The Latest Cardiac and Vascular News
FDA approval results in the only label of its kind for more than 3 million patients in the United States, significantly expanding AtriCure’s addressable market Superiority trial showed a 29% difference in effectiveness at 12 months and a 35% difference in effectiveness at 18 months for long-standing persistent Afib patients. Study […]
Giving IMS a First Mover Advantage – The Only 100% Cloud-Based FDA Cleared Cinematic Solution on the Market TORONTO, April 28, 2021 /PRNewswire/ — International Medical Solutions (“IMS”), one of the first cloud-native technologies to enable the remote, seamless, and instant view of medical DICOM images in the cloud received FDA Class II […]
Patient Enrollment to Begin Within Three Months FREMONT, Calif. and OXFORD, United Kingdom, April 21, 2021 /PRNewswire/ — Cerus Endovascular Ltd., a privately held, commercial-stage medical device company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to conduct a U.S. trial for the Contour […]
First Patient Receives New Shield Surface Modification, An Advance in Flow Diversion Therapy, at NYU Langone Health DUBLIN, April 21, 2021 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received approval from the United States Food and Drug Administration (FDA) for Pipeline™ Flex Embolization Device […]
Intuitive, optical-based technology system now available around the world LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for B-Capta®, the new in-line, blood-gas monitoring system integrated into the market-leading S5® heart-lung machine (HLM). The system is […]
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 […]
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 […]
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 […]
