Transcatheter Mitral Valve Repair Devices
Apr 16, 2026
Reach Surgical Announces CE Mark Certification for Innovative iREACH IRIS Stapling System; TOBY Earns FDA Breakthrough Tag for Innovative Urine-Based Cancer Detection Test; DuPont Introduces AmberChrom™ XT SL Resins to Streamline Biopharma Processing; Sectra Strengthens AI Roadmap with Completion of Oxipit Acquisition; KingstronBio Marks First Patient Implant of ProStyle M® in National Multicenter Study; MiRus Starts Recruiting Patients for STAR Trial Evaluating Siegel™ Valve
Reach Surgical Received CE Mark Approval for iREACH IRIS, First Powered Reusable Stapler with Real-Time Firing Curve™ and 90° Articulation On 14 April 2026, Reach Surgical, the surgical solutions division of Genesis MedTech, received CE Mark approval for its next-generation powered stapling platform, iREACH IRIS...
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Apr 09, 2026
Waters Receives FDA Approval for Advanced HPV Self-Collection and Testing Kit; MedCAD Achieves FDA 510(k) Clearance for AccuStride® Tib/Fib Anatomical Solution; Mercy Medical Center Expands IBD Care with Office-Based Intestinal Ultrasound; BD Introduced Next-Generation TIPS Innovation to Enhance Portal Hypertension Care in the European Union; KingstronBio Completes First ProStyle M® Mitral Valve Implant in Confirmatory Trial; MiRus Launches Enrollment for STAR Randomized Study of Siegel™ TAVR System
Waters Announced the FDA Clearance of the Most Comprehensive At-Home Cervical Cancer Screening Tool, the Onclarity HPV Self-Collection Kit and FDA-Approved HPV Assay On 08 April 2026, Waters Corporation announced that the U.S. Food and Drug Administration had cleared the Onclarity HPV Self-Collection Kit and app...
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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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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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Apr 17, 2025
Edwards’ SAPIEN M3 Becomes First Transfemoral TMVR System to Receive CE Mark; Terumo Neuro Receives FDA Clearance for Carotid Stent System; Microbot Medical Reports Complete Robotic Navigation Success in LIBERTY® System Pivotal Trial; J&J MedTech Marks Milestone with First OTTAVA™ Robotic Surgeries; Baxter Introduces Room-Temperature Hemopatch for Faster Surgical Hemostasis; Merit Medical Introduces the Ventrax™ Delivery System
Edwards' SAPIEN M3 Received CE Mark as the World’s First Transfemoral TMVR System On April 14, 2025, Edwards Lifesciences Corporation announced that its SAPIEN M3 mitral valve replacement system had received CE Mark for the transcatheter treatment of patients with symptomatic (moderate-to-severe or severe)...
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Apr 03, 2025
Abbott Secures CE Mark for Volt™ Pulsed Field Ablation System and Unveils TRILUMINATE™ Trial Data on TriClip™ for Tricuspid Valve Repair; Zimmer Biomet’s RibFix Advantage® Fixation System Earns CE Mark; Teleflex Announces Initial Clinical Data from IDE Study Evaluating Ringer™ PBC in Coronary Perforation Treatment; GE HealthCare Launches Revolution™ Vibe CT, Bringing Unlimited One-Beat Cardiac Imaging and AI Solutions; TELA Bio Launches Larger OviTex® PRS Sizes in the U.S.
Abbott Received CE Mark for Volt™ Pulsed Field Ablation System, Offering New Therapy Option for Heart Rhythm Disorders On March 27, 2025, Abbott announced that it received the CE Mark in Europe for its VoltTM Pulsed Field Ablation (PFA) System, designed to treat patients with atrial fibrillation (AFib). Th...
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Feb 03, 2022
Insulet’s Omnipod 5 Automated Insulin Delivery System; Alivecor’s KardiaMobile Card; BD Board Approved the Spinoff of embecta; Medtronic’s Hugo Surgery Robot; Artivion’s On-X® Mitral Heart Valve PROACT; OmnySense’s Smart Thermometer Clinical Trial
Insulet Received FDA Clearance for its Omnipod® 5 Automated Insulin Delivery System, First Tubeless System with Smartphone Control On January 28, 2022, Insulet Corporation, a market leader in developing tubeless insulin pumps with its product, Omnipod®, received the FDA approval for its Omnipod® 5 Automated Insu...
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