The Latest Cardiac and Vascular News
MOUNTAIN VIEW, Calif., May 13, 2019 /PRNewswire/ — AliveCor, the leader in FDA-cleared consumer electrocardiogram technology (ECG), today announced its third FDA clearance in three months, making KardiaMobile 6L the world’s first available six-lead personal ECG device. This highly anticipated clearance gives patients and their physicians an even more detailed view into patients’ […]
SAN CARLOS, Calif., May 08, 2019 (GLOBE NEWSWIRE) — BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the AVANCE™ steerable introducer product family, designed for introducing various cardiovascular catheters into the heart, including […]
MARLBOROUGH, Mass., May 6, 2019 /PRNewswire/ — Boston Scientific (NYSE: BSX) announced today that the U.S Food and Drug Administration (FDA) has approved the VICI VENOUS STENT™ System for the treatment of iliofemoral venous obstructive disease, which occurs when the flow of blood through the veins located deep in the pelvic region becomes blocked […]
DUBLIN – May 2, 2019 – Medtronic plc (NYSE:MDT) today announced that the company has received U.S. Food and Drug Administration (FDA) approval for the CareLink SmartSync(TM) Device Manager. With the introduction of SmartSync, physicians will now be able to use an Apple® iPad® to program and manage data from Medtronic’s BlueSync-enabled […]
BOSTON, April 30, 2019 /PRNewswire/ — Biofourmis announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its RhythmAnalyticsTM platform, a cloud-based software for automated interpretation of cardiac arrhythmias. It uses an enhanced deep-learning technique to detect over 15 types of cardiac arrhythmias along with beat-by-beat morphology computation which […]
DUBLIN – May 1, 2019 – Medtronic plc (NYSE:MDT) announced it has received U.S. Food and Drug Administration (FDA) approval for the Attain Stability(TM) Quad MRI SureScan(TM) left heart lead. Paired with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the Attain Stability Quad lead is the only active-fixation left […]
MARLBOROUGH, Mass., April 23, 2019 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the LOTUS Edge™ Aortic Valve System. Delivered via a minimally-invasive procedure, this transcatheter aortic valve replacement (TAVR) technology is approved for patients with severe aortic stenosis who are considered at […]
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sublime™ guide sheath. The highly flexible, proprietary Xtreme® braid-reinforced Sublime sheath is designed to resist kinking […]
REDWOOD CITY, Calif., April 10, 2019 (GLOBE NEWSWIRE) — Avinger, Inc. (Nasdaq: AVGR), a leading developer of image-guided, catheter-based systems for the diagnosis and treatment of patients with Peripheral Artery Disease (PAD), today announced that the Company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its […]
IRVINE, Calif.–(BUSINESS WIRE)–TherOx, Inc., a privately held medical device company focused on improving treatment of acute myocardial infarction (AMI), announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its SuperSaturated Oxygen (SSO2) Therapy. SSO2 Therapy provides interventional cardiologists with the first and only FDA-approved treatment beyond percutaneous […]
