The Latest Cardiac and Vascular News
PORTLAND, Ore., Feb. 23, 2021 /PRNewswire/ — Inovise Medical today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its AUDICOR® heart failure management system. The system uses clinically tested algorithms to detect the risk of decompensation at home in patients who have been previously hospitalized for heart failure. […]
LEUVEN, Belgium and BOSTON, Feb. 23, 2021 /PRNewswire/ — icometrix, world leader in imaging AI solutions for people with neurological conditions, announced the addition of icobrain cva, a stroke solution, to the icobrain portfolio. The announcement follows the FDA-clearance and CE-marking of its image processing software for the analysis and communication of the tissue perfusion state […]
20-vial pack provides a green packaging alternative and helps increase storage efficiency MONROE TOWNSHIP, N.J., Feb. 22, 2021 /PRNewswire/ — Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world’s leading companies in the diagnostic imaging business, announced today that its ultrasound enhancing agent (UEA) LUMASON® (sulfur hexafluoride lipid-type […]
Transformative Technology Now Available for Calcified Coronary Plaque SANTA CLARA, Calif., Feb. 16, 2021 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the company’s sonic pressure wave therapy received Pre-Market Approval for […]
Entresto is the first and only therapy approved in the US to treat patients diagnosed with guideline-defined heart failure to include both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF)1-3 Expanded indication enables potential treatment of more adults with […]
FREMONT, Calif. and OXFORD, United Kingdom, Feb. 11, 2021 /PRNewswire/ — Cerus Endovascular Ltd., a privately-held, commercial-stage medical device company, today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Contour Neurovascular System™. Breakthrough Device Designation is granted to medical devices and device-led combination products […]
TARRYTOWN, N.Y., Feb. 11, 2021 /PRNewswire/ — Homozygous familial hypercholesterolemia (HoFH) is an ultra-rare inherited condition that affects approximately 1,300 patients in the U.S. and is characterized by extremely high low-density lipoprotein cholesterol (LDL-C) In pivotal Phase 3 HoFH trial, adding Evkeeza to standard lipid-lowering therapies reduced LDL-C by nearly half at 24 […]
First enrollment in the study expected in Q1 2021 PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today provides […]
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 […]
Expands portfolio across Health, Wellness and User Identification for deployment in consumer and medical technology sectors BELFAST, Northern Ireland–(BUSINESS WIRE)–B-Secur, a leader in EKG/ECG technology, today announced that it has received U.S. Food and Drug Administration (FDA) 510(K) clearance of its HeartKey® software library1. B-Secur’s HeartKey® is a suite of powerful […]
