The Latest Cardiac and Vascular News
GENT, Belgium–(BUSINESS WIRE)–FEops today announced that it received authorization from the U.S. Food and Drug Administration (FDA) for FEops HEARTguide™ pre-operative planning of left atrial appendage occlusion (LAAo) with the Abbott’s Amplatzer™ Amulet™ and Boston Scientific’s Watchman FLX™ device*. FEops HEARTguide is a one-in-its-kind cloud-based procedure planning solution in the structural […]
TEL AVIV, Israel, March 31, 2022 /PRNewswire/ — Radiaction Medical Ltd. (“Radiaction”), an innovative medical device company focused on radiation protection in the interventional cardiology and electrophysiology sectors, announced FDA 510(K) clearance for the marketing of its Shield System in the US. In addition, the company has completed a $10 million round of financing led by […]
IRVINE, Calif., March 31, 2022 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) today announced it received approval from the U.S. Food and Drug Administration (FDA) for the MITRIS RESILIA valve, a tissue valve replacement specifically designed for the heart’s mitral position. The MITRIS RESILIA valve has a saddle-shaped sewing cuff that mimics the asymmetric […]
Bloomington, Ind. — Cook Medical’s Zenith® Thoraco+ Endovascular System (Thoraco+) has received Breakthrough Device Designation from the US Food and Drug Administration (FDA). This designation is granted to devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. While the product is […]
With Respiratory Rate and Body Temperature Now Cleared, Biobeat is Leading the Medical Grade Remote Patient Monitoring Market PETAH TIKVA, Israel, March 28, 2022 /PRNewswire/ — Biobeat, a global leader in wearable remote patient monitoring solutions for the healthcare continuum, announced today that its wearable remote patient monitoring device have received 510(k) clearance from […]
DARESBURY, England, March 25, 2022 /PRNewswire/ –Sky Medical Technology Ltd (Sky) has today announced it has achieved further U.S. Food and Drug Administration (FDA) 510(k) clearance to market the new (W3) geko™ device variant, for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischemia. This latest […]
The studies will assess the performance of its HLT Meridian® TAVR® Valve System to treat aortic stenosis and aortic regurgitation for high-risk patients suffering from aortic disease MAPLE GROVE, Minn., March 24, 2022 /PRNewswire/ — HLT Inc., a Bracco Group Company and a leader in the development of cutting edge transcatheter aortic valve replacement (TAVR) therapy, […]
– Company Announces Expansion of its Contour Neurovascular System™ Platform – FREMONT, Calif. and OXFORD, England, March 23, 2022 /PRNewswire/ — Cerus Endovascular Ltd., a privately held, commercial-stage medical device company, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its 027 micro-catheters, available in two lengths, expanding […]
Company Prepares for US Commercial Launch PRAIRIE VILLAGE, Kan., March 22, 2022 /PRNewswire/ — Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and cardiology markets, today announced it received US Food and Drug Administration (FDA) clearance for its Solus Gold Embolization Device, a next-generation product for peripheral vascular […]
March 11, 2022 Industry first integrated, diagnostic quality tele-ultrasound technology lets clinicians talk, text, screen share, and transfer control to remote colleagues in real time New functionality helps increase diagnostic confidence on compatible clients including iOS, Android, Chrome web browser and Windows Peer reviewed data on efficacy and efficiency presented at […]
