces Largely In-Line 3Q22; Streamlining Portfolio to Focus on Growth With Divestiture of BioPharma Solutions and Planned Spin-Off of Kidney CareAtriCure Reports Solid Growth in 3Q23 on the Heels of New Technology Offerings for Atrial FibrillationStryker Management Very Bullish on Procedures and Capital Purchases Heading into FY24; Likely Right in Short-Term, but Broader Industry Trends Support CautionWhat Stryker and Smith & Nephew Implant Growth Can Tell Us About Elective Procedure Trends; Consistent With Earlier HCA DataTandem Diabetes Care Disappoints in 3Q23 as it Pivots to Mobi and New Offerings in 2024Nevro Corp. Beats Outlook and Raises Forecast but Faces Expanding Competition in High Growth Diabetic Neuropathy IndicationMcKesson Beats in 3Q23, GLP-1 Drives Increased Pharma Segment Revenue and Increased Prescription Technology Solutions Due to Prior Authorization Service DemandMacro Headwinds to Elective Procedures and Declining Profitability Weigh on STAAR in 3Q23Glaukos Reports Solild 3Q23 but Commentary on Physician Behavior Due to Draft MIGS LCDs Weighs on StockInari Medical Reports Solid 3Q23 and Announces Complementary LimFlow Acquisition, but Investors Worry About Dilution and Distraction from Core MarketZimVie’s 3Q23 Better than Tepid Expectations, but Elective Procedure Headwinds in Dental Likely to Worsen and U.S. Spine Competition Unlikely to AbatePenumbra Presents Interim Data From STRIKE-PE Study at VIVA Showing the Indigo Aspiration System Led to Positive Outcomes for Pulmonary Embolism PatientsXēnix Medical Receives FDA Clearance for Innovative SOLACE Sacroiliac Fixation System Using Proprietary NANOACTIV Surface TechnologyYourBio’s TAP Micro Receives CE Marking Joining Tasso+ As Cleared Technologies for Self Blood Collection; Cost and Volume Challenges Remain for Broadscale AdoptionWhat Hospital Capital Equipment Challenges? GE Healthcare Maintains Full Year Growth OutlookMIMEDX Reports Strong 3Q23; With Skin Substitute LCDs in Rear View and EPIEFFECT Launch Company Well Positioned in Fourth QuarterPulmonx Corporation Reports Strong 3Q23 and Increases Full Year Outlook With Japan Launch and AeriSeal Study PendingMovano Health’s Prototype Chip for Evie Ring Achieves FDA-Recognized Accuracy in Blood Pressure Monitoring StudySurmodics Launches New Preside™ Medical Device Coating TechnologyZynex Announces Strategic Alternative Process Aimed at Driving Shareholder ValueNew Study from Implicity Demonstrates The Ability of New Proprietary Algorithm to Reduce Alert Burden During Patient Monitoring for Atrial FibrillationZynex Appears Poised for Momentum Following Sales Force Expansion and New Product LaunchesNovocure Reports Slight 3Q23 Revenue Miss; Focus on Regulatory Submissions Following Successful LUNAR TrialResMed Delivers In-Line 3Q23; Highlights Opportunities in Digital Solutions and New Markets for Forward GrowthEkso Bionics Shows Solid Progress in 3Q23; New CMS Reimbursement Change Could be Game Changer in 2024Merit Reports Strong 3Q23 and Raises Full Year Outlook; Notes CEO Succession Plan Likely to be Announced by Year EndApple Facing Potential Import Ban for Apple Watch Based Upon IP Challenges to Health Features From AliveCor and MasimoExactech Receives Approval for New 3D-Printed Tibial Implants for Small But Fast Growing Ankle Arthroplasty MarketEdwards 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 CycleTissue Products Recall and Facility Closure Weigh on Integra LifeSciences 3Q23 Results; Expected to Be Resolved in Mid-2024Outsource Device Manufacturer Integer Holdings Corporation Reports Strong 3Q23 and Guide; Positive Leading Indicator for Industry Cardiology and Neuromodulation MarketsBoston Scientific Reports Solid 3Q23 on Strong Cardiology Revenue; New Approvals, Acquisitions, and Data Sets Position the Company for Solid Growth AheadSurgical Products Provider CONMED Delivers Solid Performance Despite Allograft Supply DisruptionInspira Technologies Receives Key Priming Patent Supporting the INSPIRA ART500 Respiratory Support DeviceEdwards Lifesciences Reports In-Line 3Q23 But Guides Below Street for 4Q23 Following Strong Data Showing at TCTAbbott’s Espirit BTK System Outperforms Angioplasty in PAD Patients