Surgalign receives FDA clearance for surgical guidance system

Posted1/18/2022 3:27 PM

DEERFIELD -- Surgalign Holdings Inc. said Tuesday it has received initial U.S. Food & Drug Administration clearance for its HOLO Portal surgical guidance system for use within lumbar spine procedures.

"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," said Terry Rich, Surgalign's president and chief executive officer. "With clearance in hand for our guidance application, our near-term focus is getting the platform into the hands of surgeons as we work toward a market release."


The HOLO Portal system is the world's first artificial intelligence-driven, augmented reality guidance system for spine surgery and the first clinical application of Surgalign's HOLOTM AI digital health platform, the company said.

"While the current capabilities of the HOLO Portal system have the potential to offer a quantum leap in the way surgical procedures are performed, we have a much larger vision for our HOLO AI digital health platform across a variety of health care specialties and throughout the care continuum," Rich said.

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