SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of convenient, clinical-grade blood collection solutions, today announced that the U.S. Food and Drug Administration (FDA) has cleared its ...

The US Food and Drug Administration (FDA) has tagged Medtronic’s recall of certain Pipeline Vantage embolisation devices as Class I following reports of four patient deaths. A Class I recall is the ...

The FDA has approved a new class of ablation device — Abbott’s Volt pulsed field ablation system — for the treatment of atrial fibrillation. The Volt system delivers high-energy electrical pulses to ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

The US Food and Drug Administration (FDA) has chosen to axe its ‘Final Rule’ from May 2024, bringing to an end a long-running agency-industry dispute around the proposed classification of ...

Orchestra BioMed holds two best-in-class medical device therapies targeting large markets, with strong partnerships and equity investments from Medtronic and Terumo. Both AVIM Therapy and Virtue SAB ...

A recent preemption decision out of the Southern District of New York offers encouraging news for medical device manufacturers. In Wieder v. Advanced Bionics LLC, 2025 WL 3237257 (S.D.N.Y. Nov. 20, ...

The Government Accountability Office (GAO) is urging the U.S. Food and Drug Administration (FDA) to use the most stringent pre-market review process in approving high-risk medical devices, according ...

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...

San Francisco, CA October 13, 2025 –(PR.com)– Cellionyx, a pioneering electroceuticals company, today officially emerged from stealth mode to announce the commercial launch of its flagship product, ...