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    FDA clears Surmodics’ Pounce XL thrombectomy system

    Surmodics received FDA 510(k) clearance for its Pounce XL thrombectomy system. The FDA indicated Pounce XL for the non-surgical removal of thrombi and emboli...

    Pi-Cardia wins FDA nod for leaflet modification device that enables TAVR

    Pi-Cardia announced the FDA granted clearance for its ShortCut leaflet modification device for TAVR procedures. Rehovot, Israel-based Pi-Cardia designed ShortCut to split the leaflets...

    Human in Motion Robotics secures Canadian approval for XoMotion exoskeleton

    Robotic mobility and humanoid technology company Human in Motion Robotics has received regulatory approval to market and sell the XoMotion exoskeleton in Canada. It is...

    Nevro wins FDA nod for AI-driven spinal cord stimulation tech

    Nevro received FDA approval for an AI-powered, personalised pain management platform for spinal cord stimulation. HFX AdaptivAI, a responsive, personalised pain management platform, powers...

    FDA approves study of Alpha Tau’s Alpha DaRT for recurrent cSCC treatment

    The US Food and Drug Administration (FDA) has granted approval for Alpha Tau Medical’s investigational device exemption (IDE) application to initiate a study of...

    Avicenna.AI receives 510(k) clearance for CINA-CSpine tool

    The US Food and Drug Administration (FDA) has granted 510(k) clearance for Avicenna.AI’s CINA-CSpine tool. This AI solution is developed to automatically detect and prioritise...

    Alesi Surgical wins new funding and FDA clearance for smoke management device

    Alesi Surgical has received FDA 510(k) clearance of its Ultravision2 IonPencil for cutting and coagulating soft tissue in open surgery while managing surgical smoke....

    FDA clears EEG for brain analysis from Forest Devices

    Forest Devices received FDA 510(k) clearance for its SignalNED Model RE system for brain state analysis. This marks the first FDA clearance for the...

    Spinal surgery company Neo Medical wins $68m to expand US business

    Swiss spine technology company Neo Medical has raised $68m in a Series B funding round to expand its portfolio of surgical technologies across the...

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