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    Quidel Receives Amended Emergency Use Authorization for New Sofia® Q Rapid Antigen Test Device

    Sofia® Q device features a miniaturized, AI-powered design Quidel plans initial release to professional and point-of-care segments with a goal of expansion to serve telemedicine and...

    Medtronic bags FDA approval for Vanta implantable neurostimulator

    Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval for Vanta™, a high performance...

    Neurescue’s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest

    Device is FDA IDE approved to start a clinical study in the U.S. to investigate a novel cardiac arrest treatment indication Neurescue, a medical device...

    Ibex Granted FDA Breakthrough Device Designation

    Ibex Medical Analytics, a specialist in AI-powered cancer diagnostics, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), which...

    Cognoa’s AI app for diagnosing childhood autism gets FDA green light

    In a first for the use of artificial intelligence in healthcare, the FDA has given a green light to a program designed to help...

    AI triage solution for deadly vascular conditions receives FDA clearance and CE Mark

    Avicenna.AI announces the introduction of CINA CHEST, including AI tools for detection and emergency triage of pulmonary embolism and aortic dissection Medical imaging AI specialist Avicenna.AI announced...

    Mental Healthtech Woebot Gets FDA Breakthrough Device Designation

    WB001 is the first digital therapeutic designed to reduce the burden of postpartum depression Woebot Heath, a pioneer in the development of relational technologies and tools to...

    iRhythm gains two FDA approvals for updates to its Zio system

    iRhythm Technologies has announced two US Food and Drug Administration (FDA) 510K clearances—one for a new and improved design of its flagship monitor and...

    Ibex AI-enabled breast cancer diagnostic lands CE mark

    Ibex Medical Analytics announced today that it received CE mark approval for its Galen AI-based breast cancer diagnostic platform. Tel Aviv, Israel–based Ibex’s Galen platform uses...

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