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 that the U.S. Food and Drug Administration (FDA) granted premarket […]
Tag: FDA
Bayer Receives U.S. FDA Fast Track Designation for asundexian Atrial Fibrillation Program
Not intended for UK Media The OCEANIC-AF (atrial fibrillation) study with asundexian is part of the Phase III OCEANIC clinical trial program enrolling more than 27,000 patients in over 40 countries Asundexian is being evaluated as a potential improved treatment option in stroke prevention and could be part of an […]
Sequana Medical announces FDA clearance of IND application for DSR® 2.0 for treatment of congestive heart failure
MOJAVE study on track to start in Q2 2023 as planned, with initial data by year-end Randomized, controlled study in US seeking to confirm strong efficacy data seen in RED DESERT and SAHARA studies DSR well positioned as disease-modifying heart failure therapy Ghent, Belgium – 02 May 2023 – Sequana Medical NV (Euronext […]
Tenaya Therapeutics Receives FDA Fast Track Designation for TN-201
TN-201 Being Developed for the Potential Treatment of MYBPC3-associated HCM Dosing in Phase 1 Clinical Trial Expected to Commence in Q3 2023 SOUTH SAN FRANCISCO, Calif., May 02, 2023 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially […]
Abbott’s Life Support System Receives New FDA Clearances to Help Doctors Treat More Critically Ill Patients
Abbott’s CentriMag™ Blood Pump, previously cleared for use up to six hours, now can be used to provide longer-term life support to critically ill patients, providing doctors more time to make critical care decisions Abbott’s CentriMag™ Pre-connected Pack, which combines a blood pump and oxygenator to form a life support […]
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, is pleased to announce it has received FDA Premarket Approval […]
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 announced it has received FDA 510(k) clearance for Rapid NCCT […]
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 that the U.S. Food and Drug Administration (FDA) has granted […]
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 functional cardiac muscle for the treatment of patients with Duchenne […]
Getinge recieves FDA premarket approval for the iCast™ covered stent system in the US
GOTHENBURG, Sweden, March 24, 2023 /PRNewswire/ — Getinge’s iCast™ covered stent system has received premarket approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease. Iliac arterial occlusive disease is a type of peripheral arterial disease (PAD), a serious condition that only in the US […]