AI-powered surgical platform receives FDA clearance

AI-powered surgery platform receives FDA clearance: ©Georgii - stock.adobe.com

In an advancement for surgical technology, Proprio announced that its AI-powered Paradigm platform has received a second 510(k) clearance from the U.S. Food and Drug Administration, expanding its capabilities to include intraoperative measurements. This clearance enables surgeons for the first time to view and measure anatomy in dynamic, three-dimensional detail during a procedure—an innovation that could transform how surgeries are performed and evaluated in real-time.

“This is the first time in history that surgeons will be able to measure success in real-time during surgery,” said Gabriel Jones, CEO and co-founder of Proprio. “Evolving from highly educated guesswork to data-driven certainty with intraoperative measurements is game-changing.”

Previously, surgeons had to rely on preoperative imaging and post-surgical scans to determine if they had achieved surgical goals, often without knowing the outcome until after the patient left the operating room. Taking intraoperative measurements required pausing the procedure to scrub out, take X-rays or CT scans, and scrub back in—an inefficient process that prolonged anesthesia time and increased risk.

Paradigm now allows for continuous, radiation-free visualization and measurement during surgery. According to Proprio, the platform not only displays three-dimensional, segmental anatomy but also provides real-time data on surgical progress compared to the preoperative plan. That insight helps ensure alignment goals are met and may reduce the need for revision surgeries.

Leading health systems are already incorporating the technology into their operating rooms. “Duke continues to advance surgical innovation and utilize cutting-edge technologies to improve outcomes for our patients,” said Christopher I. Shaffrey, MD, neurosurgeon and orthopedic surgeon at Duke Health and a member of Proprio’s medical advisory board. “Our use of real-time 3D visualization enables us to measure critical outcomes like spinal alignment during procedures and reduces radiation exposure for operating teams.”

At UW Medicine’s Harborview Medical Center, orthopedic surgeon Rick Bransford, MD, highlighted the platform’s potential to change how spine surgery is performed and taught. “What this technology allows us to do is precisely find the right angle without intraoperative radiation,” he said. “This next generation will also allow us to measure real-time change in segmental alignment… Not only can we ideally do a better job taking care of patients, but we can also better train our medical students, residents, fellows, and the next generation of surgeons.”

Beyond individual procedures, Proprio’s Paradigm platform is building a vast, multimodal dataset of clean, labeled surgical information, according to the company. The system captures surgical techniques, measurements, and outcomes contributed by top spine, neuro, and orthopedic surgeons, laying a foundation for future research, AI training, and education.

“Working with the best surgeons, Proprio is reshaping what's possible in surgery,” Jones said. “Our mission is to set a new standard of care that is 10 times more accessible and dramatically improves lives.”