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    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...

    Boston Scientific Completes CE Mark for EXALT Model B Single-Use Bronchoscope

    Boston Scientific Corporation (NYSE: BSX) announced it has completed CE Mark for the EXALT™ Model B Single-Use Bronchoscope, a single-use device designed for bedside...

    JenaValve Technology Receives CE Mark for its Trilogy™ TAVI System for the Treatment of Aortic Regurgitation and Aortic Stenosis

    JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve implantation (TAVI) systems (also referred to as TAVR, or transcatheter aortic valve replacement)...

    EndoFresh Obtains FDA 510(k) Clearance for Its Groundbreaking Disposable Digestive Endoscopy System

    The FDA has greenlighted EndoFresh Disposable Digestive Endoscopy System, following years of reports of persistent cross-contamination issues being transmitted among multi-patients by the notoriously...

    amg International GmbH, a Q3 Medical Devices Ltd Company, Receives European CE Mark Approval for UNITY-B™ Biodegradable Stent

    amg International GmbH ("amg" or the "Company"), a wholly owned subsidiary of Dublin, Ireland based Q3 Medical Devices Limited (Q3), further establishes its leadership role in...

    U.S. FDA Approves Aptar’s Proprietary Activ-Film™ Technology for use with Rechargeable Implantable Neurostimulator

    Sophisticated implantable medical device for urinary and bowel dysfunction leverages Aptar’s groundbreaking 3-Phase Activ-Polymer™ technology to control moisture and extend use life. Aptar CSP Technologies,...

    CorVent Medical Secures CE Mark Approval For Its Critical Care RESPOND-19™ Ventilator

     CorVent Medical, a private medtech company focused on developing versatile, lifesaving ventilators for critical care, announced that it has received CE Mark approval and...

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