The Latest Cardiac and Vascular News
PARIS–(BUSINESS WIRE)–LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption for […]
SAN DIEGO, Sept. 17, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has named AnaBios the recipient of a grant to further develop its unique drug discovery platform utilizing muscle cells from the human heart (cardiomyocytes). Funds from the grant will […]
CARMAT provided sufficient data to support the initiation of a human clinical study Study to include 5 patients in selected renowned US institutions CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming […]
VANCOUVER, Sept. 12, 2019 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today highlighted that the U.S. Food and Drug Administration (FDA) has accepted for review United Therapeutics Corporation’s (NASDAQ: UTHR) New Drug Application […]
CAESAREA, Israel, Sept. 12, 2019 /PRNewswire/ — V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. Food and Drug Administration (FDA) has granted the company a second Breakthrough Device Designation – the first […]
SUNNYVALE, Calif.–(BUSINESS WIRE)–EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted BreakthrouThe FDA created this designation and its associated program in 2017 […]
– Designation facilitates more rapid approval and reimbursement for a breakthrough technology that offers significant advantages over current PAH treatment options – TEL AVIV, ISRAEL (PRWEB) SEPTEMBER 06, 2019 SoniVie, an Israeli company developing a novel system for the treatment of […]
FARMINGDALE, N.Y., Sept. 9, 2019 /PRNewswire/ — Leading biomedical test-instrument manufacturer Netech announced today the launch of its new state-of-the-art defibrillator/pacemaker analyzer—the Delta 3300. Recently approved by the FDA 510(k), the Delta 3300 is a precision instrument for testing and validating the […]
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug […]
NOBLES MEDICAL TECHNOLOGIES II, INC. (NMT2) ANNOUNCED TODAY THE APPROVAL BY THE U.S. FDA OF ITS IDE OF NOBLESTITCH™ EL FOR PFO CLOSURE FOR REDUCTION OF RECURRENT ISCHEMIC STROKE FOUNTAIN VALLEY, Calif., Sept. 5, 2019 /PRNewswire/ — Nobles Medical Technologies II has […]
