Other News

VALBIOTIS Obtains ISO 9001 Certification for Its Activities in “Design, Development and Production Control of Solutions for Preventing and Combating Metabolic and Cardiovascular Diseases”

LA ROCHELLE, France–(BUSINESS WIRE)–Regulatory News: VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / eligible for the PEA/SME), a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces that it has obtained ISO 9001 certification for its Quality Management System (QMS) deployed on its three sites. […]

U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

U.S. FDA has assigned a target action date of January 28, 2022 Application based on results from the Phase 3 EXPLORER-HCM trial PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for mavacamten, an investigational, novel, […]

SANUWAVE Health Announces Distribution Agreement with Labb Solutions

SANUWAVE to Distribute dermaPACE® System and UltraMIST® System in Turkey and in Select Eastern Europe and Middle East Countries SUWANEE, GA, March 19, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — SANUWAVE Health, Inc. (OTCQB: SNWV), focused on the development and commercialization of a robust and innovative advanced wound care product portfolio for the repair […]

JenaValve Technology Welcomes Jane Metcalf as Vice President, Regulatory Affairs and Quality

IRVINE, Calif., March 18, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of differentiated pericardial transcatheter aortic valve replacement (TAVR) systems for the treatment of aortic valve disease, announces the appointment of Jane Metcalf to Vice President, Regulatory Affairs and Quality, effective immediately. Ms. Metcalf comes to JenaValve […]

Cytokinetics Announces Secondary Analysis From GALACTIC-HF to Be Presented in Late Breaking Clinical Trial Session at American College of Cardiology 70th Annual Scientific Session & Expo (ACC.21)

SOUTH SAN FRANCISCO, Calif., March 18, 2021 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that data from a secondary analysis of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) assessing the effect of omecamtiv mecarbil on clinical outcomes in relationship to patient baseline ejection fraction will be presented in a Late Breaking Clinical Trial […]

Acutus Medical Reports Fourth Quarter and Full Year 2020 Financial Results

CARLSBAD, Calif., March 18, 2021 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today reported results for the fourth quarter and full year ended December 31, 2020. Recent Highlights: Reported revenue of $2.6 million […]

PaceMate™ Is Now Listed as a Healthcare Solution in Epic’s App Orchard

BRADENTON, Fla.–(BUSINESS WIRE)–PaceMate™, the leading digital healthcare company in compliant cardiac data management, announced today its recent listing with premier electronic health record company Epic. As part of the App Orchard developer program, PaceMate™’s bidirectional, EHR-integrated application is now available to Epic’s vast network of healthcare customers as a comprehensive, […]