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Tue, Jul 29, 2025

510(k)

Home » Topics » Regulatory » 510(k)
  • Tavipilot software 7 16
    July 16, 2025
    By Shani Alexander

    Caranx Medical gets FDA nod for TAVR software Tavipilot Soft

    Caranx Medical SAS secured clearance from the U.S. FDA for Tavipilot Soft, its AI-powered software which provides real-time intraoperative guidance during transcatheter heart valve replacement (TAVR) procedures. The software, which tracks anatomical and instrumental landmarks in real-time to enable precise and accurate heart valve positioning and delivery, will allow a broader number of cardiologists to perform this complex procedure.
  • Synchrony libairty system 7 15
    July 15, 2025
    By Shani Alexander

    Synchrony receives FDA OK for Libairty airway clearance system

    Synchrony Medical Ltd. received the greenlight from the U.S. FDA for its Libairty airway clearance system which is expected to transform the lives of people with chronic lung diseases. The company is now looking to raise $5 million in series A funding to support the launch of the product in the U.S. later this year.
  • Farawave system 21oct24
    July 7, 2025
    By Annette Boyle

    FDA greenlights Boston Sci’s Farapulse for persistent AF

    Boston Scientific Corp. gained a second U.S. FDA approval for its Farapulse pulsed field ablation catheter, expanding its use into drug-refractory, symptomatic persistent atrial fibrillation (AF) in addition to its existing approval for paroxysmal AF. The expanded indication marks the first of several regulatory approvals the company expects in the coming months.
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