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BioWorld - Thursday, December 4, 2025

510(k)

Home » Topics » Regulatory » 510(k)
  • 12 8 dexcom g7 cgm
    Nov. 19, 2025
    By Annette Boyle

    FDA clears Dexcom Smart Basal for insulin optimization

    Dexcom Inc. received U.S. FDA clearance for its Smart Basal CGM-integrated basal insulin dosing optimizer. Designed for adults with type 2 diabetes using glargine U-100 long-acting insulin therapy, Smart Basal uses data from Dexcom’s G7 15 Day sensor with doses logged by the user to personalize recommendations and adjust long-acting insulin doses, with direction from the patient’s health care provider.
  • Withings beamo 14nov25
    Nov. 14, 2025
    By Shani Alexander

    FDA clears Withings Beamo, ‘thermometer of the future’

    Withings SA received U.S. FDA clearance for Beamo, its health check-up tool designed to monitor heart and lung function. Described as the ‘thermometer of the future’, Beamo combines the sensors of an electrocardiogram, a stethoscope and a thermometer into a hand-held device to allow users to check their body temperature, cardiac and pulmonary health in less than a minute.
  • Magstim 12nov24
    Nov. 12, 2025
    By Holland Johnson

    Magstim gets FDA nod for chronic pain treatment

    Magstim Co. Ltd. reported that the U.S. FDA cleared its Magstim Rapid magnetic stimulation system for the treatment of chronic pain. The clearance provides a clinically validated therapy that directly targets neural pathways involved in pain processing to deliver a non-invasive, drug-free treatment for chronic pain.
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