The Latest Cardiac and Vascular News
– Varian’s CRA system has been designated a “breakthrough device” by the FDA because of its potential to offer a more effective treatment for select patients with refractory VT. – Technology being developed will be assessed in clinical studies as a noninvasive treatment for select patients with refractory VT. PALO […]
SEOUL, South Korea, May 25, 2021 /PRNewswire/ — Mezzion Pharma Co., Ltd. (140410.KQ) is pleased to announce today that it has received notice from the FDA that its NDA submitted on March 26, 2021 for the use of udenafil to treat SVHD patients who have undergone Fontan palliation is sufficiently complete to permit a substantive review […]
Breakthrough Designation Helps Advance Treatment Options, Targeting a Significant Unmet Need in the Treatment of CLTI. WILMINGTON, Mass., May 4, 2021 /PRNewswire/ — Micro Medical Solutions (MMS), an emerging leader in the treatment of CLTI, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its […]
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 […]
