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    Butterfly Network wins FDA clearance for GA AI ultrasound tool

    Regulatory Approvals
    Butterfly Network announced that it received FDA clearance for a fully automated gestational age (GA) tool for its handheld ultrasound. Burlington, Massachusetts–based Butterfly develops a single-probe, whole-body ultrasound system with seamless AI integration. Now, it...

    Butterfly Network wins FDA clearance for GA AI ultrasound tool

    Regulatory Approvals
    Butterfly Network announced that it received FDA clearance for a fully automated gestational age (GA) tool for its handheld ultrasound. Burlington, Massachusetts–based Butterfly develops a...

    Serenity Medical earns FDA HDE for cerebral venous stent

    Regulatory Approvals
    Serenity Medical announced that it received FDA Humanitarian Device Exemption (HDE) approval for its novel River stent. Harrison, New York-based Serenity said approval makes River...

    Lucida Medical raises £8.7M to power ‘same day’ cancer diagnosis

    Funding
    IW Capital has invested in Lucida Medical, a UK-based healthtech company using AI to help clinicians diagnose prostate cancer from MRI scans faster and...

    Data supports Boston Scientific Watchman FLX in stroke reduction

    Clinical Trials
    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...

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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

    Butterfly Network wins FDA clearance for GA AI ultrasound tool

    Butterfly Network announced that it received FDA clearance for a fully automated gestational age (GA) tool for its handheld ultrasound. Burlington, Massachusetts–based Butterfly develops a...

    Serenity Medical earns FDA HDE for cerebral venous stent

    Serenity Medical announced that it received FDA Humanitarian Device Exemption (HDE) approval for its novel River stent. Harrison, New York-based Serenity said approval makes River...

    Lucida Medical raises £8.7M to power ‘same day’ cancer diagnosis

    IW Capital has invested in Lucida Medical, a UK-based healthtech company using AI to help clinicians diagnose prostate cancer from MRI scans faster and...

    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...

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