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    Anumana secures FDA clearance for ECG-AI algorithm

    Regulatory Approvals
    Anumana, a leader in cardiovascular AI, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its pulmonary hypertension (PH) algorithm, an AI-enabled software-as-a-medical-device (SaMD) that detects early signs of PH, a serious...

    Anumana secures FDA clearance for ECG-AI algorithm

    Regulatory Approvals
    Anumana, a leader in cardiovascular AI, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its pulmonary hypertension (PH) algorithm, an AI-enabled...

    Neurovalens receives EU MDR compliance for sleep insomnia device

    Regulatory Approvals
    Northern Irish company Neurovalens has received the EU Medical Device Regulation (MDR) compliance for its prescribed insomnia device, Modius Sleep. This product is now approved...

    4DMedical receives CE Mark for CT:VQ, enabling EU launch

    Regulatory Approvals
    4DMedical Limited, the global leader in cardiothoracic imaging software, announces that its latest imaging technology, CT:VQ™ has received CE Mark certification for commercial use...

    GS MedTech Funding Tracker – Endogenex, Vaxess, and more

    GS Funding Tracker
    This week’s MedTech funding rounds underscore accelerating innovation across metabolic health, precision oncology, and advanced drug-delivery platforms. Investors are backing companies driving clinical trials,...

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    Finance

    Funding

    Clinical Trials

    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...

    Arsenal Medical announces first patient treated with ResQFoam

    Arsenal Medical, a clinical-stage company pioneering innovative biomaterials-based devices, announced the first patient treated with a first-of-its-kind device, ResQFoam™, in the REVIVE clinical study...

    Innovation

    Regulatory Approvals

    Anumana secures FDA clearance for ECG-AI algorithm

    Anumana, a leader in cardiovascular AI, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its pulmonary hypertension (PH) algorithm, an AI-enabled...

    Neurovalens receives EU MDR compliance for sleep insomnia device

    Northern Irish company Neurovalens has received the EU Medical Device Regulation (MDR) compliance for its prescribed insomnia device, Modius Sleep. This product is now approved...

    4DMedical receives CE Mark for CT:VQ, enabling EU launch

    4DMedical Limited, the global leader in cardiothoracic imaging software, announces that its latest imaging technology, CT:VQ™ has received CE Mark certification for commercial use...

    GS MedTech Funding Tracker – Endogenex, Vaxess, and more

    This week’s MedTech funding rounds underscore accelerating innovation across metabolic health, precision oncology, and advanced drug-delivery platforms. Investors are backing companies driving clinical trials,...

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