The FDA has provided 510(k) clearance for Medtronic's UNiD Spine Analyzer v4.0 planning platform, which includes a new Degen Algorithm for degenerative spine procedures.
The algorithm uses machine learning to help surgeons plan and customize surgeries for patients undergoing lower lumbar spine surgery and predicts spinal compensation mechanisms six months after the operation, the company said in a July 14 news release.
The technology also upgraded its pediatric and adult deformity algorithms predicting compensatory changes to the spine. It also features a UNiD Hub patient-centric platform that allows surgeons to track patients throughout perioperative care and assess surgical results through long-term radiographic and patient-reported outcomes data collection.
"Patient by patient, our UNiD Lab engineers have learned from more than 10,000 spine surgery cases to deliver greater insights to surgeons that lead to better patient alignment," Dan Wolf, vice president and general manager of intelligent data solutions within Medtronic's cranial and spinal technology business, said in the release. "It is truly exciting to share that we have expanded our UNiD [Adaptive Spine Intelligence] technology to include hardware and software solutions dedicated to helping spine surgeons treat degenerative spinal pathologies, where the majority of spine surgery is performed."
Medtronic said it is the first and only company to have FDA cleared predictive models for spine surgery. The company aims to develop the technology with more case data and refine predictive algorithms to make spine surgery more predictable.