Medicrea Gains First and Only FDA Nod for Patient-Specific Spinal Cages (press release)
The algorithmic generation of patient-specific cages within the UNiD HUB’s Analyzer tool is achieved using proprietary methods based on measurements around X-ray or MRI patient imaging.
The Medicrea® Group (Euronext Growth Paris: FR0004178572 - ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered spinal device design with UNiD ASI™ (Adaptive Spine Intelligence) technology, announced today that it has obtained the first and only 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market patient-specific spinal cages through the extension of its UNiD™ technology to select from its IB3D™ range of 3D-printed titanium interbody devices.
With this world-first clearance, Medicrea is able to digitally plan, manufacture in-house and supply a 3D-printed device in the United States that has been optimized to follow each patient’s unique spinal anatomy using the Company’s proprietary AI-driven UNiD technology.
The current treatment method involves a time-consuming process where surgeons implant a cage from a limited range of standard dimensions durin...
