The Latest Cardiac and Vascular News
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 […]
RALEIGH, N.C., April 16, 2021 /PRNewswire/ — Contego Medical, Inc., a leading developer of innovative cardiovascular devices, today announced receipt of CE Mark approval for the Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System). The patented Neuroguard IEP System contains a novel, next-generation nitinol stent, a […]
MONMOUTH JUNCTION, N.J., April 19, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care leader whose flagship E.U. approved CytoSorb® blood purification technology is intended to treat deadly conditions in critically-ill and cardiac surgery patients, announces that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its investigational device exemption (IDE) application for […]
Aquilion ONE / PRISM Edition Now Offers AI Powered Spectral Capabilities for Cardiac Exams TUSTIN, Calif.–(BUSINESS WIRE)–Meeting the growing cardiovascular needs of healthcare providers today, Canon Medical Systems USA, Inc. announces that its Deep Learning Spectral CT has received 510(k) clearance for expanded capabilities into cardiovascular applications. Available on the company’s Aquilion ONE […]
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 […]