With Chronic Limb-Threatening IschemiaPositive Data for Boston Scientific’s Drug Coated Balloon Presented at TCT Could Support FDA Approval for In-Stent RestenosisAbbott Presents Positive New Data at TCT on Transcatheter Devices for Tricuspid and Mitral Valve RegurgitationFresenius Medical Care Recalls Hemodialysis Machines Due to Potential Exposure to Toxic CompoundsXtant Medical Buys Production Operations for nanOss Products from RTI Surgical Following Product AcquisitionMedtronic Evolut Trial Combined With Partner 3 Data May Be Nail in Coffin for Surgical Aortic Valves; Data Shows Lower Mortality With TAVRPartner 3 Study Showing Long-Term Safety Profile of Transcatheter Aortic Valves Could Lead to Even Further Adoption Over SurgeryGlobus Medical Presents Data From Long-Term Nuvasive Simplify Disc Study Demonstrating Superiority to Anterior Cervical Discectomy Fusion ProceduresBoston Scientific Reports Results From Electronic Health Record Study Showing EKOS Has Lower Adverse Event Rate Compared to Inari’s FlowTriever SystemHCA Earnings Shows Some Softening in Surgical Volumes From Start of YearABK Biomedical Commences Pivotal Study in Hepatocelluar Cancer with First Patient Treated Using Microsphere TechnologyAllergan Aesthetics Reports Positive Phase 3 Trial Results for New Fast Acting Neurotoxin for Face WrinklesButterfly Network Signs Ultrasound Chip Deal With Forest Neurotech to Support Brain Measurement/Modulation Implantable DeviceElekta to Acquire Xoft, a Subsidiary of iCAD, Inc.; Allows iCAD to Focus on Core Imaging Software BusinessMedtronic’s New Aurora EV-ICD Receives FDA Approval; Real World Performance Study Hopes to Show Lower Rates of Venous ComplicationsWearable Ring Maker ŌURA Announces Canadian Retail Launch in Partnership with Best BuyInsulet Corporation Achieves FDA Clearance for Omnipod 5 App for iPhoneCARMAT Reports Seven Aeson Implants Completed in EFICAS Clinical Trial for Its Total Artificial Heart Following Emergency FinancingOlympus Launches Next Generation Endoscopy SystemOrthoPediatrics Launches Pediatric Nailing Platform for Tibial FracturesIntuitive Surgical’s 3Q23 Shows Some Cracks in Capital Equipment Outlook; Procedure Growth Outlook Shows Signs of SofteningProtembis Gets FDA Approval for Cerebral Protection Device IDE; Study Design Could Show Superiority to Boston Scientific’s Sentinel DeviceGE 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 2024Apollo Neuro Launches First Wearable With Subscription Service to Address Sleep Disturbance and Reduce StressAVITA Pre-Announces Accelerating Growth in 3Q23 and Secures $90M Debt Facility Following Recent Expanded Indications for RECELL and RECELL GO Filing DelayNeuroPace Unveils RNS System Enhancements to Improve Care for Epilepsy PatientsAbbott Reports Strong Third-Quarter 2023 Results With Medical Device Sales up 15% Organically, Diagnostics up 6% Excluding COVID-19Henry Schein Completes Acquisition of Shield Medical Expanding Home Care OfferingSight Sciences Announces Strategic Cost Measures as it Awaits Final LCDs on MIGS TechnologyJNJ Reports Strong 3Q23 Results But Global Med-Tech Sales Deaccelerate; Read Throughs for Other CompaniesFisher & Paykel Healthcare Launch New F&P Solo Mask for Sleep ApneaAlphatec Showcases New Technology Offerings at NASS MeetingJohnson & Johnson Receives FDA Approval for New Foot/Ankle Plating SystemFDA Approves Establishment Labs Tissue Expander Technology for Mastectomy PatientsHenry Schein Cybersecurity Incident Disrupts Business Operations; Emblematic of Increased Risks Around Data SecurityData from Neuronetic’s NeuroStar Outcomes Registry Shows Significant Improvements in Remission/Response for Patients That Complete Full Therapy CourseNovocure Presents Data on Patient Tolerability/Quality of Life Data for NSCLC at ESMO from LUNAR TrialGE Healthcare Announces FDA Approval for Allia IGS Pulse for Cardiac Imaging ProceduresBaxter Launches New Software Application Allowing the Capture of Eye Images on a Smart Phone During Opthalmoscope ProceduresAlphatec Holdings Preliminary 3Q23 Revenue; Strong Beat Driven by Continued Adoption of Lateral Access Techniques Leads to Full-Year Guidance RaiseCOSMOS Study Demonstrates Ability