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    Innoblative wins FDA IDE for electrosurgical device for breast cancer treatment

    Regulatory Approvals
    Innoblative Designs announced today that it received FDA investigational device exemption (IDE) for its Sira RFA electrosurgical device. Chicago-based Innoblative Designs’ SIRA device holds FDA breakthrough device designation. It designed SIRA for use in...

    Innoblative wins FDA IDE for electrosurgical device for breast cancer treatment

    Regulatory Approvals
    Innoblative Designs announced today that it received FDA investigational device exemption (IDE) for its Sira RFA electrosurgical device. Chicago-based Innoblative Designs’ SIRA device holds...

    SpineGuard to transfer of US SpineGuard Inc. to Omnia Medical

    Partnerships
    SpineGuard, an innovative company that deploys its DSG® (Dynamic Surgical Guidance) sensing technology to secure and streamline the placement of bone implants, and Omnia...

    Fire1 heart failure system performs well in first-in-human study

    Clinical Trials
    Fire1 announced positive results from the first-in-human study of its novel, implantable heart failure (HF) management system. The FUTURE-HF study evaluated the safety and feasibility...

    Elixir Medical launches the LithiX hertz contact IVL system in Europe

    Innovation
    Elixir Medical received CE mark for its LithiX hertz contact (HC) intravascular lithotripsy (IVL) system. The Milpitas, California–based company kicked off its commercial launch for...

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    Finance

    Funding

    Clinical Trials

    Fire1 heart failure system performs well in first-in-human study

    Fire1 announced positive results from the first-in-human study of its novel, implantable heart failure (HF) management system. The FUTURE-HF study evaluated the safety and feasibility...

    Data backs Cala neurostim for treating essential tremor

    Cala announced new results from multiple clinical studies further expanding the body of evidence for its TAPS therapy. TAPS (transcutaneous afferent patterned stimulation) therapy...

    Anaconda Biomed enrolls first patient in study of funnel catheter for treating stroke

    Anaconda Biomed announced the enrollment and treatment of the first U.S. patient in a clinical trial of its ANA Funnel Catheter. Dr. Shahram Majidi performed...

    Study backs Median Technologies’ AI lung cancer screening software

    Median Technologies, manufacturer of eyonis™, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a...
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    Innovation

    Regulatory Approvals

    Innoblative wins FDA IDE for electrosurgical device for breast cancer treatment

    Innoblative Designs announced today that it received FDA investigational device exemption (IDE) for its Sira RFA electrosurgical device. Chicago-based Innoblative Designs’ SIRA device holds...

    SpineGuard to transfer of US SpineGuard Inc. to Omnia Medical

    SpineGuard, an innovative company that deploys its DSG® (Dynamic Surgical Guidance) sensing technology to secure and streamline the placement of bone implants, and Omnia...

    Fire1 heart failure system performs well in first-in-human study

    Fire1 announced positive results from the first-in-human study of its novel, implantable heart failure (HF) management system. The FUTURE-HF study evaluated the safety and feasibility...

    Elixir Medical launches the LithiX hertz contact IVL system in Europe

    Elixir Medical received CE mark for its LithiX hertz contact (HC) intravascular lithotripsy (IVL) system. The Milpitas, California–based company kicked off its commercial launch for...

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