Proprio, a Seattle-based surgical technology company, has achieved a significant milestone with its Paradigm AI guidance platform receiving its second major FDA 510(k) clearance. This clearance specifically includes the use of the platform for intraoperative measurements, marking a pivotal advancement in surgical precision and real-time data utilization. The Paradigm platform is designed to provide surgeons with an unprecedented level of 3D, dynamic, and segmental anatomical viewing capabilities during procedures, making it the first technology to allow surgeons to measure the success of their work in real-time.
The implications of this FDA clearance are far-reaching, primarily addressing the limitations of traditional surgical methods. Previously, surgeons had to interrupt procedures to conduct X-rays and CT scans for measurements, a process that could lead to increased risks for patients due to prolonged anesthesia and potential blood loss. In many cases, surgeons would rely on preoperative measurements for planning and then assess the success of the surgery postoperatively. Proprio's Paradigm platform eliminates these inefficiencies and risks by displaying real-time progress against preoperative plans, offering continuous and accurate measurements throughout the surgery.
The Paradigm platform integrates multiple advanced technologies, including light field imaging, computer vision, machine learning, robotics, and augmented reality. These technologies work in concert to capture high-definition images of the surgical field, which are then fused with preoperative 3D scans. This fusion creates a comprehensive, real-time map of the patient's anatomy, providing surgeons with invaluable insights and visualization tools. The AI component of the platform acts as a "co-pilot," continuously monitoring numerous parameters and providing a cognitive advancement even for experienced surgeons.
The adoption of the Paradigm platform has already begun at leading medical institutions such as Duke Health and UW Medicine. At Duke Health, the platform is used to measure spine alignment and reduce radiation exposure for surgical teams. UW Medicine utilizes the platform during spine surgery to precisely determine screw placement, eliminating the need for intraoperative radiation. These early applications demonstrate the potential for the Paradigm platform to improve surgical outcomes, reduce the need for revision surgeries, and enhance patient safety.
According to Proprio, the multimodal dataset provided by the Paradigm platform offers the most complete and factual view of surgery currently available. The company believes that this comprehensive dataset, continuously refined with surgeon input, will create new opportunities for training and clinical research. By collecting a wealth of data on surgical actions and outcomes, the platform can contribute to predictive analytics, suggesting optimal implant sizes, predicting spinal alignment, and flagging potentially problematic measurements.
The company's CEO and co-founder, Gabriel Jones, emphasized the significance of this advancement, stating that evolving from "highly educated guesswork to data-driven certainty with intraoperative measurements is game-changing." He further articulated the company's mission to reshape surgery through AI, not just by automating tasks, but by improving cognitive calibration, optimizing workflows, and reducing the risk of adverse events.
This FDA clearance marks a significant step forward in the integration of AI into surgical practices. Proprio's Paradigm platform exemplifies how AI can enhance surgical precision, improve patient outcomes, and transform the overall surgical experience for both surgeons and patients. As the platform continues to be adopted and refined, it holds the potential to set a new standard of care in surgery, making procedures safer, more efficient, and more accessible.
