The Latest Cardiac and Vascular News
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq: ELGX), a developer and marketer of innovative treatments for aortic disorders, today announced a response to the U.S. Food and Drug Administration (FDA) update regarding Type III endoleaks with the AFX Endovascular AAA System. Dr. Matt Thompson, Chief Medical Officer of Endologix Inc. commented, “On […]
DUBLIN, Oct. 29, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Medtronic Fully Implantable Left Ventricular Assist Device (LVAD) for patients with advanced heart failure, currently in development. […]
CORRECTION…by Abiomed October 26, 2019 09:15 AM Eastern Daylight Time DETROIT–(BUSINESS WIRE)–Please replace the caption for release dated October 25, 2019 with the accompanying corrected caption. The release reads: FDA POST APPROVAL STUDY DEMONSTRATES TIMELY IDENTIFICATION OF RIGHT HEART FAILURE AND EARLY USE OF IMPELLA RP LEADS TO HIGHER SURVIVAL […]
BAAR, Switzerland–(BUSINESS WIRE)–CorFlow Therapeutics AG (www.corflow-therapeutics.ch) today announced that the FDA has designated the company’s CoFI (CorFlow Controlled Flow Infusion) System as a “Breakthrough Device” with a broad indication-for-use statement: “The CoFI™ System is indicated for diagnostic assessment of the coronary microcirculation immediately following PCI (“stenting”), and to be a platform for controlled infusion of therapeutic agents […]
TUSTIN, Calif.–(BUSINESS WIRE)–Canon Medical Systems USA, Inc. has received 510(k) clearance on its Advanced Intelligent Clear-IQ Engine (AiCE) for the Aquilion PrecisionTM further expanding access to its new deep convolutional neural network (DCNN) image reconstruction technology. This technology, now available on both the Aquilion Precision and Aquilion ONE / GENESIS EditionTM premium CT systems, […]
DUBLIN, Oct. 09, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) has classified the company’s voluntary field action initiated in March 2019 related to the 6F Sherpa™ NX Active Coronary Guide Catheter as a Class I recall. The catheter is used during coronary […]
TEWKSBURY, Mass., Oct. 9, 2019 /PRNewswire/ — Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its InterAtrial Shunt Device (IASD) for heart failure. The IASD is […]
IRVINE, Calif., Oct. 2, 2019 /PRNewswire/ — Laser Associated Sciences (LAS), a medical device company based in Irvine, California, announced that its blood flow monitoring system, FlowMet-R, received its 510(k) clearance from the Food and Drug Administration (FDA). This clearance allows LAS to market and sell the FlowMet-R. The non-invasive portable device addresses a […]
MALVERN, Pa.–(BUSINESS WIRE)– The U.S. Food and Drug Administration (FDA) has cleared three modules of AI-Rad Companion Chest CT¹, an intelligent software assistant from Siemens Healthineers that brings artificial intelligence (AI) to computed tomography (CT). Representing the first intelligent assistant of the new AI-Rad Companion platform, AI-Rad Companion Chest CT […]
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed’s (NASDAQ: ABMD) newest heart pump, the Impella 5.5 with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. Impella 5.5 with SmartAssist is: Minimally invasive, eliminating the need for a […]
