The Latest Cardiac and Vascular News
MASON, Ohio–(BUSINESS WIRE)–Genetesis, a medical technology company focused on using biomagnetic imaging to enable rapid, noninvasive and accurate chest pain triage, has received FDA 510(k) clearance for its cardiac imaging platform. The platform pairs the CardioFlux™ Magnetocardiograph with the integrated Faraday Analytical Cloud™ (FAC). “This milestone provides emergency room physicians […]
FRANKLIN LAKES, N.J., March 21, 2019 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued the following statement related to the recent letter from FDA to health care providers regarding paclitaxel-coated devices: On March 15, the FDA issued a letter to health care providers regarding paclitaxel-coated devices […]
ORANGEBURG, New York, March 21, 2019 /PRNewswire/ — Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today that it has received approval from the United States Food and Drug Administration for its first-in-class Optimizer Smart System (link to FDA announcement: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634103.htm). Designed to address a significant unmet […]
SILVER SPRING, Md., March 21, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat. […]
LAKE OSWEGO, Ore., March 14, 2019 /PRNewswire/ — BIOTRONIK today announced FDA approval of the Acticor and Rivacor high-voltage cardiac rhythm management (CRM) device families for treatment of patients with cardiac arrhythmias. The six new tachycardia solutions include Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor […]
FRANKLIN LAKES, N.J., March 14, 2019 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the U.S. Food and Drug Administration has granted premarket approval for the Venovo™ venous stent, the first stent indicated to treat iliofemoral venous occlusive disease, which is obstructed or narrowed blood flow […]
SILVER SPRING, Md., March 14, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved a new indication for a heart valve repair device that is intended to reduce moderate-to-severe or severe mitral regurgitation, a leakage of blood backward through the mitral valve into the heart’s left atrium that can cause […]
ABBOTT PARK, Ill., March 14, 2019 /PRNewswire/ — Abbott (NYSE: ABT) today announced it received approval from the U.S. Food and Drug Administration (FDA) for a new, expanded indication to its leading MitraClip™ device used to repair a leaky mitral valve without open-heart surgery. Supported by the results of the landmark COAPT™ Trial, […]
JACKSONVILLE, Fla. and IRVINE, Calif., March 11, 2019 (GLOBE NEWSWIRE) — Espero BioPharma, Inc., a pharmaceutical company focused on the development of therapeutics for unmet needs in thrombosis and cardiac rhythm control, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for tecarfarin […]
CHICAGO, March 6, 2019 /PRNewswire/ — Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, announced today that its development partnership with a leading medical products company has resulted in the U.S. Food and Drug Administration (FDA) approval and launch of the ready-to-use cardiovascular medication, eptifibatide. It is […]
