FDA 510(k) clearance for next-generation UNiD Spine Analyzer with degenerative spine surgery predictive model.-Medtronic

The algorithm leverages machine learning to help surgeons plan and personalize procedures for patients undergoing lower lumbar spine surgery and predicts spinal compensation mechanisms six months after the operation.

This new update also includes enhancements to the pediatric and adult deformity algorithms predicting compensatory changes to the spine. Medtronic is the first and only company to have FDA cleared predictive models for spine surgery.

The release comes with a new UNiD Hub patient-centric platform that enables surgeons to track patients throughout the perioperative care pathway and assess surgical results through long-term radiographic and patient-reported outcomes data collection.

Degenerative spine disease is a common health condition and significant cause of disability for many patients worldwide. The UNiD ASI Degen Algorithm helps surgeons achieve spinal alignment by more accurately planning procedures and predicting spinal alignment after six months. Surgical planning, using the UNiD Spine Analyzer, is especially important for degenerative spine procedures, as studies suggest nearly a third of these degenerative patients have a hidden deformity. A study suggests that when sagittal alignment is not achieved during these procedures, patients are at 10 times greater risk of experiencing degeneration of discs above or below the level where the operation was performed. Moreover a study shows that 62% of patients remained sagittally malaligned after their procedure, which may lead to revision surgery.

About UNiD ASI PlatformFDA clearance for next-generation UNiD™ Spine Analyzer with degenerative spine surgery predictive modelFDA clearance for next-generation UNiD™ Spine Analyzer with degenerative spine surgery predictive model:The UNiD ASI platform uses a database of more than 10,000 surgical cases to power algorithms that visualize multiple permutations, allowing surgeons to better understand their patient's alignment before surgery, customize a surgical plan and use patient-specific rods to help ensure the goals of the surgery are achieved. AI helps visualize mechanisms above and below the spine that will most likely occur based on the surgical plan in order to enhance clinical and surgical workflow and increase reproducibility.