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Wed, Jun 18, 2025

510(k)

Home » Topics » Regulatory » 510(k)
  • 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.
  • Lunit insight mmg 10apr25
    April 10, 2025
    By Marian (YoonJee) Chu

    AI-enhanced mammogram readings are better, but ignored

    AI could significantly improve the value of patient recalls following mammography, but so far radiologists seem reluctant to rely on computer-aided readings. Radiologists tend to trust their own judgment – and that of their colleagues – in mammogram readings far more than AI-based diagnostics, even when the AI is much more accurate, a prospective trial analysis published in Radiology by Karolinska Institutet researchers found.
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