The first AI-driven surgical guidance platform has been given clearance in the US.
Surgeons can now access real-time 3D anatomical visualisation and measurement directly in the operating room.
Proprio reached the critical regulatory achievement with its second 510(k) clearance from the US Food and Drug Administration for the Paradigm system.
This advanced AI platform equips surgical teams with dynamic, in-the-moment insights, helping optimise procedures and streamline workflow.
By merging intelligent guidance with real-time data, the technology establishes a new benchmark for surgical care.
It aims to improve safety and efficiency, significantly advancing the integration of artificial intelligence into contemporary medicine.
The new clearance enhances the platform’s functionality by incorporating intraoperative measurements, marking a pivotal moment in surgical technology.
Gabriel Jones, CEO and co-founder of Proprio, said: ‘This is the first time in history that surgeons can measure success in real-time during surgery. Evolving from highly educated guesswork to data-driven certainty with intraoperative measurements is game-changing.’
Historically, intraoperative decision-making has relied on preoperative imaging and postoperative scans, leaving minimal opportunity for immediate assessment.
Achieving alignment or anatomical goals often remained uncertain until the patient left the operating room. Measuring progress during the procedure typically requires interruptions – scrubbing out, taking fluoroscopic or CT images, and scrubbing back in – leading to inefficiency, extended anaesthesia time, and increased risk.
With the enhanced Paradigm system, surgeons now benefit from continuous, radiation-free visualisation and measurement throughout the procedure.
According to Proprio, the platform provides real-time insights into 3D, segmental anatomy while monitoring progress against the preoperative plan. This integration of imaging and data facilitates more precise execution of surgical goals and may help decrease the incidence of revision procedures.
Academic and clinical institutions are already incorporating the technology.
Christopher I Shaffrey, a neurosurgeon and orthopaedic surgeon at Duke Health and a member of Proprio’s medical advisory board, said: ‘Duke continues to advance surgical innovation and utilise cutting-edge technologies to improve patient outcomes. Our real-time 3D visualisation enables us to measure critical outcomes like spinal alignment during procedures and reduces radiation exposure for operating teams.’
At UW Medicine’s Harborview Medical Centre, spine surgeon Rick Bransford said: ‘This technology allows us to find the right angle without intraoperative radiation precisely. This next generation will also allow us to measure real-time change in segmental alignment. Ideally, we can better care for patients and train our medical students, residents, fellows, and the next generation of surgeons.’
Along with enabling real-time measurement, the Paradigm system aggregates a comprehensive dataset of labelled surgical information, capturing techniques, outcomes, and metrics from top spine, neuro and orthopaedic surgeons.
This data infrastructure could be crucial for future surgical research, education, and AI development, according to experts.
