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    Regulatory Approvals

    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...

    Epitomee gets FDA approval for ingestible weight management device

    Israel-based health solutions provider Epitomee Medical has received the US Food and Drug Administration (FDA) approval for its advanced ingestible medical device, Epitomee Capsule. Encased...

    Argon Medical Launches CLEANER Vac Thrombectomy System

    Argon Medical Devices has launched its CLEANER Vac thrombectomy system, which removes blood clots from the peripheral venous vasculature. The disposable, large-bore aspiration system was...

    Penumbra secures CE mark for CAVT technologies in Europe

    Penumbra has received a CE mark for its latest computer-assisted vacuum thrombectomy (CAVT) technologies in Europe. These products, Lightning Flash 2.0 and Lightning Bolt 7,...
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