FDA clears AI platform for real-time surgical measurements

Editor's Note

What is reportedly the first technology to allow dynamic, 3D, segmental visualization of anatomy during surgery earned a second 510(k) clearance from the US Food and Drug Administration, according to an April 8 press release from developer Proprio.

Designed to let surgeons measure progress during surgery without scrubbing in and out, Paradigm is akin to Google Maps for surgery, writes Alan Cohen of DCVC, a venture capitalist investor in the navigation system. “A surgeon will know with certainty whether the procedure has achieved the actual angles and placements required to provide an optimal outcome based on a pre-operative plan and what is learned during the actual surgery,” he writes, focusing particularly on opportunities to reduce variability in spine surgery.

In addition to “superpowers in visualization,” AI-driven, real-time image analysis “ensures images measurements are not missed,” Cohen continues. “The co-pilot in the surgical guidance system monitors dozens of parameters in split seconds. It double-checks your work and can help deliver unpar­al­leled accuracy, the underlying success measure of an optimal procedure.” As detailed in Proprio’s press release, intraoperative measurements normally require surgeons to step away to capture X-rays or CT scans. This can cause delays, increase anesthesia time, and increase the risk of blood loss. As a result, many relied on preoperative plans and postoperative assessments to determine success.  

Surgeons at institutions such as Duke Health and UW Medicine have already begun using the platform. The press release quotes Duke’s Dr Christopher Shaffrey, who praises the system’s ability to measure spinal alignment mid-procedure and reduce radiation exposure. Dr Rick Bransford of UW Medicine noted Paradigm’s potential to guide screw placement without intraoperative radiation, which he called a significant advancement over current navigation methods.

According to the announcement, this capability could also improve surgical training by creating a detailed, continuously refined data set based on surgeon input. Hundreds of specialists in spine, neuro, and orthopedic surgery have reportedly already contributed to the platform’s AI models.

The company also clarifies that FDA’s earlier clearance of Paradigm focused on its real-time 3D visualization; this new clearance adds intraoperative measurement functionality.