MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in...
California-based Toku has seen its artificial intelligence (AI) system for identifying kidney disease awarded the US Food and Drug Administration (FDA) breakthrough device designation.
The...
Route 92 Medical announced it received FDA 510(k) clearance for its FreeClimb 54 reperfusion system.
The FreeClimb54 system uses an aspiration catheter of the same...
Single Pass, Inc. is proud to announce that its Class II Kronos biopsy closure device has received clearance from the U.S. Food and Drug Administration...
ClearPoint Neuro (Nasdaq:CLPT) announced today that the FDA granted 510(k) clearance for its Prism bone anchor accessory.It marks the second new product introduction in...
Roivios has secured the US Food and Drug Administration’s (FDA) breakthrough device designation for its JuxtaFlow renal assist device (RAD), designed to provide kidney...
Sail Fusion today announced it received FDA 510(k) clearance for its BowTie Sacroiliac Fusion System.
The Del Mar, California-based sacroiliac device company designed the device...
Blue Arbor Technologies announced today that it received FDA breakthrough device designation for its Restore neuromuscular interface system.
The FDA also accepted the system into...
4D Path has secured the US Food and Drug Administration (FDA) Breakthrough Device Designation for Q-plasia OncoReader Breast, its first software-as-a-medical-device solution.
The new 4D...