of GE HealthCare’s Portrait Mobile Continuous Monitoring Solutions to Reduce Alarm Fatigue in Ward EnvironmentsSight Sciences Announces Results in SAHARA Clinical Trial Comparing TearCare vs. Standard of Care Restasis for Dry Eye DiseaseFDA Approves New Oxygenation Parameter for Masimo Pulse Oximetry PlatformMedacta Study in Shoulder Arthroplasty Further Demonstrates the Potential of Augmented Reality in OrthopedicsEstablishment Labs Presents Clinical Data On Mia Femtech, Minimally Invasive Breast Augmentation Technology; Launches New RFID SensorTough Few Months for Dialysis Company Outset Following FDA Warning Letter, Novo Nordisk GLP-1 Data, and Now Pre-Released Revenue MissGetinge Acquires Healthmark Industries Strengthening Global Position in Sterile Reprocessing MarketDaVita Releases Statement Following Stock Sell-Off on Novo Nordisk’s GLP-1 Study AnnouncementGE HealthCare Signs $44 Million Contract with BARDA to Develop AI-Enhanced POCUS Technology for Mass Casualty EventsOrthofix Medical Inc. Launches OsteoCove™ Synthetic Bone GraftBraun Launches New Introcan Safety® 2 IV Catheter to Prevent Needlestick Injuries and Blood ExposureBoston Scientific’s Neuromodulation System Receive FDA Approval for Treating Diabetic Peripheral Neuropathy; Joins Nevro, Medtronic, and Abbott in Increasingly Crowded MarketPulmonx Announces CFO Transition; Pre-Releases Above Consensus Revenue for 3Q23Masimo Gets CE Mark for New Hemodynamic Monitoring Module; Facilitates Access to Real Time Data on a Single DisplayOrthoPediatrics Launches New Functional Brace for Pediatric Femur Fracture; Data Shows Cost Benefits, Ability to Prevent General AnesthesiaGE Healthcare and SOFIE Biosciences Partner on FAP Radiopharmaceuticals Shown to Be Highly Prognostic in Cancer StudiesAllurion Completes AUDACITY Trial Enrollment for Highly Non-Invasive Weight Loss BalloonSilk Road Medical Pre-Announces Significant Revenue Miss; CEO RetirementTeleflex Completes the Acquisition of Acquisition of Palette Life SciencesFDA Issues Warning Letter to JNJ Subsidiary Abiomed Citing Issues with Impella Heart PumpAdvaMed Announces New Digital Health Tech DivisionEndotronix Announces New IDE for Class II Heart Failure Patients and Positive Early Data in PROACTIVE-HF Study for Class III PatientsHologic Partners With AAGL and Inovus to Provide Training Solutions to New OB-GYNsAlcon Introduces TOTAL30 Multifocal Contact Lenses to Address PresbyopiaHaemonetics Corporation to Acquire OpSens, Inc., Signals Further Move into Interventional CardiologyButterfly Network Introduces New Education Support ToolsBest Buy to Sell Dexcom G7 CGM System OnlineMindray Launches New Lightweight Wireless Ultrasound at ACEPMulticenter Study Using Sonex Health Technology Cites Benefits of Ultrasound-Guided Carpal Tunnel ReleaseGE Healthcare Integrates Caption Guidance Heart Failure AI Technology Into Ultrasound SolutionsGE Healthcare and University Hospitals Sign 10-Year Strategic PartnershipFresenius Kabi Receives Warning Letter from FDA on Fenwal Blood ProductsNext-Generation Dexcom G7 Continuous Glucose Monitoring System Now Available in CanadaAccuray’s Tomo® C Radiation Treatment Delivery System Approved by China’s NMPAAirLife Completes Acquisition of Avanos Medical’s Respiratory Health BusinessVapotherm Study Utilizes Computational Fluid Dynamics to Demonstrate High Velocity Therapy Leads to Better Clearance of CO2 from the AirwayButterfly Network and Razom Partner to Expand Access to Butterly iQ+ Ultrasound Technology in UkraineNanox Partners with Varex Imaging on New Manufacturing and Supply AgreementBiotricity Announces Key Patent Filing for Biotres Electrocardiogram (ECG) Wearable DeviceSight Sciences Announces Significant Head-to-Head Study on MIGS Technologies for Glaucoma PatientsAvita Medical Announces FDA Request for Additional Information on RECELL GO; Timeline for Approval Moves To Mid-2024Anumana Receives FDA 510k Approval for New AI Powered Heart Failure Diagnosis TechnologyCordis Completes Acquisition of MedAlliance in Deal Worth up to $1.135 Billion; SELUTION DeNovo Trial Could Have Big Implications for PCI MarketFollowing Lobbying by Radiologist Societies, CMS Allows for Billing of Multiple