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    Regulatory Approvals

    Meditrina secures UKCA, CE Mark approvals for Aveta Hysteroscopy System

    US-based gynecologic medical devices company Meditrina has received the UKCA Mark and CE Mark approvals for its fully disposable Aveta Hysteroscopy System. Hysteroscopy is a...

    Profound Medical wins FDA clearance for AI to support prostate cancer procedure

    Profound Medical announced today that it received FDA 510(k) clearance for its second AI model for treating prostate cancer. Toronto-based Profound Medical develops and...

    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...
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