The Latest Cardiac and Vascular News
– Sotalol IV is now approved for 1-day hospital outpatient initiation of AFib therapy and faster dose escalations for existing patients – New FDA-approved dosing, monitoring and evaluation shortens the hospital stay from 3 days to 1 day – The new initiation provides physicians with a faster and safe way […]
SAN DIEGO, March 10, 2020 /PRNewswire/ — Today, AnaBios announced a Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA) to study adult human primary cardiomyocytes as a reference for cellular properties and drug-induced effects on cardiac function. Under the RCA, the FDA Center for Drug Evaluation and Research (CDER) […]
ST. LOUIS, March 06, 2020 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), the global leader in innovative robotic technologies for the treatment of cardiac arrhythmias, announced today it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of the Genesis RMN® System for the robotic navigation of magnetic ablation catheters to treat heart […]
CAESAREA, Israel and AGOURA HILLS, Calif., March 5, 2020 /PRNewswire/ — V-Wave Ltd., a privately held medical device company developing novel implantable devices for the treatment of Heart Failure (HF), today announced that its Ventura™ Interatrial Shunt System received CE Mark and is now approved to be marketed for use in the European Union. “More than 26 […]
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 […]
