The Latest Cardiac and Vascular News
PARIS–(BUSINESS WIRE)–Sensome, the company pioneering the connected medical device revolution with the world’s smallest biological tissue sensor, announced today that it has been granted a Breakthrough Device designation by the Center of Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for its Clotild® Smart Guidewire System designed […]
– First and Only Approval to Indicate Cryoablation as an Initial Rhythm Control Strategy – Offers Safe, Effective Alternative to Antiarrhythmic Drug Therapy for the Prevention of Atrial Arrythmia Recurrence DUBLIN, June 21, 2021 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced it received U.S. Food and Drug […]
FDA action expected in October 2021 SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., June 16, 2021 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review the New Drug Application (NDA) for Tyvaso DPI™ (inhaled treprostinil) for the treatment of pulmonary arterial hypertension […]
Device is FDA IDE approved to start a clinical study in the U.S. to investigate a novel cardiac arrest treatment indication COPENHAGEN, Denmark–(BUSINESS WIRE)–Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today announced that the U.S. Food and Drug Administration (FDA) has […]
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 […]