Cardiac MRI ProceduresDexcom Presents Long-Term Data from the COMISAIR Study at EASD Demonstrating Positive Outcomes for Diabetes Patients Using CGMAccuray Introduces Cenos™ Online Adaptive Therapy Option at ASTRO 2023Carlyle Group Rumored To Be in Negotiations to Buy Medtronic’s Patient Monitoring and Respiratory Business UnitsSiemens Healthineers Unveil New 3-D Mammography System with High-Speed Imaging TechnologyOrganogenesis Applauds Decision to Withdraw Medicare Local Coverage Determinations; Decision Eliminates Reimbursement Uncertainty for Company’s Wound Care ProductsNyxoah Partners with ResMed Germany to Advance Obstructive Sleep Apnea (OSA) Awareness and TherapyNanox.AI’s HealthCCSng Reveals Hidden Cardiovascular Risks in Routine CT ScansGalen Robotics Receives First FDA Approval for Robotic ENT Surgical Robot; Announces Series B Funding RoundGN Hearing and Beltone Announce Launches of Next Generation Hearing Aids4WEB Medical Expands Orthopedic Implant Portfolio with New FDA Approval; Moves Closer to Comprehensive Cervical SolutionBeacon Receives FDA Approval for Dreem 3S; Facilitates Collection of High Quality Sleep Data in the Home SettingBoston Scientific To Acquire Relievant Medsystems for $850 Million; Gains Access to Lower Back Pain TechnologyCardinal Health Launches Kangaroo OMNI™ Enteral Feeding PumpDexcom Canada and RxFood Partner to Improve Diabetes Management; RxFood App Shown To Improve Diabetes Outcomes in Clinical StudiesExo Unveils New Handheld Ultrasound Device for Point-of-Care ImagingiRhythm Unveils Next Generation Zio Monitor and Long-Term Continuous Monitoring ServiceFDA Issues Final Guidance Document on Cybersecurity Requirements for Premarket Device SubmissionsChanges for Exoskeleton Reimbursement Under Home Health Prospective Payment System Could Expand Access to TechnologiesSenseonics Completes 365-Day ENHANCE Pivotal Clinical Study, Moves Closer to One-Year Eversense Implantable Sensor ApprovalCardiosense Begins Enrollment in Nationwide Heart Failure StudyNICE Conditionally Recommends AliveCor’s KardiaMobile for Measuring Cardiac QT Intervals in Adults Taking Antipsychotic MedicationMiMedx Group Launches EPIEFFECT for Hard-to-Heal WoundsFDA Approval for BACKBEAT Study A Major Potential Win for Orchestra BioMed and Medtronic in U.S. Pacemaker MarketZimVie Receives Approval For Hybrid CDA and ACDF Study Using Mobi-C Cervical Disk ProsthesisEnovis to Acquire Global Orthopedic Company LimaCorporateProfound Medical Receives 510(k) Clearance for Thermal Boost AI Module for Use With TULSA PRO Prostate Cancer Ablation TechnologyFDA’s CDRH Division Releases Draft Strategic Plan on International Regulatory Harmonization to Lower Redundancy and Reduce Burden on Device ManufacturersAvita Medical Wins Best Product Award for Second Straight Year at American Association for the Surgery of Trauma Meeting with RECELL Spray-On Skin CellsCARMAT Reports its First Half 2023 Results and Provides a Strategic Update on Fully Artificial Heart ProgressVapotherm Study Demonstrates Better Outcomes for Pediatric Asthma Patients Treated with High-Velocity TherapyMedtronic Receives CE Mark For New Simplera Continuous Glucose Monitoring SystemInsightec Receives Humana Coverage for Focused Ultrasound Treatment in Essential TremorNew State Biomarker Legislation Advocated for by the Cancer Action Network Could Be a Game Changer for Expanding Commercial and Medicaid Access for Advanced DiagnosticsKaiser 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 ImplantsChanges in European In-Vitro Diagnostic Device Regulation Will Begin to Impact IVD Manufacturers; New Regulation Structure Will Increase Cost and Evidence Burden to Enter MarketInternet 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 SystemExagen Inc. and Johns Hopkins University Partner to Develop Biomarkers Tests Lupus Nephritis ManagementAdaptive Biotechnologies To Conduct Strategic Review Focused on Shareholder Value Following Disappointing 3Q23Hologic Reports Solid 3Q23; Mammography Backlog Driving Strong Capital Equipment SalesStrong 3Q23 for Natera; Lots of Momentum with MRD, Potential for Medicare Renasight Coverage, and Improving ReimbursementInvitae’s 3Q23 Results Drive