Surgalign seeks FDA clearance for AR spine surgery system

Spinal Tech

Surgalign Spine Technologies has submitted a premarket notification 510(k) to the FDA for approval of its digital surgical guidance system.

Six notes:

1. The surgical guidance system combines optical-based guidance technology with augmented reality, "intelligent" spine segmentation and surgical planning using artificial intelligence, the company said in a May 10 news release.

2. The device has the ability to color code the patient's organs so spine surgeons can see the organs as if they were not covered by skin, muscles and connective tissue.

3. Patients' anatomies are quickly identified to help surgeons plan procedures and accurately place pedicle screws.

4. "The Surgalign system is the first transformational innovation I’ve seen in the digital realm," said Greg Anderson, MD, clinical director of the spine section of the orthopedic research laboratory at Rothman Orthopaedic Institute in Philadelphia. "Its unique combination of AR/AI will not only allow me to make better decisions for my patients, but will allow me to deliver more accurate and efficient care in the surgical environment."

5. Surgalign acquired the device from Holo Surgical in an October deal.

6. Surgalign CMO and spine surgeon Kris Siemionow, MD, PhD, is responsible for the development of the technology.

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