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Home » Proprio wins another FDA nod for AI surgical guidance platform

Proprio wins another FDA nod for AI surgical guidance platform

April 8, 2025 By Sean Whooley

Proprio Paradigm Prism (1)
The Paradigm AI-powered surgical guidance system. [Image courtesy of Proprio]
Proprio announced today that it received its second FDA 510(k) clearance for its Paradigm AI guidance platform for surgery.

Seattle-based Proprio designed Paradigm to replace traditional surgical navigation technologies. Using an advanced approach, it avoids the pitfalls that pull attention away from the patient and disrupt workflows. Paradigm enables 3D, dynamic and segmental viewing of the anatomy.

The company won its first FDA clearance for Paradigm in 2023. This latest clearance includes intraoperative measurements. Proprio says it marks the first time in history that surgeons can measure success in real-time during surgery.

Paradigm can now share real-time progress against pre-operative plans with continuous, accurate measurements. It lets surgeons know when they have achieved their goals and uses real-time data to inform decisions during surgery. Proprio says it can save patients from several more revision surgeries and improve outcomes altogether.

According to the company, the multimodal dataset provided by Paradigm offers “the most complete and factual view of surgery.”

“Evolving from highly educated guesswork to data-driven certainty with intraoperative measurements is game-changing,” said Gabriel Jones, CEO and co-founder 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.”

Filed Under: 510(k), Artificial Intelligence (AI), Big Data, Featured, Food & Drug Administration (FDA), Health Technology, Imaging, Machine Learning (ML), Regulatory/Compliance, Software / IT, Surgical Tagged With: FDA, Proprio

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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