TORONTO, Dec. 15, 2020 /CNW/ – Baylis Medical announced today the Canadian launch of its EPstar Electrophysiology Catheters. The launch enables physicians to reach previously inaccessible areas of the heart for procedure mapping, by making available the smallest diagnostic catheter in the Canadian electrophysiology market. The EPstar catheter family includes a 2F catheter and a […]
Other News
Foldax Receives FDA Approval to Initiate Clinical Study of Biopolymer Mitral Heart Valve
SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted IDE approval for the company to initiate a U.S. clinical study of its Tria™ biopolymer mitral surgical heart valve. The company anticipates the first use of its mitral valve in a human will […]
BioCardia Anticipates DSMB Feedback on Interim Data From Pivotal Phase 3 CardiAMP Heart Failure Trial
SAN CARLOS, Calif., Dec. 14, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. (Nasdaq: BCDA)(BioCardia or the “Company”) today announces that it anticipates data safety monitoring board (DSMB) verbal feedback by the end of December 15, 2020 on interim data from the Company’s pivotal Phase 3 CardiAMP Heart Failure Trial that is currently enrolling […]
New JAMA Network Open Publication Demonstrates the Coronary CT- HeartFlow Analysis Pathway Is ‘Dominant’ Compared to Stress Testing in Cost-Effectiveness Analysis
REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc., a leader in revolutionizing precision heartcare, announced that a new cost-effectiveness analysis found a diagnostic pathway which utilizes coronary computed tomography angiography (CTA) with the HeartFlow FFRct Analysis to be “dominant” (less costly and more effective) as compared to stress testing for assessing patients with […]
Acceleron Receives Orphan Designation from the European Commission (EC) for Sotatercept in Pulmonary Arterial Hypertension (PAH)
– Sotatercept received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) in PAH in 2019 – – In the spring of 2020, sotatercept received Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), both in PAH – December 14, […]
Caladrius Biosciences Provides Year-End 2020 Strategic Portfolio Update
Program strategy and prioritization supports projection of available capital through 2021 BASKING RIDGE, N.J., Dec. 14, 2020 (GLOBE NEWSWIRE) — Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, today announced that the Company has […]
Amarin Highlights Multiple VASCEPA® (Icosapent Ethyl)-Related Scientific Findings Presented at National Lipid Association (NLA) Scientific Sessions 2020, Including First COVID-19 Clinical Results
REDUCE-IT® EPA Encore Presentation reinforces Eicosapentaenoic Acid (EPA) levels from VASCEPA® (icosapent ethyl) strongly correlated to cardiovascular outcomes, more so than other biomarkers VASCEPA COVID-19 CardioLink-9 Randomized Trial suggests improvement in outpatient-reported COVID-19 symptoms while achieving its primary endpoint by demonstrating a 25% reduction in high-sensitivity C-reactive protein (hsCRP) with […]
Efemoral Medical Announces Successful First-In-Human Use of The Efemoral™ Vascular Scaffold System
New bioresorbable treatment option aims to improve outcomes for patients suffering from peripheral arterial disease LOS ALTOS, Calif., Dec. 14, 2020 /PRNewswire/ — Efemoral Medical, developer of advanced interventional bioresorbable therapies, today announced the first-in-human (FIH) use of the company’s Efemoral™ Vascular Scaffold System (EVSS) with FlexStep™ Technology in the EFEMORAL I FIH clinical study. […]
How Remote Patient Monitoring is Improving Cardiovascular Disease Patient Outcomes, Reports IDTechEx
BOSTON, Dec. 14, 2020 /PRNewswire/ — Cardiovascular disease (CVD) is the leading cause of death worldwide, with over 17 million per year, according to the World Health Organisation. This represents approximately 31% of global deaths. In addition, CVD represents a great strain on healthcare systems worldwide. Total costs to the economy reach […]
BioSig Achieves First Commercial Sale of Three PURE EP Systems
Sale Marks Milestone for Company’s Commercial expansion at leading Center of Excellence Westport, CT, Dec. 11, 2020 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of […]



