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    Vdyne wins FDA IDE to study tricuspid valve replacement

    Regulatory Approvals
    Vdyne announced that it received FDA investigational device exemption (IDE) for a pivotal trial evaluating its heart valve system. Maple Grove, Minnesota-based Vdyne develops a transcatheter tricuspid valve replacement (TTVR) system. IDE approval enables the...

    Vdyne wins FDA IDE to study tricuspid valve replacement

    Regulatory Approvals
    Vdyne announced that it received FDA investigational device exemption (IDE) for a pivotal trial evaluating its heart valve system. Maple Grove, Minnesota-based Vdyne develops a...

    Merit Medical acquires View Point Medical for $140M

    Mergers & Acquisitions
    Merit Medical Systems announced that it acquired View Point Medical in a deal worth approximately $140 million. South Jordan, Utah-based Merit agreed to pay $90...

    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...

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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

    Vdyne wins FDA IDE to study tricuspid valve replacement

    Vdyne announced that it received FDA investigational device exemption (IDE) for a pivotal trial evaluating its heart valve system. Maple Grove, Minnesota-based Vdyne develops a...

    Merit Medical acquires View Point Medical for $140M

    Merit Medical Systems announced that it acquired View Point Medical in a deal worth approximately $140 million. South Jordan, Utah-based Merit agreed to pay $90...

    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...

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