Surgalign receives FDA clearance for AI-driven HOLO Portal system for spine surgery - Spinal News International

Surgalign Holdings has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its HOLO Portal surgical guidance system for use within lumbar spine procedures. According to Surgalign, the HOLO Portal system is the world's first artificial intelligence (AI)-driven augmented reality (AR) guidance system for spine and the first clinical application of Surgalign's HOLO AI digital health platform. Terry Rich, president and chief executive officer of Surgalign, said: "Receiving the initial clearance for the HOLO Portal system is a significant milestone and represents a critical step toward building the foundation of the digital surgery of the future. This system is designed to improve patient outcomes by delivering intelligent solutions to our customers, and we believe it is truly revolutionary. "With clearance in hand for our guidance application, our near-term focus is getting the platform into the hands of surgeons as we work towards a market release.