The Latest Cardiac and Vascular News
FLAGSTAFF, Ariz., March 30, 2021 /PRNewswire/ — Today, W. L. Gore & Associates, Inc. (Gore) announces the first use of the FDA approved GORE® EXCLUDER® Conformable AAA Endoprothesis with ACTIVE CONTROL System in cases outside of clinical trials. Cases were successfully performed by Robert Rhee, M.D. with Mahmoud Almadani, M.D., in Brooklyn, New York and by Gustavo Oderich, M.D. with Naveed Saqib, M.D., in Houston, Texas. The GORE […]
New implant device provides less invasive option to treat pulmonary valve regurgitation for patients with a native or surgically-repaired right ventricular outflow tract SILVER SPRING, Md., March 26, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult […]
TIGERTRIEVER™ uses Rapid Medical’s proprietary technology to significantly improve the effectiveness of minimally invasive clot removal in the brain YOKNEAM, Israel & MIAMI–(BUSINESS WIRE)–Rapid Medical, developer of responsive, adjustable neurovascular devices, announces the FDA clearance of its TIGERTRIEVER™ revascularization device for use in the treatment of ischemic stroke. TIGERTRIEVER is the first […]
CHICAGO–(BUSINESS WIRE)–Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food & Drug Administration (FDA) has granted the company Breakthrough Device Designation for its ECG Analysis Platform. The platform, developed in collaboration with Geisinger, aids clinicians in identifying patients at increased risk of developing atrial […]
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 […]
