The Latest Cardiac and Vascular News
U.S. FDA has assigned a target action date of January 28, 2022 Application based on results from the Phase 3 EXPLORER-HCM trial PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for mavacamten, an investigational, novel, […]
MINNEAPOLIS, March 16, 2021 /PRNewswire/ — Imbio, a leading provider of artificial intelligence (AI) solutions for medical imaging analysis, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RV/LV Analysis™ algorithm. The RV/LV Analysis algorithm is a rapid, automated assessment of potential right ventricular dilation. The tool quickly and accurately measures the […]
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 […]
