Medtronic Gets 510(k) Clearance for Spine Analyzer

The FDA granted Medtronic 510(k) clearance for the latest version of its UNiD spine analyzer, an artificial intelligence-based software tool to help surgeons plan for lower lumbar spine surgeries.

The version 4.0 software includes a new algorithm for degenerative spine procedures that helps surgeons achieve spinal alignment by more accurately planning procedures and predicting the alignment after six months.

The UNiD platform draws on 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, the company said.

Medtronic said it plans on incorporating more case data and further developing the spine analyzer’s predictive algorithms.