Further Concern About Long-Term Viability as Cash Burn Goes Wrong Direction and Revenues DeclineCOMBINEDBrain Launches WGS Study for Children With Neurodevelopmental Disorders; Broad Institute Will Perform Sequencing Using Fabric Genomics Interpretation Software23andMe Misses in 2Q24 and Losses Widen; Given Cash Concerns, Management Increasingly Focused on Margins with Price Increases, Headcount Reductions, and Planned Lower Ad SpendingMedicare Recommends Crosswalking 2nd Generation OvaWatch Test from Aspira Labs to Original Ova1 RateOraSure Beats Expectations in 3Q23; Investors Focus on Core Growth and Post InteliSwab Growth DriversAdaptive Announces Multi-Year Partnership With BeiGene to Assess MRD With clonoSEQ in Blood Cancer TrialsNatera’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 OutcomesHelix Announces Another Major Population Genomics Partnership With Cone HealthNeogenomics Delivers Strong 3Q23 With Profitable Growth; RaDaR MRD Test Currently Undergoing Three Coverage Evaluations from MolDxInvitae Announces Sensitivity and Workflow Enhancements to its MRD TestClinical Volume Growth Slows Sequentially in 3Q23 for Guardant Health; Next Generation Colon Test Data Could Be Interesting if Validated in Large Study CohortMyriad Shows Significant Progress With Evident Share Gains in 3Q23; Reimbursement Changes Could Put Company on Course Back to Profitability When Combined With Expense Control23andMe Makes Pivot to Exome Sequencing With New Offering; Cost Changes in WGS Could Provide a Renaissance for the Company’s Business Model Over TimeCastle Bioscience Delivers Strong Volume Growth in 3Q23 and Makes Major Progress on ProfitabilityAbbott Joins Crowded HPV Field With FDA Approval of High-Throughput Molecular TestNatera’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 MarketQuidelOrtho Outperforms on Respiratory Revenue; Profitability Progress a Positive Despite COVID-19 HeadwindsExact 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 ProfitabilityIQVIA Lowers 2023 Outlook and Provides Preliminary Guide for 2024 Calling for Mid-Single-Digit GrowthAgendia’s MammaPrint Test Will be Used to Risk Stratify Patients for NCI Neoadjuvant Immunotherapy Breast Cancer TrialGuardant Health Tests to Become Available on OncoEMR Platform From Flatiron Health Used by 2,000 Oncologists23andMe Unveils Health Action Plan Digital Tool; Provides Added Customer Feature and Increases Information in Proprietary Genomic DatabaseQIAGEN Weathers Macro Storm Better Than Most; QuantiFERON TB Driving Strong Diagnostic GrowthGeneDx Makes Cash Burn Progress in 3Q23 With Goal of Profitability by 2025, However, 4Q Guidance Implies Step BackwardsRevvity Faces Biopharma Challenges, COVID-19 Headwinds in 3Q23Digital Pathology Solutions Provider Paige Receives FDA Grants Breakthrough Device Designation to Lymph Node Detection Software in Breast Cancer23andMe and GSK Extend Drug Development Collaboration for Five YearsFoundation Medicine Joins NCI’s ComboMATCH Initiative to Explore New Combination Therapies for CancerLabcorp Sees Strong Organic Growth From Hospital Outsourcing Deals Overcoming COVID-19 HeadwindsPersonalis Announced Early Access Launch of NeXT Personal Dx MRD Test With Focus on Lung Cancer, Breast Cancer, and Immunotherapy ResponseQIAGEN and Myriad Announce CDx Collaboration Focused on Kitting Advanced DiagnosticsC2N Diagnostics Licenses and Introduces Novel Fluid Biomarker for Alzheimer’s DiseaseICON Follows in Medpace Holdings Footsteps With Strong Booking Trends; Supports Continued Strength in Pharma ResearchAspira Women’s Health Study Shows Combining miRNA and Protein Biomarkers Improves Diagnostic Accuracy of Ovarian Cancer TestMetabolon Partners With Genomics England to Provide Metabolomic Data on 7,000 Patients From 100,000 Genomes Project to Find Rare Disease BiomarkersMindray Launches Two New Cardiac Biomarker Tests for Myocardial Infarction and Heart FailureBostonGene Partners With Exigent Research on Clinical Utility Study for the Tumor Portrait TestMeMed Gets BARDA Contract for Novel Test to Differentiate Bacterial and Viral InfectionsInvitae Releases Study Highlighting Unknown Variant Rates in Large Genetic PanelsProstatype Interim Analysis