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

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Surgalign HOLO Portal

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. 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.”

The HOLO Portal system combines machine learning-based image guidance technology with AR, automated spine segmentation and automated surgical planning utilising proprietary AI software. Intraoperative images are autonomously processed by the AI system to create a patient-specific plan that is presented to the surgeon using the AR display.

Greg Anderson, professor in the Departments of Orthopaedic and Neurological Surgery at Thomas Jefferson University (Philadelphia, USA) and Clinical Director of the Spine Section of the Orthopaedic Research Laboratory at the Rothman Institute (Philadelphia, USA), added: “HOLO Portal is the first substantial innovation I’ve seen in the years of utilising digital technology in my practice.

“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 result of six years of development and testing at Holo Surgical——which Surgalign acquired in October 2020—by Cristian Luciano (Chicago, USA), Kris Siemionow (Miami, USA) and Paul Lewicki (Tulsa, USA).

“I recognise the power associated with HOLO technology, specifically the machine learning and AI algorithms and their ability to revolutionise healthcare,” said Lewicki. “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.”

Siemionow added: “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 visualisation.

“When physicians use HOLO, they will realise 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.”


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