The Latest Cardiac and Vascular News
FDA 510(k) cleared Respiration Rate analytic adds to physIQ’s growing portfolio of FDA 510(k) algorithms Clearance allows physIQ to power its higher-level AI analytics with validated vital sign inputs PhysIQ’s cloud-based analytics provide flexibility to biopharma companies and payers looking for consistent output while deploying a variety of devices across […]
An in silico clinical trial is underway with the 3DEXPERIENCE platform to evaluate the Living Heart simulated 3D heart for transforming how new devices can be tested Five-year extension of their collaborative research agreement aims to spur medical device innovation by enabling innovative, new product designs Both Dassault Systèmes and […]
FREMONT, Calif., July 17, 2019 /PRNewswire/ — Q’Apel Medical announced today that it received U.S. Food and Drug Administration clearance for its novel walrus Balloon Guide Catheter (BGC). In the neurovascular space where speed, reliability and performance are so critical to patient outcomes, physicians and patients demand that innovative technologies are best-in-class. The walrus BGC, […]
LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Advanced Circulatory Support (ACS) pump and controller, the LifeSPARC system. Derived from more than 20 years of life support experience with TandemLife, LifeSPARC […]
WHIPPANY, N.J., July 15, 2019 /PRNewswire/ — Bayer announced today the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection for use in cardiac magnetic resonance (MR) imaging to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). Gadavist is […]
ABBOTT PARK, Ill., July 15, 2019 /PRNewswire/ — Abbott (NYSE: ABT) today announced the company has received U.S. Food and Drug Administration (FDA) approval for the most advanced MitraClip™ heart valve repair device to treat mitral regurgitation. The latest approval for the fourth-generation MitraClip device, MitraClip G4, puts new enhancements into the hands of […]
LAKE OSWEGO, Ore., July 8, 2019 /PRNewswire/ — BIOTRONIK today announced FDA clearance of the BIOMONITOR III injectable cardiac monitor (ICM). BIOMONITOR III is designed to document suspected arrhythmia or unexplained syncope with increased clarity, enabling fast diagnosis and appropriate treatment. Early detection of arrhythmia through ICMs enables physician intervention before adverse outcomes occur. Atrial fibrillation […]
SCOTTSDALE, Ariz., June 28, 2019 /PRNewswire-PRWeb/ — Innovative Health, the leading single-use cardiology medical device reprocessing company, today announced it has received FDA clearance for reprocessing the market-leading PENTARAY® Nav eco High-Density mapping catheter (hereinafter PentaRay), a development that represents both a technological and healthcare cost reduction milestone. The PentaRay is a key […]
MT. OLIVE, N.J., June 26, 2019 /PRNewswire/ — Catheter Precision, Inc., announced today that the U.S. Food and Drug Administration (FDA) has cleared its new VIVO™ (View into Ventricular Onset) system for market release in the United States. VIVO is a pre-procedure planning tool that offers 3D cardiac mapping to aid in localizing […]
WASHINGTON, June 24, 2019 /PRNewswire/ — The Centers for Medicaid and Medicare Services last Friday issued their final National Coverage Decision on how hospitals will be approved to do the TAVR (transaortic valve replacement) procedure, a less invasive valve replacement treatment that avoids open heart surgery and allows patients to resume daily life […]