Demonstrates Ability to Alter Patient Management and Predict Disease ProgressionCaris Signs Research Collaboration with mRNA Leader Moderna, Now Has Over 70 Biopharma PartnershipsQuanterix Enhances Alzheimer’s Offering With License to Johnson & Johnson’s p-Tau 217 AntibodiesQuest Reports Continued Strong Core Requisition Growth in 3Q23 and Solidifies Payer Contracts; LDT Regulation and PAMA Reform Remain UncertaintiesUSC Researchers Develop New Accurate Blood Test for Assessing Ovarian Cancer in Patients With Adnexal MassesDanaher 3Q23 Results Show Continued Headwinds From Bioprocessing, China, and COVID-19; Management Believes Inventory Draw Downs Will Lead to Improved Trends in 2024Neogenomics Launches Comprehensive Genomic Profiling Test for Hematomalignancies; Could Be a Strong Compliment to Existing Anatomic Pathology FranchiseMedpace Holdings, Inc. Posts Strong Q3 2023 Results and Guides Above Street for 2024; Strong Read-Through on Biopharma InvestmentData from GALAXY Study Shows Ability of Natera to Predict Outcomes and Benefit of Adjuvant Chemotherapy in Resectable Colorectal CancerPersonalis Data from TRACERx for MRD Test Appears on Par With Market Leader NateraGenoscopy Data Good, But Tough Hill to Climb Commercially Given Next Generation ColoGuard Test is More AccurateBLUE-C Trial Will Make It Even More Challenging for Imitators; Extends Exact Sciences’ Lead in Non-Invasive Colorectal Cancer DetectionFoundation Medicine Agrees to Tech Transfer with Sequanta Technologies to Support Clinical Trials for Oncology Medicines in ChinaUNH Arbitration Rulings on Unpaid Claims Could Have Significant Ramifications for Insurance Companies and Service ProvidersFoundation Medicine Announces Positive Data from CUPISCO Study in Difficult to Treat CUP Patients Will be Presented at ESMOThermo Fisher Scientific and Boehringer Ingelheim Partner to Advance Precision Cancer TherapiesMicroba Life Sciences Acquires Invivo in Deal Valued at up to A$21.5 Million; Strengthens Position in Microbiome Testing MarketPhenomix’s MyPhenome Hungry Brain Test Shows Ability to Predict Response to Weight Loss Drug QsymiaVolitionRx’s Nu.Q® NETs Test Shows Promise in Study as Sepsis Severity BiomarkerAncestry Launches Genetic Traits Feature Allowing Customers to Determine 43 Inherited Parental CharacteristicsNew CRISPR Diagnostic Company VedaBio Announces $40 Million Funding & Platform Launch; Unclear Whether Technology Uses Existing Intellectual PropertySOPHiA GENETICS Partners with Memorial Sloan Kettering and AstraZeneca To Broaden Access to Advanced Cancer TestsTelo 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-19AMP Clinical Practice Committee Working Group on Liquid Biopsy Publishes Recommendations to Standardize Industry PracticesEurobio Introduces New Rapid Sequence Based Typing Test for HLA Testing Using Oxford Nanopore Long-Read TechnologyRevvity Expands Newborn Screening Mass Spectrometry Offering Through SCIEX PartnershipHCA Healthcare Partners with GRAIL to Offer Galleri Liquid Biopsy TestThermo Fisher Pays Big Multiple for Olink; Deal Expected to Accretive Year One Based on Substantial Cost/Revenue SynergiesProPhase Labs Announces Rapid Manufacturing Growth at CDMO Subsidiary Given Demand for Cold LozengesbioMérieux Receives CE-Marking for Blood Test for Traumatic Brain InjuryFollowing Failed Strategic Alternative Process; Biocept, Inc. Files for Chapter 7 Bankruptcy, Announces CEO/Board ResignationCharles River Laboratories Expands Access to Pediatric PDX Collection Following FDA/EMA Regulations Mandating Pediatric Testing for New Oncology DrugsInterVenn Biosciences Announces New Publication On Colorectal Cancer Multivariable Classifier Model; Aims to Launch Colon Cancer LDT in 2023Biocartis and APIS Expand Partnership in Breast Cancer with ESR1 Test Added to ASCO Guidelines in MayNew Naveris Studies Show Potential for Viral DNA as a MRD Marker in Oropharyngeal CancersT2 Biosystems Pre-Releases 3Q23 Results; Announces Additional FDA Submission for Sepsis TestInvitae Study Furthers Argument Supporting Hereditary Cancer Testing for all Breast Cancer PatientsFoundation Medicine Receives 2nd CDx Indication of the Week With FDA Approval for BRAF V600E