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Fri, Jul 11, 2025

510(k)

Home » Topics » Regulatory » 510(k)
  • 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.
  • Neuromark system 18jun25
    June 18, 2025
    By Shani Alexander

    Rising demand spurs Neurent to open new Neuromark facility

    Amid rising demand for its Neuromark system, Neurent Medical Ltd. opened a new manufacturing facility in Ireland, which will serve as the central hub for the production of the device which treats chronic rhinitis.
  • 12 8 dexcom g7 cgm
    April 11, 2025
    By Annette Boyle

    FDA clears Dexcom G7 15 Day

    The battle to claim the continuous glucose monitor with the longest wear time continues with Dexcom Inc.’s G7 15 Day continuous glucose monitor gaining U.S. FDA clearance on April 10 for adults with diabetes. The company said it now takes the lead with the 15-day duration, but Abbott Laboratories also offers 15 days of useful life for its Freestyle Libre 3 plus.
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