Other News

Evidation Health, American College of Cardiology Announce Achievement for Heart Health, A Program to Help Individuals Monitor and Improve Cardiovascular Health

First-of-its-kind health engagement experience will deliver evidence-based content, resources, and tools to thousands of individuals experiencing heart failure SAN MATEO, Calif.–(BUSINESS WIRE)–Evidation Health and the American College of Cardiology (ACC) announced today they are joining forces to co-develop and launch Achievement for Heart Health–a health engagement experience built on Evidation’s Achievement platform–that will make […]

Analytics 4 Life® Rebrands as CorVista® Health; Appoints Scott Burger as Chief Commercial Officer and Vice President

Company Advancing Proprietary Machine Learning to Improve Care in Cardiology TORONTO–(BUSINESS WIRE)–Analytics 4 Life today announced the appointment of Scott Burger to Chief Commercial Officer and Vice President. Scott will lead the commercialization efforts of the CorVista® System, a non-invasive point-of-care solution that allows physicians to rapidly assess heart function. […]

First-in-class cholesterol-lowering treatment NILEMDO® * (bempedoic acid) tablet and its combination with ezetimibe NUSTENDI® * (bempedoic acid and ezetimibe) tablet approved in Switzerland

– NILEMDO® (bempedoic acid) is the first oral, once-daily treatment approved in almost two decades to lower low-density lipoprotein cholesterol (LDL-C) for indicated patients – – Bempedoic acid and its fixed combination drug product with ezetimibe both deliver significant reductions in LDL-C when added to a statin or other lipid-lowering therapies1,2 – […]

BioCardia, Inc. Announces $10.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

SAN CARLOS, Calif., Dec. 16, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. (Nasdaq: BCDA) (BioCardia or the “Company”) today announced it has entered into definitive agreements with investors for the purchase and sale of 2,038,836 shares of its common stock at a purchase price of $5.15 per share in a registered direct […]

Centerline Biomedical Kicks Off First Clinical Study of Intra-Operative Positioning System Technology

First surgical case launches multicenter prospective clinical study of FDA-cleared product to support international market entry CLEVELAND, Dec. 15, 2020 /PRNewswire/ — Centerline Biomedical, Inc. (Centerline) announced Tuesday the completion of the first surgical case in its MOTION clinical study of its innovative Intra-Operative Positioning System (IOPS™) surgical navigation platform. The FDA-cleared […]

Corvion Receives Breakthrough Device Designation from FDA

WEBSTER, Texas, Dec. 16, 2020 /PRNewswire/ — Corvion – developer of fully implanted mechanical circulatory support devices – announced today that it has received Breakthrough Device Designation for its fully implanted Left Ventricular Assist Device (LVAD) from the FDA.  The designation will allow the company to interact with the FDA’s experts to […]

Okami Medical Announces FDA 510(k) Clearance of the LOBO-5 Vascular Occluder

ALISO VIEJO, Calif., Dec. 16, 2020 /PRNewswire/ — Okami Medical Inc., a medical device company, today announced the expansion of its LOBO™ Vascular Occlusion System product line with the U.S. FDA 510(k) clearance of the LOBO-5 Vascular Occluder. The LOBO (LOw-profile Braided Occluder) system is uniquely designed to provide interventional physicians with a single-device, […]

Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF

The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF) Potential Q1 2021 sNDA approval could make Entresto the first therapy indicated for use in treatment of patients with both major types of […]

Covanos Announces Appointment of Iconic Industry Leader Gil Amelio, Ph.D. to Board of Directors

ATLANTA, Dec. 16, 2020 /PRNewswire/ — Covanos, Inc., a privately-held medical technology company that is developing C-HEART, a PC-based software product that uses proprietary advances in computational fluid dynamics to rapidly and non-invasively diagnose the severity of coronary artery blockages, today announced the appointment of Gil Amelio, Ph.D. to the Covanos Board of Directors. “We are […]

Advanced Bifurcation Systems Announces First Closing Of Series A Financing

LIVERMORE, Calif., Dec. 16, 2020 /PRNewswire/ — Advanced Bifurcation Systems, Inc. (ABS), a Livermore, CA-based maker of the ABS System, a proprietary stent delivery system that is specifically designed to efficiently treat coronary bifurcation lesions, is pleased to announce the first closing of an $11 million Series A equity financing.  The round was led by […]