The Latest Cardiac and Vascular News
SILVER SPRING, Md., June 3, 2021 /PRNewswire/ — The U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device (HVAD) System due to a growing body of observational clinical comparisons that demonstrates a higher frequency of neurological adverse events and […]
IRVINE, Calif., June 1, 2021 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) today announced that Acumen Hypotension Prediction Index (HPI) software with the Acumen IQ finger cuff has received U.S. Food and Drug Administration clearance. This is the first noninvasive solution that unlocks Acumen HPI software and uses machine learning to alert clinicians of the […]
Avicenna.AI announces the introduction of CINA CHEST, including AI tools for detection and emergency triage of pulmonary embolism and aortic dissection MARSEILLE, France , June 2, 2021 /PRNewswire/ — Medical imaging AI specialist Avicenna.AI today announced that it has received certification in the United States and European Union for CINA CHEST, its new AI solution that leverages […]
MORRISVILLE, N.C., June 02, 2021 (GLOBE NEWSWIRE) — Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for LIQ861 (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH). The FDA confirmed that the resubmission was a complete, […]
NEWTOWN, Pa., May 27, 2021 /PRNewswire/ — Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA™-T Percutaneous Tricuspid Annuloplasty System. The MIA-T system treats moderate-severe tricuspid regurgitation (TR) via a 12F catheter-based system. MID develops proprietary Transcatheter Cardiac Repair (TCR) technologies addressing unmet […]
CARLSBAD, Calif., May 27, 2021 (GLOBE NEWSWIRE) — Acutus Medical (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced FDA approval for the company to initiate its Atrial Fibrillation (“AF”) Investigational Device Exemption (IDE) clinical trial for the AcQBlate Force […]
– Varian’s CRA system has been designated a “breakthrough device” by the FDA because of its potential to offer a more effective treatment for select patients with refractory VT. – Technology being developed will be assessed in clinical studies as a noninvasive treatment for select patients with refractory VT. PALO […]
SEOUL, South Korea, May 25, 2021 /PRNewswire/ — Mezzion Pharma Co., Ltd. (140410.KQ) is pleased to announce today that it has received notice from the FDA that its NDA submitted on March 26, 2021 for the use of udenafil to treat SVHD patients who have undergone Fontan palliation is sufficiently complete to permit a substantive review […]
The new Zio® monitor is designed to significantly improve patient comfort, while enhanced AI capabilities raise the bar on cardiac arrhythmia detection SAN FRANCISCO, May 24, 2021 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital healthcare solutions company focused on the advancement of cardiac care, today announced […]
Study Evaluates the Safety and Feasibility of TherOx Supersaturated Oxygen (SSO2) Therapy in STEMI Patients presenting with Cardiogenic Shock CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today the U.S. Food and Drug Administration (FDA) has approved an investigational device […]
