Medical Devices Market
Mar 05, 2026
Abbott’s New CardioMEMS™ Remote Monitoring Reader Gains FDA Approval; Mobia Medical and Sanford Health Secure FDA Approval for Vivistim Stroke Therapy; Johnson & Johnson Introduces Cereglide™ 42, Cereglide™ 57, and Innerglide™ 7 to Strengthen Catheter Portfolio; Baird Medical Advances Worldwide Registration of AI-Based Surgical Technology; THINK Surgical Achieves First Clinical Use of the TMINI Miniature Robotic System Paired With the Stryker Triathlon Knee System; Monteris Medical Reports Study Linking NeuroBlate® Laser Ablation to Stronger Immunotherapy Response in Recurrent High-Grade Brain Tumors
Abbott’s Next‑Generation Cardiomems™ Remote Heart Failure Monitoring Reader Received FDA Approval to Enhance Patient Experience and Help Detect Disease Progression On 27 February 2026, Abbott announced that the U.S. Food and Drug Administration (FDA) had approved the company’s CardioMEMS™ HERO device, a ne...
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Feb 26, 2026
Galderma Secures Triple Approval for Its New Cutting-Edge Restylane® Syringe Across the European Union, United States, and Canada; 4WEB Medical Secures FDA 510(k) Clearance for New SI Joint Truss System; Medtronic Debuts MiniMed Go Smart Insulin-Delivery System Featuring Simplera Sensor in the EMEA Region; Olympus Expands Labeling to Include Pediatric Use for Two Single-Use Bronchoscopes; Neurent Medical Reports Positive Randomized Controlled Trial Outcomes for the NEUROMARK® System; Envoy Medical Approaches Final Enrollment Phase for Its Fully Implanted Acclaim Cochlear Implant Trial
Galderma Announced Triple Approval of new state-of-the-art Restylane® Syringe in the EU, the U.S., and Canada, Reaffirming the Company’s Position at the Forefront of Injectable Aesthetics On February 25, 2026, Galderma announced that regulatory authorities in the EU, the U.S., and Canada had approved a new...
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Feb 19, 2026
Medtronic Wins FDA Green Light for Stealth AXiS; Retia Medical Secures FDA 510(k) Clearance for Argos Infinity; Danaher Announces Plan to Acquire Masimo Corporation; Dynarex Introduces New Advanced Negative Pressure Therapy Device; Valcare Medical Reports First U.S. Transseptal AMEND™ Implant in Early Feasibility Study; Envoy Medical Reports Enrollment Nearly Complete for Acclaim Cochlear Implant Pivotal Trial
Medtronic Received FDA Clearance for Stealth AXiS™ Surgical System, First Integrated Planning, Navigation and Robotics Platform for Spine Surgery On February 13, 2026, Medtronic, a global leader in healthcare technology, announced U.S. Food and Drug Administration (FDA) clearance of the Stealth AXiS™ surgical sy...
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Feb 12, 2026
Hologic Gains FDA Clearance for Aptima® HPV Assay as Primary Screening Tool; ZOLL Zenix Monitor/Defibrillator Achieves MDR Approval; Labcorp Unveils FDA-Cleared Blood Test for Alzheimer’s Screening; P&F SecureD EU MDR CE Mark Approval for the TricValve® System; Valcare Medical Performs First U.S. Transseptal AMEND™ Implant as Part of Early Feasibility Study; Hyperfine Unveils New Clinical Results Showing Improved Stroke Detection with the Swoop® System
Hologic Received FDA Approval for Aptima® HPV Assay Primary Screening Option, Expanding Cervical Health Portfolio On February 04, 2026, Hologic, Inc. announced that its Aptima® HPV Assay had received FDA approval for clinician-collected HPV primary screening. The test, which was the only FDA-approved mRNA-...
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Feb 05, 2026
GE HealthCare Secures FDA 510(k) Clearance and CE Mark for Allia Moveo, Completing First Global Installation; China NMPA Approves Promega’s MSI Test as a Companion Diagnostic for KEYTRUDA; Oracle Life Sciences AI Data Platform Unifies Data and Agentic Intelligence to Accelerate Breakthroughs and Boost Commercial Outcomes; Quest Diagnostics Launches New Blood Test for Detecting Minimal Residual Myeloma; RevBio Secures FDA Clearance to Begin Pivotal Study of Cranial Bone Glue; Hyperfine Reports Breakthrough Clinical Findings on Swoop® System’s Increased Sensitivity in Stroke Detection
GE HealthCare Announced the U.S. FDA 510(k) Clearance and CE Mark for Allia Moveo and marks first Global Installation, Advancing Precision Care in the Interventional Suite On February 02, 2026, GE HealthCare announced that Allia™ Moveo received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark...
