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Thu, Jun 19, 2025

510(k)

Home » Topics » Regulatory » 510(k)
  • 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.
  • David luria ziv menshes 11apr25
    April 11, 2025
    By Shani Alexander

    Cardiovia Viaone epicardial access system secures US FDA clearance

    Cardiovia Ltd.' Viaone epicardial access system received U.S. FDA clearance for treating cardiac arrhythmias. The device provides clinicians with a safe and minimally invasive technology to reach the heart’s outer surface, known as the pericardial space, without the need for a sharp needle, which can cause perforation.
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