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 […]
Tag: FDA
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) […]
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, […]
Zynex Receives FDA Clearance for its Blood Volume Monitor
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 […]
Cardiovalve Receives ‘Breakthrough Device Designation’ for Its Transcatheter Tricuspid Valve Replacement System
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 […]
Merit Medical Systems Announces Four Regulatory Approvals
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 […]
RIST Neurovascular, Inc. Announces FDA Clearance of the First Catheter Specifically Designed to Access the Neurovasculature through the Radial Artery
RIST Cath device enables a radial approach during neurointerventional procedures for introduction of devices into the neurovasculature MIAMI BEACH, Fla.–(BUSINESS WIRE)–RIST Neurovascular, Inc., a neuro-interventional medtech company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the RIST Cath Radial Access Long Sheath™ (RIST […]
Aria CV Receives FDA Breakthrough Designation for Its Medical Device for Treating Pulmonary Arterial Hypertension
SAINT PAUL, Minn.–(BUSINESS WIRE)–Aria CV, Inc., a developer of medical devices treating Pulmonary Arterial Hypertension (PAH), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Aria CV Pulmonary Hypertension System (Aria CV PH System). The Breakthrough Devices Program (BDP) is intended to […]
