FDA Breakthrough Device Designation

In the Know: Healthcare News for September 8, 2020

CMS agrees to cover ‘breakthrough’ medical devices New Technologies Are Ushering in the Biggest Revolution in Senior Care in Over a Century University of Minnesota’s microbiology research facility key to national ‘moonshot’ effort to fight COVID FDA approves Medtronic MiniMed 770G insulin pump for young children Baxter’s dialysis filter wins De Novo nod Like Nothing […]

Envoy Medical Receives FDA Breakthrough Device Designation for its Fully Implanted Acclaim® Cochlear Implant

preCARDIA, Inc. Receives FDA Breakthrough Device Designation for Novel, Catheter Based Heart Failure Treatment

Pioneering technology is designed to address Acute Decompensated Heart Failure ST. PAUL, Minn., June 23, 2020 /PRNewswire/ — preCARDIA, Inc., has announced that the company’s catheter based system for treating volume overload in patients with acutely decompensated heart failure (ADHF) has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA). The […]