Moon Surgical Receives FDA Clearance for Maestro™ Connectivity and Predetermined Change Control Plan for AI-Powered ScoPilot®
With this clearance, Maestro Systems can now have active Wi-Fi [...]
Exo Launches a New Era in Disease Diagnosis with the First FDA-cleared Ultrasound AI for Detection of Pleural Effusion and Consolidation/Atelectasis
Exo Iris® now automatically detects and localizes key pulmonary findings [...]
Expanding Innovations Receives FDA Clearance for N-GAGE™ Lumbar Plate System
The modular, low-profile construct offers spine surgeons a flexible fixation [...]
TYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System
A flowable bio-gel to protect healing tissue and preserve function.
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 [...]