The US Food and Drug Administration (FDA) has granted a second 510(k) clearance to Proprio for its artificial intelligence (AI)-powered Paradigm surgical guidance platform, authorising the use of intraoperative measurements.
This update allows for dynamic, three-dimensional, segmental visualisation of anatomical structures during surgical procedures. It represents the first regulatory approval enabling surgeons to evaluate surgical outcomes in real time while operating.
Before this clearance, the surgical community had limited options for measuring progress during procedures, said Proprio. Surgeons typically relied on preoperative plans and postoperative assessments to determine whether clinical objectives had been met.
Intraoperative imaging required the surgeon to temporarily exit the sterile field for X-rays or CT scans, a process that prolonged surgical time, increased anaesthesia exposure, and resulted in greater blood loss.
Paradigm now enables real-time, intraoperative assessment by continuously aligning surgical data with preoperative plans.
Surgeons receive live updates on their progress and are immediately notified upon reaching planned anatomical targets. According to the company, this development may help reduce the number of revision surgeries and enhance procedural outcomes.
The system integrates a multimodal data suite captured during surgery and synchronises it with preoperative imaging. This platform incorporates surgeon expertise into the feedback loop, producing a continuously improving dataset.
Proprio stated that hundreds of spine, neurosurgery, and orthopaedic specialists have contributed to training its AI models, creating a cumulative digital record for clinical research and education.
Proprio CEO and co-founder Gabriel Jones said: “Evolving from highly educated guesswork to data-driven certainty with intraoperative measurements is game-changing.
“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, optimising 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.”
The Paradigm platform combines intraoperative data capture with advanced visualisation capabilities using light field technology, marking a departure from conventional surgical navigation systems.
Its sensor suite collects high-definition data during surgery and fuses it with prior imaging, offering volumetric insights without interrupting workflows or exposing patients to radiation.
Proprio initially secured FDA clearance for Paradigm in April 2023. The Seattle-headquartered medical technology company designed the system to replace traditional navigational tools that can divert attention from the surgical field.
With this second authorisation, Paradigm becomes the first AI-driven system to offer continuously updated intraoperative measurements and 3D views of anatomical structures without workflow disruption.
The company stated that the platform’s continuously labelled dataset, integrated with real-time surgeon feedback, forms a basis for future applications in surgical education and clinical validation. This dataset is designed to serve as a foundation for further AI developments in surgical support and evidence-based learning.