mutations in Pfizer Combination Therapy for NSCLCCardio Diagnostic Holdings Announces New Lab for Proprietary Heart Disease Tests; Focused on Cost ReductionVeracyte Studies at CHEST Demonstrate Envisia’s Ability to Aid in Diagnosis of Interstitial Lung DiseaseEpigenomics AG Finalizes Asset Acquisition Agreement with New Day Diagnostics; Companies to Develop Next Generation Colon Cancer Blood TestFibronostics and Stone Diagnostics Partner to Advance Non-Invasive Liver Disease AssessmentClinical Microbiomics A/S and CosmosID Inc. Merge to Create the Global Leader in Microbiome Research ServicesStudy Demonstrates Pathnostics Guidance UTI Test Lowers Antibiotic Use and Hospitalizations in Complex UTI CasesNew Report from NCI Highlights Impact of COVID-19 on Rates of Cancer DiagnosisQuidel Pre-Releases 3Q23 Revenue; Strong Respiratory Revenue a Positive Read-Through for Other COVID-19 Test ManufacturersClass Action Complaint Against 23andMe, Inc. Filed in California District Court Accuses Company of Data NegligenceGE Healthcare and SOFIE Biosciences Partner on FAP Radiopharmaceuticals Shown to Be Highly Prognostic in Cancer StudiesSYNLAB Launches New Test to Differentiate Bipolar Disorder and Depression; Clinical Validation Shows High Accuracy Using Novel RNA BiomarkersLabcorp Launches New Blood Test for Early Alzheimer’s Detection; Follows Trend in Biomarker Development and Testing Following Leqembi ApprovalFujirebio and Sysmex Announce Bolstered Global Immunoassay Partnership; Deal Will Look to Leverage Combined StrengthsKarius Study Demonstrates the Ability for NGS Technology to Better Detect/Treat Pneumonia Pathogens in Immunocompromised PatientsTecan Sues QIAGEN and Invitae Over Next Generation Sequencing Sample Preparation PatentsAdvaMed Announces New Digital Health Tech DivisionFoundation One Announces FDA Approval for Companion Diagnostic Indication for Retevmo in Cancers With Rare RET Gene FusionsFoundation Medicine and Natera Launch Full Commercial Launch of FoundationOneTracker Utilizing Signatera for Treatment Response MonitoringExact Sciences to Release Full BLUE-C Study Results at ACGEU Regulators Rumored to Be on the Cusp of Ordering Illumina to Sell Grail23andMe Investigates Unauthorized Access to Customer AccountsNeway and Quest Diagnostics Partner to Improve Dialysis Patient CareRenalytix Receives Patents on Foundational Biomarkers for the KidneyIntelX.dkd TestKDx Diagnostics Issued Patents for Keratin 17 Biomarker in Bladder CancerA Deeper Dive Into Grail PATHFINDER Study Highlights Key Clinical Challenges; Unlikely to Be the Path to Broad Adoption and Insurance CoverageEntroGen 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 ConsolidationQIAGEN Launches QuantiFERON-EBV RUO Assay to Advance Research on Epstein-Barr Virus Immune ResponseCSPI Sues EpicGenetics Based Upon Claims of False and Misleading Statements on Fibromyalgia TestA New Study from Metabolomic Diagnostics Demonstrates the Potential for Blood Biomarkers to Improve Preeclampsia Risk Stratification in Pregnant WomenCastle Biosciences’ Study on DecisionDx-Melanoma Tool Demonstrates Ability to Predict Which Patients Should Receive Sentinel Node BiopsyNatera Study Demonstrates Ability of Signatera To Guide Clinical Decision Making in Unresectable NSCLC PatientsCue Health Study Shows High Correlation With POC COVID-19 Test and Laboratory PCREurofins Expands CDMO Capabilities in North America with New Canadian FacilityASCO Issues New Recommendations Aimed to Address Ovarian Toxicity in Cancer Clinical TrialsSerimmune Study Identifies Significant Biological Distinctions Associated with Long COVID-19Standard BioTools and SomaLogic Announce Merger; 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Boston Scientific Reports Solid 3Q23 on Strong Cardiology Revenue; New Approvals, Acquisitions, and Data Sets Position the Company for Solid Growth Ahead

Boston Scientific Corporation reported strong results for the third quarter of 2023. The company achieved net sales of $3.527 billion during the quarter, marking an 11.2 percent increase compared to the prior year and exceeding consensus forecasts of $3.47 billion. The results also exceeded the company’s previous guidance.

