The Latest Cardiac and Vascular News
IRVINE, Calif.–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) announced today that continuous RRp® (respiration rate from the photoplethysmograph) monitoring of adult and pediatric patients with Rad-97®, Radical-7®, and Radius-7® Pulse CO-Oximeters® has received FDA clearance. With this clearance, both continuous and spot-check RRp are now available in the US, supported in a variety of pulse oximetry sensors […]
LONDON–(BUSINESS WIRE)–Feb. 25, 2020– 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 a device modification to its 3T Heater-Cooler® devices. The modification includes the installation of a 3T Aerosol Collection Set, as well as testing that demonstrates the effectiveness of […]
EDEN PRAIRIE, Minn., Feb. 26, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS) today announced FDA 510(k) clearance in the U.S. of its next generation Aquadex SmartFlow console for use in adult and pediatric patients who weigh 20kg or more. The console is a simple, gentle, and smart solution for treatment of patients suffering from hypervolemia […]
– NEXLIZET Lowered LDL-C by 38 Percent Compared to Placebo when Added on to Maximally Tolerated Statins – – First Non-Statin, LDL-Cholesterol Lowering Combination Medicine Ever Approved – – Esperion’s Second Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in the U.S. Following NEXLETOL™ (bempedoic acid) Tablet Approval on February 21, […]
ENGLEWOOD, Colo., Feb. 25, 2020 /PRNewswire/ — Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabilitation, cardiac monitoring and neurological diagnostics, today announced the U.S. Food and Drug Administration (“FDA”) granted 510(k) clearance for sale in the U.S. for […]
Completion of Series B Financing Round Strengthens and Readies the Company for Commercialization of Two Products During the Second Quarter of 2020 FREMONT, Calif. and OXFORD, England, Feb. 21, 2020 /PRNewswire/ — Cerus Endovascular Ltd., a privately-held, commercial stage medical device company, today announced that it has now successfully completed its Series B financing having […]
Cardiovalve becomes first privately held company to receive FDA’s early feasibility study (EFS) approval for both tricuspid regurgitation (TR) and mitral regurgitation (MR) indications OR YEHUDA, Israel–(BUSINESS WIRE)–Cardiovalve announced today that it has received U.S. Food and Drug Administration (FDA) approval for an Early Feasibility Study (EFS) of its Transcatheter Tricuspid Valve […]
SOUTH JORDAN, Utah, Feb. 20, 2020 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, announced today that regulatory clearances have been issued with respect to four products Merit owns or holds the rights […]
Spectral CT with Advanced intelligent Clear-IQ Engine (AiCE) Empowers Physicians with Deep Intelligence to Enable Routine Confident Diagnoses TUSTIN, Calif.–(BUSINESS WIRE)–Canon Medical Systems USA, Inc. has received 510(k) clearance for the Aquilion ONE / PRISM Edition, enabling Deep Learning Spectral capabilities that allow for more routine spectral imaging. Designed for deep […]
Breakthrough Technology Enables Super-Fast Electrical Mapping and Re-Mapping of the Entire Heart Chamber – Leading to Rapid, Efficient and Individualized Ablation Strategies CARLSBAD, Calif., Feb. 18, 2020 /PRNewswire/ — Acutus Medical today announced FDA clearance and CE Mark of SuperMap – a revolutionary addition to its AcQMap 3D Imaging and Mapping System. SuperMap is […]
