FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDADENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- ...
Longview News-Journal1mon
FDA grants Breakthrough Device designation to Amphix Bio's bone regeneration product
announced today it has received a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for a drug-device combination product for bone regeneration. The designation ...
SeaStar Medical announces BDD from U.S. FDA CBER for SCD
SeaStar Medical (ICU) announces the receipt of a Breakthrough Device Designation, BDD, from the U.S. Food and Drug Administration’s, FDA, ...
Nasdaq1mon
SI-BONE, Inc. Announces First-In-Patient Procedures with FDA Breakthrough Device for Pelvic Fracture Fixation
TNT, which received 510(k) clearance in August 2024 and was awarded Breakthrough Device Designation by the FDA, is the first 3D-printed transiliac-transsacral screw cleared for market use in the U ...
Stockhouse4d
FDA Grants Breakthrough Device Designation for SeaStar Medical's Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
“This is our first Breakthrough Device Designation award for the SCD in a chronic indication. We appreciate the FDA’s continued recognition of the SCD’s potential to ...