The Latest Cardiac and Vascular News
Announces Preliminary Revenue Range for the First Quarter of 2021 SANTA CLARA, Calif., March 30, 2021 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today announced a preliminary forecast revenue range for the first quarter […]
QUEBEC CITY–(BUSINESS WIRE)–Devonian Health Group Inc. (“Devonian” or the “Corporation”) (TSXv: GSD), a clinical stage botanical pharmaceutical corporation, focused on developing a unique portfolio of botanical pharmaceutical and cosmeceutical products, announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. patent […]
Submitted for FDA Priority Review as a Rare Pediatric Disease Product Application SEOUL, South Korea, March 28, 2021 /PRNewswire/ — Mezzion Pharma Co. Ltd. (140410.KQ), announced today that it has re-submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of udenafil to improve the exercise capacity of patients […]
New implant device provides less invasive option to treat pulmonary valve regurgitation for patients with a native or surgically-repaired right ventricular outflow tract SILVER SPRING, Md., March 26, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult […]
TAMPA, Fla., March 25, 2021 /PRNewswire/ — Keystone Heart, Ltd., a medical device innovator driven to redefine the standard of structural heart care, today announced an exclusive distribution agreement with InterValve Medical Inc. to sell and market their portfolio of balloon aortic valvuloplasty products, in the United States. InterValve Medical, a Venus Medtech […]
Milestone achieved as company prepares for next stage of commercial growth and expansion LISLE, Ill., March 23, 2021 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced the 100th global implant of the Cordella Pulmonary Artery Pressure Sensor (Cordella Sensor) […]
Collaboration to focus on the continued development of chronic heart failure treatment SERCA2a activator compounds adding to Windtree’s acute treatment Istaroxime WARRINGTON, Pa., March 22, 2021 /PRNewswire/ — Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology and medical device company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today […]
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. 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, […]
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 […]