The company’s MedSurg segment reported net sales growth of 10.6 percent on a reported basis and 9.4 percent on an organic basis compared to the previous year. The company’s Cardiovascular segment had especially strong growth, with net sales increasing by 11.6 percent on a reported basis and 10.6 percent on an organic basis when compared to the same quarter last year. From a geographic standpoint, the U.S. grew at 8.5%, EMEA grew at 14.7%, Asia-Pacific grew at 14.8%, and Latin America grew at 22.0%.

During the quarter Boston Scientific had several key data presentations, including significant progress in electrophysiology reporting 12 month results from the ADVENT Trial for its new pulse field ablation catheter showing non-inferiority to standard of care therapies. Today, Boston Scientific has a relatively small share in atrial fibrillation treatments compared to market leaders Johnson and Johnson and Abbott, but is poised along with Medtronic to be one of the first companies to introduce the new pulse field ablation catheter technology in the United States. Management noted that electrophysiology grew 33% OUS where these products are already approved, well above market rates. The company also presented data at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium demonstrated the statistical superiority of the AGENT™ Drug Coated Balloon over uncoated balloon angioplasty for patients with in-stent restenosis. at TCT the company also showed significantly lower major bleeding rates in patients treated with the EKOS™ Endovascular System compared to the Inari FlowTriever® System in the REAL-PE study.

During the quarter the company received a number of key regulatory approvals for cardiology products. Boston Scientific announced the U.S. FDA approval of the latest-generation WATCHMAN FLX™ Pro for left atrial appendage closure for stroke prevention. The device is designed to enhance device placement and reduce device-related thrombus post-implant and extends treatment options to a broader range of patient anatomies. The company also received approval from the U.S. Food and Drug Administration (FDA) for the POLARx™ Cryoablation System, which is used to treat patients with paroxysmal atrial fibrillation (AF). Furthermore, the U.S. FDA cleared Boston Scientific’s next-generation LUX-Dx II/II+™ ICM System, offering long-term monitoring of arrhythmias for up to three years. Boston Scientific received CE Mark, U.S. FDA clearance, and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval for the AVVIGO™+ Multi-Modality Guidance System. This advanced technology provides high-quality intravascular ultrasound (IVUS) imaging and physiologic assessment of coronary vessels and lesions. Boston Scientific also received U.S. FDA approval for an expanded indication of the AXIOS™ Stent and Electrocautery-Enhanced Delivery System. This development allows for the endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery.

In neurmodulation, the company announced the expanded indication of the WaveWriter Alpha™ Spinal Cord Stimulator (SCS) Systems for the treatment of painful diabetic peripheral neuropathy (DPN), one of the largest market indications for neuromodulation. Boston Scientific also announced an agreement to acquire Relievant Medsystems for its pain business, a medical technology company that has developed the Intracept® Intraosseous Nerve Ablation System for vertebrogenic pain, subject to customary closing conditions.

From a profitability perspective, 3Q23 EPS were $0.50 versus consensus forecasts of $0.48 and above the company’s guidance range. The company guided to top line growth of 9-11% in the fourth quarter, or 8-10% on an organic basis and adjusted EPS of $0.49 to $0.52. Management recently guided to three year growth of 8-10% with 150 basis points of operating margin expansion over the three year period at its analyst day.

Mike Mahoney, Chairman and Chief Executive Officer of Boston Scientific, expressed his satisfaction with the company’s strong performance in the third quarter. He attributed the success to the dedicated efforts of the global team and the company’s differentiated medical technologies. As Boston Scientific continues its commitment to improving patient care, the achievements of the quarter underscore the company’s category leadership strategy, robust pipeline of innovations, and consistent execution.

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