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    Zoll scores FDA approval for updated sleep apnea implant acquired in Respicardia buyout

    Only a few months after Zoll Medical acquired neurostimulation device maker Respicardia, the investment is already paying off. An updated version of Respicardia’s Remede system...

    Volpara Receives FDA Clearance for Breast Density Algorithm

    Software improves on breast density assessment algorithm with artificial intelligence. Volpara Health announced Friday it has received 510(k) clearance from the U.S. Food & Drug...

    Biofourmis Earns FDA’s First-Ever Breakthrough Device Designation for a Novel Digital Therapeutic for Heart Failure

    BiovitalsHF® Approved for Expedited FDA Review Process as a First-in-Class DTx for Heart Failure that Augments Traditional Guideline-Directed Medical Therapy Biofourmis, a Boston-based global leader in...

    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...

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