Surgalign Receives FDA Clearance for Surgical Guidance System

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.”

(Surgalign Holdings got its start as RTI Surgical, a UF startup and graduate of UF Innovate | Accelerate at Sid Martin Biotech. )

Read more about Surgalign Receives FDA Clearance for Surgical Guidance System.