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    Vesalio secures FDA clearance for enVast clot retriever

    Regulatory Approvals
    The Food and Drug Administration (FDA) has granted 510(k) clearance for Vesalio’s enVast clot retriever, paving the way for its commercial launch in the US. The device is said to be the first clot retriever...

    Vesalio secures FDA clearance for enVast clot retriever

    Regulatory Approvals
    The Food and Drug Administration (FDA) has granted 510(k) clearance for Vesalio’s enVast clot retriever, paving the way for its commercial launch in the...

    Nephrodite’s continuous dialysis implant wins FDA breakthrough device designation

    Regulatory Approvals
    The FDA has granted Breakthrough Device Designation to Nephrodite’s Holly implantable continuous dialysis system. In an exclusive interview ahead of the official announcement, Nephrodite co-founder...

    GS MedTech Funding Tracker – Saluda, WELLSTAR and more

    GS Funding Tracker
    Strategic capital and acquisitions are driving rapid progress across multiple therapeutic and diagnostic areas. With funding flowing into neuromodulation, AI diagnostics, surgical robotics, and...

    Subsense expands financing to $27M for non-surgical brain-computer interfaces

    Funding
    Subsense, a developer of non-surgical invasive, nanoparticle-based brain-computer interfaces (BCIs), has added $10 million in new capital following positive early breakthroughs, bringing total funding...

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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

    Vesalio secures FDA clearance for enVast clot retriever

    The Food and Drug Administration (FDA) has granted 510(k) clearance for Vesalio’s enVast clot retriever, paving the way for its commercial launch in the...

    Nephrodite’s continuous dialysis implant wins FDA breakthrough device designation

    The FDA has granted Breakthrough Device Designation to Nephrodite’s Holly implantable continuous dialysis system. In an exclusive interview ahead of the official announcement, Nephrodite co-founder...

    GS MedTech Funding Tracker – Saluda, WELLSTAR and more

    Strategic capital and acquisitions are driving rapid progress across multiple therapeutic and diagnostic areas. With funding flowing into neuromodulation, AI diagnostics, surgical robotics, and...

    Subsense expands financing to $27M for non-surgical brain-computer interfaces

    Subsense, a developer of non-surgical invasive, nanoparticle-based brain-computer interfaces (BCIs), has added $10 million in new capital following positive early breakthroughs, bringing total funding...

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