The Latest Cardiac and Vascular News
Following Receipt of FDA Breakthrough Device Designation, Market Leading Global Organizations Strengthen their Cooperation to Navigate U.S. Regulatory Pathway BETHLEHEM, Pa., March 31, 2021 /PRNewswire/ — B. Braun Interventional Systems Inc. (BIS) announced today that they will collaborate with Infraredx, a Nipro Company, to accelerate the U.S. Food and Drug Administration (FDA) Investigational Device Exemption […]
Invention opens doors for medical device manufacturers to develop at-home or wearable devices to measure endothelial health BERKELEY, Calif.–(BUSINESS WIRE)–Endothelial function, like blood pressure, is a powerful predictor of heart attack and stroke; emerging studies have linked the COVID-19 virus to endothelial dysfunction. Lawrence Berkeley National Laboratory (Berkeley Lab) has […]
Reduction in chest tube clogging and take back for bleeding shown in randomized prospective clinical trial with PleuraFlow ACT System IRVINE, Calif.–(BUSINESS WIRE)–ClearFlow, Inc., a medical device company based in Irvine, California, has announced positive clinical trial results published in the peer-reviewed Journal of Cardiothoracic Surgery. The findings are reported by cardiac […]
ENGLEWOOD, Colo., March 30, 2021 /PRNewswire/ — Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabilitation, cardiac monitoring and neurological diagnostics today announced the Denver Business Journal has recognized Zynex as the sixth largest Biotechnology/Bioscience public company in Colorado based on number of […]
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) […]
