THE WOODLANDS, Texas and REGENSBURG, Germany, Aug. 1, 2023 /PRNewswire/ — The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares […]
Tag: FDA
FDA Grants Clearance for UltraSight’s AI-Powered Cardiac Ultrasound Technology
TEL AVIV, Israel, July 27, 2023 /PRNewswire/ — Today, UltraSight, a digital health pioneer transforming cardiac imaging through the power of artificial intelligence, announced that it has been granted FDA clearance for its AI-powered ultrasound guidance technology. The UltraSight real-time AI guidance software […]
FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform
THE WOODLANDS, Texas and REGENSBURG, Germany, July 25, 2023 /PRNewswire/ — The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares […]
FEops Receives FDA Clearance for Its AI-Based Anatomical Analysis Capabilities
Enabling a time-efficient workflow and better-informed clinical decision making for structural heart interventions GENT, Belgium–(BUSINESS WIRE)–FEops announced today its new release of FEops HEARTguide™, including an AI-based anatomical analysis of MSCT images for the pre-operative planning of structural heart interventions. […]
Anumana Receives U.S. FDA Breakthrough Device Designation for its Cardiac Amyloidosis Algorithm
Developed in collaboration with Mayo Clinic, with support from Pfizer, this ECG-AI algorithm aims to aid physicians in earlier identification of cardiac amyloidosis CAMBRIDGE, Mass.–(BUSINESS WIRE)–Anumana, Inc., a leading AI-driven health technology company, has received Breakthrough Device Designation from the […]
Surmodics Receives FDA Approval for the SurVeil™ Drug-Coated Balloon
Surmodics to receive $27 million milestone payment from Abbott EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced the receipt of U.S. Food and Drug […]
FDA Approves Innovative 4D Flow MRI Blood Flow Analysis Software from Cardio Flow Design Inc. (Japan) – Enhance Cardiovascular Diagnostic Accuracy
SAN FRANCISCO–(BUSINESS WIRE)–The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI […]
LEXICON ANNOUNCES FDA APPROVAL OF INPEFA™ (SOTAGLIFLOZIN) FOR TREATMENT OF HEART FAILURE
INPEFA granted broad label across full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or without diabetes INPEFA reduced the risk of total occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart […]
Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation
The Librexia program evaluating milvexian is unrivaled as the most comprehensive factor XIa inhibitor clinical development program to date and will provide extensive data from nearly 50,000 patients, with all three studies underway RARITAN, N.J., May 25, 2023 /PRNewswire/ — The Janssen Pharmaceutical […]
Artivion Announces FDA PMA Approval of PerClot and Transfer of PMA to Baxter
Artivion to Receive $18.75 Million Milestone Payment Under Previously Announced Agreement Artivion to Begin Supplying Product to Baxter Under Transitional Manufacturing and Supply Agreement ATLANTA, May 23, 2023 /PRNewswire/ — Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced […]