FDA Grants De Novo Clearance for Reflow Medical’s Spur® Peripheral Retrievable Stent System
Reflow Medical, Inc., a leading developer of innovative medical devices [...]
MSKai Spine Imaging Software Receives FDA 510(k) Clearance for Clinical Use
Advanced software tool supports consistent, objective evaluation of lumbar spine [...]
GC Biopharma Receives FDA Approval for its U.S. Plasma Collection Center in Calexico, California
With this approval, ABO Holdings is now operating all six [...]
Carr Tech Corp Celebrates FDA 510(k) Class II Approval of FROG All-in-One Filter Needle
This transformative device advances safety and efficiency in drug preparation, [...]
Nanox Receives FDA Clearance for General Use of New Imaging System, Nanox.ARC X
First FDA clearance for Nanox.ARC X to produce tomographic images [...]
Medline Announces FDA Clearance for REFLEX HYBRID Nitinol Implants for Foot and Ankle Surgery
“REFLEX HYBRID further demonstrates our commitment to offering innovative solutions [...]
Terumo Neuro Receives FDA Approval for Carotid Stent System
This milestone marks the first dual-layer micromesh carotid stent approved [...]
U.S. FDA Grants Paige Breakthrough Device Designation for AI Application that Detects Cancer Across Different Anatomic Sites
Paige PanCancer Detect recognized by FDA as a Breakthrough Device [...]
restor3d Receives FDA Clearance for iTotal IdentityTM CR 3DP Porous Fully Personalized Total Knee Replacement System
This milestone marks a significant achievement in expanding restor3d’s knee [...]
Phantom Neuro Receives FDA Breakthrough Device & TAP Designations, Solidifying Position as a Neurotech Leader
“Receiving both of these certified designations from the FDA is [...]