The Latest Cardiac and Vascular News
VANCOUVER and MINNEAPOLIS, April 16, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), today announced that the Tiara Transapical system (“Tiara TA”) will be unable to receive a European CE mark under the current Medical Device Directive regulations (“MDD”) ending on May 26, 2021. The Company is […]
Product Family Targets Over 300,000 Annual US Electrophysiology and Structural Heart Procedures CARLSBAD, Calif., April 13, 2021 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the FDA clearance of the AcQCross™ family […]
Thrombectomy Device with Off-Circuit Mechanical Aspiration Design for Treatment of Undesirable Intravascular Material in Venous System and Peripheral Vasculature LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology today announced that on April 9, 2021, it […]
Panel votes 12 to 5 that benefits of OCS Heart System outweigh risks ANDOVER, Mass., April 6, 2021 /PRNewswire/ — TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, announced today that after the review of TransMedics’ clinical […]
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 […]
