BRISBANE, Calif., July 23, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to mavacamten, a novel, oral, allosteric modulator of cardiac myosin, for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy (HCM). The FDA’s Breakthrough Therapy […]
Author: Ken Dropiewski
Angel Medical Systems Appoints New CEO
Gordie Nye Succeeds Founder David Fischell as of July 20, 2020. EATONTOWN, N.J., July 23, 2020 /PRNewswire/ — Angel Medical Systems INC is pleased to announce the appointment of Gordie Nye as its new Chief Executive Officer. Gordie succeeds the company’s founder David Fischell, who will become the Chairman of the Board and trusted advisor to […]
Edwards Lifesciences Reports Second Quarter Results
IRVINE, Calif., July 23, 2020 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today reported financial results for the quarter ended June 30, 2020. Second Quarter Highlights and Outlook Sales declined 15% to $925 million; underlying1 sales declined 14% TAVR sales declined […]
Venock Inc. Paves the Way for First Universal Large Bore Vascular Closure System Designed for Veins and Arteries
NEW YORK & MUNICH–(BUSINESS WIRE)–Privately held medical technology company Venock, Inc., headquartered in New York City, with the subsidiary Venock Medical GmbH in Munich, Germany, announced that it has expanded the design of its large bore venous closure system to also be effective at high pressure conditions for closure of […]
InspireMD Gains Registration Clearance of its CGuard™ Embolic Prevention System (EPS) in Brazil
TEL AVIV, Israel, July 23, 2020 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announced it has obtained registration from the Brazilian registration authority, Agéncia Nacional de Vigiláncia Sanitária […]
Caption Health Receives FDA 510(k) Clearance for Innovation in Point-of-Care Ejection Fraction Evaluation
Latest AI ultrasound tool makes it even easier to automatically assess ejection fraction, a key indicator of cardiac function, at the bedside–including on the front lines of the COVID-19 pandemic BRISBANE, Calif., July 23, 2020 /PRNewswire/ — Caption Health, a leader in medical AI technology, has received FDA 510(k) clearance for an […]
Milestone Pharmaceuticals Announces Regulatory Guidance and Updated Clinical Development Plan for Etripamil in PSVT
– Recently completed NODE-301 and ongoing NODE-301B studies can be used as two efficacy studies supporting a future NDA submission (target p-values of <0.05) – – NODE-301B, renamed the RAPID study, will reopen to enrollment and incorporate a repeat dosing regimen; results anticipated in late 2021/early 2022 – – Proceeds […]
Hancock Jaffe Receives Permission to Proceed with First-in-Human CoreoGraft Study
Patient Selection to Begin Immediately for CoreoGraft Study IRVINE, CA / ACCESSWIRE / July 23, 2020 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that Italian Hospital Asuncion in Paraguay has given the Company permission to proceed with the CoreoGraft first-in-human study. […]
Artio Medical Acquires Flow Forward Medical, Expanding Peripheral Vascular Portfolio
FAIRWAY, Kan., July 23, 2020 /PRNewswire/ — Artio Medical, Inc. (Artio) today announced it has acquired Flow Forward Medical, Inc. (Flow Forward), a medical device company developing innovative methods for establishing and maintaining high-quality vascular access sites to improve outcomes for hemodialysis patients. This stock-for-stock merger transaction in which Flow Forward merged with […]
Boston Scientific Receives FDA Approval for Next-Generation WATCHMAN FLX™ Left Atrial Appendage Closure Device
New stroke risk reduction technology designed to advance procedural performance and safety, treat wider range of patients with non-valvular atrial fibrillation MARLBOROUGH, Mass., July 21, 2020 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. Experience […]



