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Proprio Reports: 4th FDA Clearance Highlights Growing Shift to 3D Measurement in Spine Care

Picasso Experience Expands Surgeon-Controlled, Radiation-Free Registration Workflows for Real-Time Intraoperative Spinal Alignment Measurements

Proprio, the surgical technology company pioneering real-time, AI-powered intraoperative guidance and data-driven surgical workflows, today announced the U.S. Food and Drug Administration (FDA) has granted clearance for the “Picasso” feature. This marks the company’s fourth FDA-cleared capability within its Paradigm platform.

The Paradigm AI platform provides continuous, three-dimensional measurements that allow surgeons to assess spinal alignment intraoperatively. Growing clinical research has underscored the limitations of traditional two-dimensional assessment and the value of richer 3D characterization in understanding spinal anatomy and alignment.

The Picasso clearance expands Paradigm’s surgeon-controlled registration workflow, enabling trace-based optical registration within the Paradigm system to support intraoperative spinal alignment measurement across a broader range of spine procedures. This latest company milestone builds on Proprio’s radiation-free guidance foundation and reflects accelerated progress toward more precise, measurement-driven surgical workflows.

“Historically, spine surgeons have had limited ways to verify alignment during a procedure itself,” said Gabriel Jones, CEO and Co-Founder of Proprio. “As intraoperative measurement becomes more practical, surgeons are looking for tools that let them assess progress while they are operating, not after the fact. Picasso extends Paradigm’s existing 3D guidance capabilities by giving surgeons more direct control over registration at the point of care.”

Picasso is designed for surgeons seeking alternatives to radiation-dependent navigation workflows and technician-led registration processes. The radiation-free, trace-based approach allows surgeons to verify and refine registration optically, without requiring CBCT spins or restarting the workflow.

“We appreciate the FDA’s review and clearance of Picasso,” Jones added. “This milestone reflects our focus on delivering practical, surgeon-driven workflow improvements while laying the foundation for more AI-enabled capabilities.”

Proprio’s real-time intraoperative measurements add to an unprecedented collection of surgical data. With a comprehensive, multimodal dataset that has a clear view of surgery and is clean, labeled, and continuously refined with surgeon expertise in the loop, Proprio offers a highly differentiated and objective view of surgery. This can create new opportunities for training and clinical research. Hundreds of the world’s greatest spine, neuro, and orthopedic surgeons have already contributed their expertise to Proprio’s AI models, creating their digital legacy with every surgery, technique, and outcome recorded for future generations to learn from.

Surgeons and hospital systems interested in learning more about Proprio Paradigm and the newly cleared Picasso feature can visit www.propriovision.com

Other FDA news items can be found here.