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    Regulatory Approvals

    Q’Apel Medical wins CE mark for Armadillo neurovascular access system

    Q’Apel Medical received CE mark certification for its Armadillo SelectFlex Neurovascular Access System. The 7F system uses the company’s SelectFlex Technology and is indicated...

    Biobot Surgical wins CE mark for Mona Lisa surgical robot

    Biobot Surgical received CE mark for its Mona Lisa 2.0 surgical robotic platform for urology applications. Approval in Europe adds to existing approvals in...

    FDA clears CapsoVision capsule endoscopy tech for pediatric patients

    CapsoVision announced today that the FDA cleared its CapsoCam Plus system for use in pediatric patients aged two and above. The CapsoCam Plus system...

    neuroClues secures CE certification for its eye-tracking technology set to enhance neurologic care

    neuroClues, a European MedTech company specialising in the diagnosis of neurodegenerative diseases, received the MDR certificate for its groundbreaking eye-tracking device. Innovation in the EU...

    The FDA clears Magstim Horizon INSPIRE TMS system

    Magstim won U.S. Food and Drug Administration (FDA) clearance for the Horizon Inspire System, which provides physicians, nurse practitioners, clinicians, and researchers with next-generation...

    FDA grants IDE approval for the pivotal trial of Roivios’ JuxtaFlow® renal assist device

    Roivios, a pioneering clinical-stage medical device company dedicated to revolutionising kidney health, announced its research and development arm, 3ive Labs, has secured approval for...

    Onward wins FDA De Novo classification for non-invasive spinal cord stimulation system

    Onward Medical received FDA de novo clearance for its ARC-EX spinal cord stimulation (SCS) system. ARC-EX SCS therapy delivers targeted, programmed electrical stimulation transcutaneously...

    HeartBeam’s arrhythmia assessment system gains FDA 510(k) clearance

    HeartBeam has gained the US Food and Drug Administration’s 510(k) clearance for its comprehensive arrhythmia assessment system. The patented high-fidelity electrocardiogram (ECG) HeartBeam device, distinguished...

    Cercare Medical secures FDA clearance for CT Perfusion Imaging software

    Cercare Medical announced FDA clearance for its CT perfusion imaging software, a significant milestone that complements the existing clearance for MRI perfusion imaging. This...
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