The Latest Cardiac and Vascular News
PocketECG, MediLynx’s FDA approved remote monitoring systems: PocketECG Unified Arrhythmia Diagnostic System will be used for continuous streaming and analysis of full-disclosure ECG data, oxygen saturation, resting heart rate, patient symptoms and arrhythmia. The device is cleared by the FDA for the use of its data to analyze, measure and […]
First and Only Treatment to Reduce Heart Muscle Damage Following Angioplasty and Stenting CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL® Medical Corporation, an Asahi Kasei Group company that manufactures medical devices and related software solutions, announced today it has received U.S. Food and Drug Administration (FDA) approval of the second-generation TherOx System, which provides SuperSaturated […]
New Technology on the Vantage Galan 3T Can Help Clinicians Reduce Scan Times TUSTIN, Calif.–(BUSINESS WIRE)–Physicians can now scan faster with the newly FDA-cleared Compressed SPEEDER technology from Canon Medical Systems USA, Inc. Available on the Vantage Galan 3T MR system, Compressed SPEEDER technology speeds up MRI scan times by reconstructing full resolution images […]
Vantage Galan 3T the First System in the MR Portfolio with Access to Advanced intelligent Clear-IQ Engine (AiCE) TUSTIN, Calif.–(BUSINESS WIRE)–Canon Medical Systems USA, Inc. has received 510(k) clearance on its Advanced intelligent Clear-IQ Engine (AiCE) for the Vantage Galan 3T MR system, further expanding access to its new Deep Learning Reconstruction (DLR) […]
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 […]
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 […]
– 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 […]
