Page 41 - Breakthrough Device News Today

Share this article MONTREAL, Feb. 8, 2021 /PRNewswire/ - Puzzle Medical Devices Inc., ( www.puzzlemed.com) announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its revolutionary transcatheter pump to address heart failure. The FDA Breakthrough Device Program is intended to help patients receive more timely access to certain medical devices that have the potential to provide more effective treatment for life-threatening or...

Press release content from Globe Newswire. The AP news staff was not involved in its creation. Neovasc Comments on Journal of the American Heart Association Publication Neovasc, Inc.February 5, 2021 GMT VANCOUVER and MINNEAPOLIS, Feb. 05, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Neovasc, Inc. (“Neovasc” or the “Company”) ( NASDAQ,  TSX: NVCN) today announced that the Journal of the American Heart Association has published an article entitled,  “Angina Severity, Mortality, and He...

Aethlon Medical to Release Third Quarter Financial Results and Host Conference Call on February 10, 2021 News provided by Share this article Share this article SAN DIEGO, Feb. 4, 2021 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical device technology company focused on unmet needs in global health, today announced that it will issue financial results for its third quarter fiscal year 2021, ended December 31, 2020, at 4:15 p.m. EST on Wednesday, February 10, 2021. Management will ...

Press release content from Globe Newswire. The AP news staff was not involved in its creation. Neovasc Announces 2021 Renewal of German Reimbursement NUB Status 1 Designation for Neovasc ... Neovasc, Inc.February 2, 2021 GMT VANCOUVER and MINNEAPOLIS, MN, Feb. 02, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire  -- Neovasc,  Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced that the German Institute for the Hospital Remuneration System(“InEK”) has awarded the Neova...

(2) Vancouver, British Columbia and Minneapolis, Minnesota--(Newsfile Corp. - February 2, 2021) - Neovasc, Inc. (NASDAQ: NVCN) (TSX: NVCN) ("Neovasc" or the "Company") today announced that the German Institute for the Hospital Remuneration System("InEK") has awarded the Neovasc Reducer ("Reducer"), a CE-Marked medical device for the treatment of refractory angina, NUB Status 1 designation once again for 2021. New examination and treatment methods (NUBs) are comprised of novel and innovative m...

Press release content from Globe Newswire. The AP news staff was not involved in its creation.

Occlutechs Atrial Flow Regulator for Heart Failure Receives FDA Breakthrough Device Designation The Occlutech implantable Atrial Flow Regulator (AFR) maintains an interatrial shunt with a predetermined diameter allowing for controlled blood flow from the left to the right atrium enabling the left atrium to decompress and lower left atrial pressure. This reduced left atrial pressure reduces heart failure symptoms and improves exercise tolerance.   January, 27, 2021 — The U.S. Food and Drug A...

Share this article Share this article MONMOUTH JUNCTION, N.J., Jan. 21, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the world, announces the immediate appointment of David D. Cox, Ph.D., M.B.A., as Vice President – Global Regulatory Affairs. Dr. Cox was most recently Vice President of Regulator...

Share this article Share this article SCHAFFHAUSEN, Switzerland, Jan. 19, 2021 /PRNewswire/ -- Occlutech, a privately-held company, announced today that the U.S Food and Drug Administration (FDA) has granted the Company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients with preserved (HFpEF) or reduced (HFrEF) ejection fraction. Heart failure (HF) is a serious condition characterized by the hearts inability to pump...

Paige, a New York-based computational pathology startup, raised $100 million in a series C funding round. The company develops clinical decision support algorithms for oncology.