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    Regulatory Approvals

    Freyja wins FDA clearance for VereSee device 

    Early-stage medical device company Freyja Healthcare has received 510(k) clearance from the US Food and Drug Administration (FDA) for its VereSee device, used in...

    OrthoXel wins FDA clearance for hip fracture nail

    OrthoXel announced that it received FDA 510(k) clearance for its Vertex hip fracture nail (HFN) for fracture fixation. The Cork, Ireland-based company says its nail...

    4C Medical wins dual FDA breakthrough nods for mitral valve replacement device

    4C Medical Technologies announced the FDA granted breakthrough device designation for its AltaValve system. The company received designations for two therapeutic indications for the...

    FDA issues 510(k) clearance for US Medical Innovations’ ablation system

    The US Food and Drug Administration (FDA) has issued 510k clearance for US Medical Innovations’s Canady Helios Cold Plasma (CHCP) Ablation System, a new...

    RapidAI Secures FDA Clearance for Perfusion Imaging in the Angiography Suite

    RapidAI, the global leader in developing clinically deep Artificial Intelligence (AI) and technology workflow solutions to combat life-threatening neurovascular, cardiac, and vascular diseases, announced...

    ZygoFix wins FDA clearance for zLock lumbar fixation system

    ZygoFix today announced it received FDA 510(k) clearance for its zLock Lumbar Facet Fixation system. The Israel-based company said the milestone was supported by...

    MCRA Supports Darmiyan with FDA Approval for BrainSee Device

    MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in...

    Toku bags breakthrough designation for kidney disease eye scan device

    California-based Toku has seen its artificial intelligence (AI) system for identifying kidney disease awarded the US Food and Drug Administration (FDA) breakthrough device designation. The...

    FDA clears Route 92 Medical’s FreeClimb 54 reperfusion system

    Route 92 Medical announced it received FDA 510(k) clearance for its FreeClimb 54 reperfusion system. The FreeClimb54 system uses an aspiration catheter of the same...
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