The Latest Cardiac and Vascular News
BAUDETTE, Minn., Oct. 31, 2019 /PRNewswire/ — ANI Pharmaceuticals, Inc. (“ANI”) (Nasdaq: ANIP) today announced that its partner Pharmaceutics International Inc. (Pii) has received FDA approval of a Prior Approval Supplement for Bretylium Tosylate Injection, USP 500mg/10ml (50mg/ml). ANI plans to launch this currently unavailable drug in December, introducing this critical drug for the treatment of ventricular fibrillation and life-threatening […]
Commercial-Ready Device to Deliver Improved Outcomes to Heart Failure Patients MOUNT LAUREL, N.J.–(BUSINESS WIRE)–Impulse Dynamics, developer of the implantable Optimizer Smart System for delivering CCM™ (Cardiac Contractility Modulation) therapy, announced today that it has received FDA approval of a PMA supplement for its next generation, two-lead Optimizer Smart System for […]
Sundance™ Sirolimus-Coated Balloon will receive prioritization throughout the FDA submission and review process to provide patients and physicians timely access to medical devices 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, today announced that the United […]
LOS ALTOS, Calif.–(BUSINESS WIRE)–HeartVista, a pioneer in AI-assisted MRI solutions, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration to deliver its AI-assisted One Click™ MRI acquisition software for cardiac exams. Despite the many advantages of cardiac MRI, or cardiac magnetic resonance (CMR), its use […]
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 […]
