IRVINE, Calif.–(BUSINESS WIRE)–Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that it has received approval from the United States Food and Drug Administration (FDA) for the Alto™ Abdominal Stent Graft System (Alto). The Company received approval based on its […]
Regulatory
SynCardia Systems, LLC. 50cc temporary Total Artificial Heart (TAH-t) Now FDA Approved
TUCSON, AZ, March 09, 2020 (GLOBE NEWSWIRE) — With the FDA approval of the SynCardia Systems, LLC 50cc TAH-t system a greater number of cardiac transplant eligible patients at risk of imminent death from biventricular failure now have access to total artificial heart therapy. The 50cc TAH-t is 37.5% smaller […]
AltaThera Pharmaceuticals Announces FDA Approval for New Indications of Sotalol IV: A New and Faster Way to Initiate Sotalol Therapy for Atrial Fibrillation (AFib) Patients
– 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 […]
FDA Inks Research Collaboration Agreement with AnaBios Focused on Human Primary Cardiomyocytes
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) […]
Stereotaxis Earns FDA Clearance and Announces U.S. Launch of Genesis Robotic Magnetic Navigation System
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 […]
V-Wave Receives CE Mark for the Ventura™ Interatrial Shunt System
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 […]
Masimo Announces FDA Clearance of Continuous RRp® Monitoring
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 […]
LivaNova Receives FDA Clearance for 3T Heater-Cooler Device Modification
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 […]
CHF Solutions receives 510(k) clearance for Aquadex SmartFlow™ system in Pediatric Patients Weighing 20kg or More
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 […]
Esperion Announces FDA Approval of the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine
– 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, […]
