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    CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation

    Regulatory Approvals
    CorTec GmbH, a pioneer in fully implantable brain-computer interfaces (BCI), announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Brain Interchange system. The designation covers the...

    CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation

    Regulatory Approvals
    CorTec GmbH, a pioneer in fully implantable brain-computer interfaces (BCI), announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation...

    E2 raises $80M Series C for Hēlo thrombectomy system

    Funding
    Endovascular Engineering (E2) announced that it raised $80 million in an oversubscribed Series C financing round. Gilde Healthcare and Norwest co-led the latest financing for...

    Route 92 Medical brings in $50M growth financing

    Funding
    Route 92 Medical announced that it secured $50 million in growth financing to support its neurovascular intervention offerings. New investor Sectoral Asset Management joined lead...

    Vernacare acquires Eakin Surgical Limited

    Mergers & Acquisitions
    H.I.G. Capital-backed Vernacare, a global developer and manufacturer of single-use medical devices and healthcare consumables, today announces that it has completed the acquisition of...

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    Finance

    Funding

    Clinical Trials

    Data supports Boston Scientific Watchman FLX in stroke reduction

    Boston Scientific announced new findings from the CHAMPION-AF trial supporting its Watchman FLX system. Watchman FLX, Boston Scientific’s left atrial appendage closure (LAAC) device, reduces...

    iPerf enrolls first patient in study of dual-flow femoral artery cannula

    iPerf announced the first-in-human use of its new dual-flow femoral arterial cannula device. Lyon, France-based iPerf designed its device to integrate an additional flow...

    Providence Medical enrols first patients in CORUS-LX system trial

    Providence Medical Technology has enrolled the first subjects in its prospective, randomised controlled trial (RCT) assessing the CORUS-LX system to treat degenerative lumbosacral disease. The...

    Senseonics reports sustained year-long CGM implant outcomes

    Senseonics announced new data from a real-world study demonstrating the sustained performance of its Eversense 365 CGM. Real-world evidence demonstrated the long-term performance and positive...

    Innovation

    Regulatory Approvals

    CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation

    CorTec GmbH, a pioneer in fully implantable brain-computer interfaces (BCI), announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation...

    E2 raises $80M Series C for Hēlo thrombectomy system

    Endovascular Engineering (E2) announced that it raised $80 million in an oversubscribed Series C financing round. Gilde Healthcare and Norwest co-led the latest financing for...

    Route 92 Medical brings in $50M growth financing

    Route 92 Medical announced that it secured $50 million in growth financing to support its neurovascular intervention offerings. New investor Sectoral Asset Management joined lead...

    Vernacare acquires Eakin Surgical Limited

    H.I.G. Capital-backed Vernacare, a global developer and manufacturer of single-use medical devices and healthcare consumables, today announces that it has completed the acquisition of...

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