Surgalign seeks FDA clearance for digital surgical guidance system

Deerfield-based Surgalign Spine Technologies announced it has submitted a premarket notification 510(k) to the U.S. Food & Drug Administration (FDA) for its digital surgical guidance system.

Surgalign is seeking its first FDA clearance for a hardware and software system that provides intuitive visualization of the patient's internal anatomy and real-time surgical guidance based on intraoperative 3D scans. The system combines optical-based guidance technology with augmented reality (AR), "intelligent" spine segmentation and surgical planning utilizing a proprietary artificial intelligence (AI) platform.

Surgalign's product is the result of six years of development and testing at Holo Surgical, Inc., by virtual and augmented reality expert Prof. Cristian Luciano, Ph.D.; spine surgeon Dr. Kris Siemionow, MD, Ph.D.; and Prof. Paul Lewicki, Ph.D., a pioneer in artificial intelligence and predictive analytics. Surgalign acquired Holo Surgical in October of 2020.