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 [...]
FDA Approves LANCELOT Technology for Corcym’s Perceval Plus, Enhancing Performance of Sutureless Aortic Valve Replacement
Lancelot Technology: CORCYM , the medical device company dedicated to [...]
FDA Approves Genentech’s TNKase® in Acute Ischemic Stroke in Adults
TNKase is delivered as a single five-second intravenous (IV) bolus, [...]
Co-Diagnostics Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance
The decision by Co-Diagnostics to withdraw the submission was based [...]