The Latest Cardiac and Vascular News
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 functions of all semi and automated defibrillators. This revolutionary compact, […]
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 designation to sotatercept for the treatment of patients with pulmonary […]
SEATTLE, Sept. 6, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the 14-Day version of the Carnation Ambulatory Monitor (“CAM™”), the industry’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia […]
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 received approval from the U.S. Food and Drug Administration (USFDA) […]
SANTA CLARA, Calif., Sept. 03, 2019 (GLOBE NEWSWIRE) — Shockwave Medical, Inc., a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, today announced that the company has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Shockwave […]
TAMPA, Fla.–(BUSINESS WIRE)–Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in hemodialysis treatment of renal failure. The FDA received Concept […]
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of FARXIGA (dapagliflozin) to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease (CKD). The FDA’s Fast Track program is designed […]
TEL AVIV, Israel, Aug. 26, 2019 /PRNewswire/ — Biobeat, a bio-medical technology company developing advanced sensing and remote monitoring solutions for patients, announced today that the U.S. Food and Drug Administration (FDA) has granted a 510K clearance for its patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term […]
AWANS, Belgium–(BUSINESS WIRE)–Miracor Medical SA (Miracor Medical) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its PiCSO® Impulse System for treatment of STEMI patients. The FDA Breakthrough Device designation is intended to speed time to market for treatments of life-threatening or irreversibly debilitating diseases […]
SILVER SPRING, Md., Aug. 16, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronization therapy. The FDA gave the device […]
