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    FDA clears CMR Surgical’s Versius Plus robot

    Regulatory Approvals
    CMR Surgical has secured US Food and Drug Administration (FDA) clearance for its Versius Plus minimally invasive robotic surgical system, priming the company to go ahead with US commercialisation plans in 2026. Indicated for gallbladder...

    FDA clears CMR Surgical’s Versius Plus robot

    Regulatory Approvals
    CMR Surgical has secured US Food and Drug Administration (FDA) clearance for its Versius Plus minimally invasive robotic surgical system, priming the company to...

    Ultromics secures strategic investment from the American Heart Association

    Funding
    Ultromics, a pioneer in AI-driven cardiology solutions, today announced an investment from the American Heart Association’s Go Red for Women Venture Fund, a fund...

    Medivis wins FDA clearance for AR cranial navigation platform

    Regulatory Approvals
    Medivis announced today that it received FDA 510(k) clearance for its augmented reality (AR)-powered Cranial Navigation platform. The company said clearance makes Cranial Navigation the...

    May Health gains CE mark for infertility treatment

    Regulatory Approvals
    France-based May Health has secured a European CE mark for its Anavi system to address infertility in women with polycystic ovary syndrome (PCOS). The system...

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    Finance

    Funding

    Clinical Trials

    JenaValve reports positive Trilogy heart valve data for aortic regurgitation

    JenaValve announced new results from an expanded patient cohort supporting the use of its Trilogy transcatheter heart valve (THV) system. Results from the ALIGN-AR pivotal...

    Vexev robotic ultrasound study meets endpoints

    Vexev and U.S. Renal Care announced successful results from the CANSCAN trial of the VxWave robotic ultrasound imaging system. Sydney, Australia-based Vexev develops the...

    Hyperion completes first-in-human study of Ivy robotic vascular access platform

    Hyperion Surgical announced today that it completed the world’s first robotic-assisted intravenous (IV) catheterisation using its Ivy platform. Ivy integrates advanced imaging, AI and robotic...

    AtriCure treats first patient in the BoxX-NoAF clinical trial

    AtriCure, a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management and post-operative pain management, today announced...

    Innovation

    Regulatory Approvals

    FDA clears CMR Surgical’s Versius Plus robot

    CMR Surgical has secured US Food and Drug Administration (FDA) clearance for its Versius Plus minimally invasive robotic surgical system, priming the company to...

    Ultromics secures strategic investment from the American Heart Association

    Ultromics, a pioneer in AI-driven cardiology solutions, today announced an investment from the American Heart Association’s Go Red for Women Venture Fund, a fund...

    Medivis wins FDA clearance for AR cranial navigation platform

    Medivis announced today that it received FDA 510(k) clearance for its augmented reality (AR)-powered Cranial Navigation platform. The company said clearance makes Cranial Navigation the...

    May Health gains CE mark for infertility treatment

    France-based May Health has secured a European CE mark for its Anavi system to address infertility in women with polycystic ovary syndrome (PCOS). The system...

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