Author: Ken Dropiewski

FDA Agrees to Expanded Access Program for the BioVentrix® Revivent TC® System for the Treatment of Ischemic Heart Failure

Treatment IDE Will Provide Opportunity to Treat Additional Patients in the US SAN RAMON, Calif., Jan. 24, 2023 /PRNewswire/ — BioVentrix®, Inc., a privately held medical device company focused on the development of less invasive therapies to directly treat the dilated left ventricle and reverse the left ventricular remodeling process of progressive heart […]

Digital cardiovascular care company tenacio launches OptiCor™ patient management platform in the US

tenacio’s OptiCor™ Clinical Decision Support Tool is an easy-to-use tool for clinicians to optimize treatment for patients with atrial fibrillation OptiCor™ has shown significant reductions in mortality and stroke in a previously published study1 BERLIN and NEW YORK, Jan. 24, 2023 /PRNewswire/ — tenacio, whose mission is to improve clinical outcomes for cardiovascular patients and to […]

Understand your body better with the new ECG App from Garmin

FDA-cleared and clinically-validated app lets Venu 2 Plus customers record an ECG and check for signs of atrial fibrillation right from their smartwatch OLATHE, Kan., Jan. 24, 2023 /PRNewswire/ — Garmin (NYSE: GRMN) today announced the ECG App1, an FDA-cleared app for the Venu® 2 Plus smartwatch that allows users to record their heart rhythm and check […]

Humacyte Publication in the Journal of Vascular Surgery – Vascular Science Reports the Human Acellular Vessel™ (HAV™) Remains Durable at Six Years in Patients with Peripheral Artery Disease

– HAVs observed to provide long-term perfusion to patients with critical limb ischemia – 3D Angiograms show mechanical durability of engineered human blood vessels DURHAM, N.C., Jan. 24, 2023 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue […]

HeartBeam Appoints Robert Eno as President

Senior Medical Technology Executive to Enhance Company’s Strategic and Operations Capabilities SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector electrocardiogram (VECG) platform for heart attack detection anytime, anywhere, announced today the appointment of Robert Eno to the newly created position […]

CytoSorbents Announces Health Canada Regulatory Approval For Pivotal STAR-T Trial

PRINCETON, N.J., Jan. 23, 2023 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has received regulatory approval from Health Canada allowing inclusion of Canadian sites into the pivotal Safe and Timely Antithrombotic Removal […]

Cadrenal Therapeutics (Nasdaq: CVKD) Granted FDA Fast Track Designation for Tecarfarin for Prevention of Systemic Thromboembolism of Cardiac Origin in Patients with End-Stage Renal Disease and Atrial Fibrillation

PONTE VEDRA, Fla., Jan. 23, 2023 /PRNewswire/ — Cadrenal Therapeutics (Nasdaq: CVKD), a biopharmaceutical company focused on developing tecarfarin, a clinical-stage novel cardiorenal therapy with orphan drug designation, announced today that the U.S. Food and Drug Administration (FDA) has granted a Fast Track designation to tecarfarin for the prevention of systemic thromboembolism, more commonly referred […]

Aerovate Therapeutics Appoints Donald Santel To Its Board of Directors

WALTHAM, Mass., Jan. 23, 2023 (GLOBE NEWSWIRE) — Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical-stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today announced the appointment of Donald Santel as a member of Aerovate’s Board of Directors. With over 40 […]