Medicrea Group wins FDA clearance for AI-based spine surgery tech
The Medicrea Group has received 510(k) clearance from the U.S. Food & Drug Administration for its UNiD HUB product, a data-driven digital portal for the company’s Adaptive Spine Intelligence technology.
The new UNiD HUB is designed to support the surgeon workflow, identify tendencies and correlations, and build predictive modeling to drive intelligent strategic decisions and create personalized implant solutions for surgery, Medicrea said.
The UNiD HUB software also enhances existing proprietary IT used by Medicrea’s UNiD Adaptive Spine Intelligence platform for digital surgical planning to create a communication channel between the company’s UNiD LAB biomedical engineers and surgeon users to deliver UNiD TEK, patient-specific spinal implants manufactured by Medicrea through proprietary rod bending and 3-D printing techniques.
The digital communication portal opened with the introduction of UNiD HUB allows surgeons to track and manage their open cases in both snapshot and detailed views, access their complete history with post-operative analyses, and dialogue with a dedicated biomedical engineer in real-time, Medicrea said. Additional functions will become available alongside the software’s wide release in October 2017.