The Latest Cardiac and Vascular News
MIAMI, March 11, 2021 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, announced today that the U.S. Food & Drug Administration (FDA) has granted expanded access approval for the administration of Longeveron’s investigational cell […]
Cloud-Based ECG Service Provides Continuous Monitoring and Full Disclosure Reports for Clinical Diagnostics SAN FRANCISCO, March 11, 2021 /PRNewswire/ — Qardio, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510k clearance for its QardioCore ambulatory ECG device. QardioCore will initially be marketed for holter monitoring applications, for use with […]
Biodegradable Polymers Expand Options for Peripheral Embolization SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of innovative therapies for cardiovascular and neurovascular markets, announced CE Mark Approval for the IMPEDE-FX RapidFill™ Device, an expansion of the IMPEDE family of biodegradable peripheral vascular embolization plugs. Ted Ruppel, President and CEO of […]
NYON, Switzerland, March 4, 2021 /PRNewswire/ — MedAlliance, the first drug-eluting balloon (DEB) company in the world to receive US Food and Drug Administration (FDA) Breakthrough Device Designation Status for a sirolimus DEB, has now been awarded breakthrough status for SELUTION SLR™, its sustained limus release DEB catheter, in the treatment of atherosclerotic lesions […]
ATLANTA, March 4, 2021 /PRNewswire/ — ControlRad, Inc., a privately held medical technology company focused on dramatically reducing unnecessary radiation exposure during fluoroscopically guided procedures, has announced the U.S. Food and Drug Administration (FDA) 510(k) clearance to market ControlRad Select. The technology utilizes proprietary semi-transparent filters, a user-interface tablet, and image processing algorithms, […]
Pioneering technology has demonstrated potential to improve safety for patients with paroxysmal atrial fibrillation and simplify procedures for physicians MENLO PARK, Calif., March 3, 2021 /PRNewswire/ – FARAPULSE Inc. today announced the first patients were treated in the ADVENT Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial to […]
Bloomington, Ind. — Cook Medical’s Zenith® Fenestrated+ Endovascular Graft (ZFEN+) product has received Breakthrough Device designation from the US Food and Drug Administration (FDA). This designation is granted for devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. While the […]
TEL AVIV, Israel, March 1, 2021 /PRNewswire/ — Vascular Grafts Solutions (VGS) Ltd. announced today receipt of marketing clearance from the Food and Drug Administration (FDA) for the VIOLA™, a new device for clampless proximal anastomosis in coronary artery bypass grafting (CABG) Neurocognitive dysfunction remains the most devastating perioperative complication of CABG […]
PORTLAND, Ore., Feb. 23, 2021 /PRNewswire/ — Inovise Medical today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its AUDICOR® heart failure management system. The system uses clinically tested algorithms to detect the risk of decompensation at home in patients who have been previously hospitalized for heart failure. […]
LEUVEN, Belgium and BOSTON, Feb. 23, 2021 /PRNewswire/ — icometrix, world leader in imaging AI solutions for people with neurological conditions, announced the addition of icobrain cva, a stroke solution, to the icobrain portfolio. The announcement follows the FDA-clearance and CE-marking of its image processing software for the analysis and communication of the tissue perfusion state […]
