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    ARVIS Augmented Reality Gains FDA 510(k) Clearance

    Insight Medical Systems gained 510(k) clearance from the FDA for its flagship product, ARVIS® (Augmented Reality Visualization and Information System). This is the first...

    Asensus Surgical Receives FDA 510(k) Clearance for Articulating Instruments

    Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and patient to pioneer a new...

    LifeSignals remote patient monitor wins FDA clearance

    The system is designated to be used by clinicians to monitor patients at home or in the healthcare setting. Wireless healthcare technology developer LifeSignals today...

    Innovative Health Sciences wins CE mark for syringe infusion system

    Innovative Health Sciences announced that it received CE mark approval in Europe for its Insignis syringe infusion system. Chester, N.Y.–based Innovative Health Sciences designed the Insignis...

    FDA approves Nevro’s Senza system to treat chronic pain with diabetic neuropathy

    Nevro (NYSE:NVRO) announced today that it received FDA approval for its Senza system for treating chronic pain associated with PDN. The Redwood City, Calif.-based company’s stock...

    Endologix LLC Receives FDA Breakthrough Device Designation for ChEVAS™ System

    Investigational EVAS System Designed for Patients with Complex Abdominal Aortic Aneurysm Endologix LLC, a leader in the treatment of vascular disease, today announced the company’s...

    AliveCor gains US FDA clearance for KardiaMobile 6L to calculate patients’ QTc interval

    AliveCor has today announced the receipt of 510(k) clearance from the US Food and Drug Administration (FDA) for healthcare professionals to use the KardiaMobile...

    Quidel Receives CE Mark for Savanna® Multiplex Molecular Analyzer and Respiratory Viral Panel

    New Savanna® platform can analyze up to 12 pathogens, plus controls, from a single sample Savanna® RVP4 Assay targets influenza A+B, RSV and COVID-19 Quidel Corporation...

    Natural Cycles receives FDA clearance for birth control wearable

    Natural Cycles, the first FDA cleared birth control app, has received new FDA clearance to revise its labelling and expand the types of third-party...

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