Tag: FDA

Penumbra’s Newest Generation of Indigo Aspiration System Receives FDA Clearance for Pulmonary Embolism

Lightning 12 and Separator 12 Now Indicated for Treatment of PE ALAMEDA, Calif.–(BUSINESS WIRE)–Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the latest […]

Corvia Medical Completes Randomization In REDUCE LAP-HF II Pivotal Trial And Gains FDA Authorization To Provide Continued Access For The Corvia Atrial Shunt

Large randomized, sham-controlled trial evaluates interatrial shunting in a heart failure population currently without effective treatment TEWKSBURY, Mass., Nov. 17, 2020 /PRNewswire/ — Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure (HF), today announced completion of randomization […]