The Latest Cardiac and Vascular News
Designed solely for antegrade approach, NovaCross™ is positioned to tap into the $500M CTO market, a market with only few players PARDES HANA, Israel, April 7, 2020 /PRNewswire/ — Nitiloop Ltd. to announce that it has received a 510(k) clearance from the U.S. Food & Drug Administration for its NovaCross™ CTO Microcatheter. The NovaCross™ CTO Microcatheter […]
SOUTH JORDAN, Utah, April 06, 2020 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today that it has been granted two additional Breakthrough Device designations […]
First and Only Treatment to Reduce Heart Muscle Damage Following Angioplasty and Stenting CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL® Medical Corporation, an Asahi Kasei Group company that manufactures medical devices and related software solutions, announced today it has received U.S. Food and Drug Administration (FDA) approval of the second-generation TherOx System, which provides SuperSaturated […]
New Technology on the Vantage Galan 3T Can Help Clinicians Reduce Scan Times TUSTIN, Calif.–(BUSINESS WIRE)–Physicians can now scan faster with the newly FDA-cleared Compressed SPEEDER technology from Canon Medical Systems USA, Inc. Available on the Vantage Galan 3T MR system, Compressed SPEEDER technology speeds up MRI scan times by reconstructing full resolution images […]
IRVINE, Calif.–(BUSINESS WIRE)–Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that it has received approval from the United States Food and Drug Administration (FDA) for the Alto™ Abdominal Stent Graft System (Alto). The Company received approval based on its […]
TUCSON, AZ, March 09, 2020 (GLOBE NEWSWIRE) — With the FDA approval of the SynCardia Systems, LLC 50cc TAH-t system a greater number of cardiac transplant eligible patients at risk of imminent death from biventricular failure now have access to total artificial heart therapy. The 50cc TAH-t is 37.5% smaller […]
– Sotalol IV is now approved for 1-day hospital outpatient initiation of AFib therapy and faster dose escalations for existing patients – New FDA-approved dosing, monitoring and evaluation shortens the hospital stay from 3 days to 1 day – The new initiation provides physicians with a faster and safe way […]
SAN DIEGO, March 10, 2020 /PRNewswire/ — Today, AnaBios announced a Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA) to study adult human primary cardiomyocytes as a reference for cellular properties and drug-induced effects on cardiac function. Under the RCA, the FDA Center for Drug Evaluation and Research (CDER) […]
– NEXLIZET Lowered LDL-C by 38 Percent Compared to Placebo when Added on to Maximally Tolerated Statins – – First Non-Statin, LDL-Cholesterol Lowering Combination Medicine Ever Approved – – Esperion’s Second Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in the U.S. Following NEXLETOL™ (bempedoic acid) Tablet Approval on February 21, […]
ENGLEWOOD, Colo., Feb. 25, 2020 /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 U.S. Food and Drug Administration (“FDA”) granted 510(k) clearance for sale in the U.S. for […]
