Proprio Wins 2nd FDA Nod for Paradigm AI Surgical Guidance Platform

Proprio, a company focused on artificial intelligence (AI)-powered surgical technology, has received a second, major U.S. Food and Drug Administration (FDA) 510(k) clearance for its Paradigm AI guidance platform for surgery.

The new FDA nod includes intraoperative measurements. According to the company, this is the first tech to enable 3D, dynamic, and segmental anatomical viewing. It also marks the first time surgeons can measure success in real-time during surgery.

To take measurements, doctors have to scrub out and back in between taking X-rays and CT scans, leading to delays while patients were under anesthesia and losing blood. Surgeons commonly chose to keep surgery moving without delay and rely on pre-op measurements for planning and post-op measurements to see if they achieved their goals.

The Paradigm AI platform now shares real-time progress against pre-op plans with continuous, accurate measurements. It lets surgeons know when they’ve achieved their goals. Proprio believes using real-time data to inform decisions during surgery can save patients from more revision surgeries.

A comprehensive, multimodal dataset has a clear view of surgery and is clean, labeled, and continuously refined with surgeon experience in the loop. Proprio believes Paradigm will create new opportunities for training and clinical research.

“We’ve been using navigation in spine surgery for a while, but what this technology allows us to do is precisely find the right angle without intraoperative radiation and navigate it,” said Dr. Rick Bransford, a UW Medicine orthopedic surgeon at Harborview Medical Center. “The system can kind of tell us the trajectory and guidance to place screws with zero radiation. This is a big deal, as almost all other forms of navigation require some component of intraoperative radiation. This next generation will also allow us to measure real-time change in segmental alignment without intraoperative radiation.  This means that 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,” Bransford said.

“Evolving from highly educated guesswork to data-driven certainty with intraoperative measurements is game-changing,” said Gabriel Jones, co-founder and CEO of Proprio. “Working with the best surgeons, Proprio is reshaping what’s possible in surgery and transforming healthcare with AI—not just automating tasks, but improving cognitive calibration, optimizing workflows for operating teams, robotics, and devices, while reducing the risk of adverse events. Our mission is to set a new standard of care that is 10 times more accessible and dramatically improves lives. Giving surgeons the visibility and data they need precisely when they need it is a huge leap forward in achieving our goals.”

In September 2024, the company announced that its Paradigm platform had been used to complete 50 successful surgeries.