Surgalign’s HOLO Portal AI-Driven, AR Spine Surgery Guidance System Earns FDA Nod

Surgalign received U.S. Food and Drug Administration (FDA) 510(k) clearance for its HOLO Portal AI-driven augmented reality (AR) guidance system for lumbar spine procedures. It is the first clinical application for the company’s HOLO AI digital health platform.
 
“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,” Surgalign president and CEO Terry Rich told the press. “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. 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 healthcare specialties and throughout the care continuum.”
 
HOLO Portal combines machine learning-based image guidance with AR, automated spine segmentation and proprietary, automated AI surgical planning software. The AI system autonomously processes intra-op images to make a patient-specific plan shown to the surgeon on the AR display.
 
“HOLO Portal is the first substantial innovation I’ve seen in the years of utilizing digital technology in my practice,” said Dr. D. Greg Anderson, MD, PhD, and Professor in the Departments of Orthopaedic and Neurological Surgery at Thomas Jefferson University and Clinical Director of the Spine Section of the Orthopaedic Research Laboratory at the Rothman Institute. “The system’s groundbreaking combination of AR and AI will better inform surgical decisions for my patients and ultimately deliver more accurate and efficient care in the surgical environment. It is truly transformative.”
 
HOLO Portal is the culmination of six years of development and testing at Holo Surgical Inc., which Surgalign acquired in October 2020.
 
Professor Paul Lewicki, a pioneer in AI and predictive analytics and founder of one of the leading and earliest companies in predictive data mining, commented, “I recognize the power associated with HOLO technology, specifically the machine learning and AI algorithms and their ability to revolutionize healthcare. We spent years developing machine learning based neural networks to teach the computer anatomy and address specific surgical needs. The result is displayed in 3D directly in the surgeon’s field of vision using the AR display, allowing for an elegant flow of information between the system and the physician.”
 
“I believe our technology has the potential for improved patient outcomes and reduced operative time due to autonomous surgical planning and intraoperative guidance. The system displays the anatomy in 3D, which allows for less tissue damage during the surgical procedure, due to improved visualization,” added spine surgeon Dr. Kris Siemionow. “When physicians use HOLO, they will realize that the system provides them with information they may currently be missing—surgeons will quickly see how they can leverage the technology in the operating room and beyond to deliver better care.”
 
Surgalign expects global revenue of $90.2-90.6 million for 2021.