Tag: FDA

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 […]

BlackSwan Vascular Wins FDA Premarket Approval of Innovative New Treatment for Peripheral Arterial Hemorrhages

Lava® LES is the first liquid embolic product approved by the FDA for use in the peripheral vasculature HAYWARD, Calif., April 18, 2023 /PRNewswire/ — Bay Area-based BlackSwan Vascular, Inc., a privately held company that is developing innovative therapies in endovascular embolization, […]

RapidAI Receives First and Only FDA 510(k) Clearance of Non-Contrast CT Imaging Product to Accelerate Acute Stroke Triage

Part of RapidAI’s industry-leading stroke solution, Rapid NCCT Stroke supports faster treatment and transfer decisions while driving greater equity of care SAN MATEO, Calif.–(BUSINESS WIRE)–RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today […]

Genetesis Receives 2nd FDA Breakthrough Device Designation for Non-Invasive Diagnosis of Myocardial Ischemia Using CardioFlux MCG

Designation represents progress for patients with suspected Coronary Microvascular Dysfunction as the FDA recognizes disease’s debilitating impacts and the lack of effective non-invasive options for efficient diagnosis MASON, Ohio–(BUSINESS WIRE)–Genetesis, Inc., the leader in biomagnetic cardiac imaging solutions, today announced […]

IPS HEART receives FDA Rare Pediatric Drug Designations for both of its Stem Cell Drugs for Duchenne Muscular Dystrophy

HOUSTON–(BUSINESS WIRE)–IPS HEART has been granted rare pediatric drug designation by the FDA for GIVI-MPC, a first-in-class stem cell therapeutic to create new skeletal muscle with 100% full length dystrophin and for ISX9-CPC, a first-in-class stem cell therapeutic for creating new […]