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    Alafair Biosciences’s VersaWrap device receives FDA 510(k) clearance

    Image credit: Alafair Biosciences/PRNewswire.Alafair Biosciences has received 510(k) clearance from the US Food and Drug Administration (FDA) for its VersaWrap class II medical device. The approval enables...

    BiVACOR wins IDE to start first-in-human study for artificial heart

    The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to BiVACOR’s total artificial heart (BTAH), greenlighting the way for...

    Paragonix completes first-in-human use of lung preservation system

    Paragonix Technologies has announced the completion of the world’s first-in-human use of the BAROguard Donor Lung Preservation System by Duke University Medical Center in the US. Earlier...

    Xeltis reveals 12-month trial data for aXess haemodialysis access graft

    The Netherlands-based medtech Xeltis has presented trial results for its aXess haemodialysis access graft showing 0% infection rates at 12 months. The data from the...

    Avation Medical confirm safety and efficacy data on smart bladder control system

    Avation Medical has announced positive results from the multi-centre trial of Vivally, its medical device to treat overactive bladder (OAB) syndrome.  The FREEOAB multi-centre study...

    Cardiawave lays next steps for ultrasound therapy after positive FIH trial

    Cardiawave has initiated a pivotal trial investigating its non-invasive ultrasound therapy, after its device demonstrated positive results in the treatment of calcific aortic stenosis...

    VESTECK, Inc. continues procedural success and conducts 2 additional clinical cases to tackle endovascular aortic disease repair

    In response to a significant global unmet need in endovascular aortic disease repair (EVAR/TEVAR), VESTECK, Inc. is pleased to announce continued procedural success conducting...

    Further Group partners with cancer clinical trial matcher Massive Bio

    Further Group will tap into Massive Bio’s AI-powered platform to enhance clinical trial matching for cancer patients. Serious illness insurance solution provider Further Group has...

    Artidis commences ANGEL trial for breast cancer care

    Artidis has announced the commencement of its worldwide multicentre clinical trial, ARTIDIS Nanomechanical Generated Measurements for Early Lesions (ANGEL), for breast cancer care. The trial is led...

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