Regulatory Approvals

Vascular Flow Technologies Limited, a designer and developer of implantable medical devices to improve outcomes within the cardiovascular system, has announced that US Patent 11033377...

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...

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...

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...

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

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 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...

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...