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Jan 29, 2026
Seno Medical Secures EU MDR CE Mark for Next-Generation Imagio® Imaging System; Spine Innovation Announces FDA 510(k) Clearance of LOGIC™ Titanium Expandable Interbody System; Laborie Adds JADA® System to Obstetrics Portfolio for Rapid PPH Control; Olympus Introduces SecureFlex™ Single-Use Fine Needle Biopsy Device in the U.S.; Kardium Publishes PULSAR Pivotal Trial Findings in JACC; Myra Vision Begins U.S. ADAPT Glaucoma Study, Treating First Participant
Seno Medical’s Next-Generation Imagio® Imaging System Obtained European Union (EU) Medical Device Regulation (MDR) CE Mark Certification On January 26, 2026, Seno Medical received CE Mark certification for its next-generation Imagio® Imaging System, Model 9100, confirming that the device met the stringent ...
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Jan 22, 2026
Sonomotion Secures FDA Clearance for Break Wave™ Lithotripsy System; Aidoc Earns FDA Clearance for Comprehensive AI Foundation Model in Healthcare; BD and Ypsomed Deepen Partnership to Serve Expanding Biologics Market; Omnia Medical Launches FDA-Approved PsiF DNA™ System to Market; Kardium Publishes PULSAR Pivotal Trial Findings in JACC; NEURO PMR Data Validates Hyperfine’s Diagnostic Precision and Patient-Centered Care
Sonomotion Announced FDA Clearance for its Break Wave™ Lithotripsy Device for Treatment of Kidney Stones On January 21, 2026, SonoMotion, a venture-backed medical device company focused on developing non-invasive solutions for kidney stone treatment, announced that it had received U.S. Food and Drug Admini...
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Jan 15, 2026
Medtronic Diabetes Secures FDA Clearance for MiniMed Go™ Smart MDI Platform; Neurolief Achieves FDA PMA Approval for Novel At-Home Brain Stimulation Therapy for Depression; Haemonetics Completes Acquisition of Vivasure Medical Limited; Boston Scientific Enters Agreement to Acquire Valencia Technologies; Butterfly Medical Completes Pivotal Trial for Minimally Invasive BPH Therapy; TYBR Health Announces First U.S. Clinical Use of the B3 GEL™ System
Medtronic Diabetes Announced FDA Clearance for MiniMed Go™ Smart MDI System Featuring Instinct Sensor Made by Abbott On January 12, 2026, Medtronic, a global leader in healthcare technology, announced that it had received U.S. Food and Drug Administration (FDA) 510(k) clearance for its MiniMed Go™ app. The MiniM...
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Jan 08, 2026
Gore Secures FDA Approval for Its First Deep Venous Stent for IVC and Iliofemoral Veins; Stereotaxis Secures FDA Approval for MAGiC Ablation Catheter; Stimlabs® LLC Announces FDA 510(k) Clearance and Launch of Allacor P™ for Wound Care; CorePlus and AIxMED Join Forces to Deliver AI-Powered Bladder Cancer Detection with Complete QC; Interim Clinical Outcomes at Six Months from the SPARTAN Study Evaluating the TransLoc 3D™ System; TYBR Health Reports First U.S. Clinical Use of the B3 GEL™ System
Gore Gained FDA Approval for First Deep Venous Stent Indicated for the IVC and Iliofemoral Veins On January 06, 2026, W. L. Gore & Associates’ medical business (Gore) announced that it had received FDA approval for the GORE® VIABAHN® FORTEGRA Venous Stent, formerly known as the GORE® VIAFORT Vascular S...
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Jan 01, 2026
Edwards Lifesciences Receives FDA Approval for SAPIEN M3 Mitral Valve System; StimLabs Secures FDA Clearance for Theracor™, an Umbilical Cord–Derived Medical Device Sheet; NGD Infection Prevention Installs NGD200 System at the Middle East’s Largest Medical Center; Overture Orthopaedics Reaches $1.0M Sales Milestone for OvertureTi® Knee Resurfacing System; Envoy Medical Achieves Enrollment Milestone in Pivotal Trial of Fully Implanted Acclaim® Cochlear Implant; Galaxy Therapeutics Announces Completion of Patient Enrollment in Pivotal SEAL-IT IDE Trial
FDA Approves Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy On December 23, 2025, Edwards Lifesciences announced that its SAPIEN M3 mitral valve replacement system, the first transcatheter therapy using a transseptal approach, received approval from the...
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