In a significant advancement for surgical technology, two companies have received FDA clearance for AI-powered surgical guidance platforms that promise to transform spine surgery and beyond.
Proprio's Paradigm Platform Brings Real-Time Measurement to Surgery
Proprio, a leader in AI-powered surgical technology, announced its Paradigm platform has received a second major 510(k) clearance from the FDA to include intraoperative measurements. This groundbreaking technology enables 3D, dynamic, and segmental viewing of anatomy, marking the first time surgeons can measure surgical success in real-time during procedures.
The platform addresses a critical gap in surgical workflows. Previously, surgeons had to interrupt procedures to take measurements, requiring them to scrub out and back in between X-rays and CT scans. This created significant delays while patients remained under anesthesia and continued to lose blood. Many surgeons opted to proceed without these measurements, relying instead on preoperative planning and postoperative assessments.
"Duke continues to advance surgical innovation and utilize cutting-edge technologies to improve outcomes for our patients," said Christopher I. Shaffrey, M.D., neurosurgeon and orthopedic surgeon at Duke Health and member of Proprio's medical advisory board. "Our use of real-time 3D visualization enables us to measure critical outcomes like spinal alignment during procedures and reduces radiation exposure for operating teams."
The technology also eliminates radiation exposure during procedures, a significant benefit highlighted by Dr. Rick Bransford, a UW Medicine orthopedic surgeon at Harborview Medical Center: "The system can tell us the trajectory and guidance to place screws with zero radiation. This is a big deal, as almost all other forms of navigation require some component of intraoperative radiation."
Medivis Launches AR-Powered Spine Navigation
Simultaneously, Medivis Inc. has received 510(k) clearance from the FDA for its Spine Navigation platform, which utilizes augmented reality (AR) and AI to provide holographic navigation across open and minimally invasive spine procedures. The company has announced immediate commercial availability to hospitals and ambulatory surgical centers nationwide.
"Surgery is entering a new era of advanced computing that enhances precision, speed, and efficiency in the operating room. This is a pivotal moment in medicine, and we are thrilled to deliver a solution that will elevate patient care to new heights," said Dr. Christopher Morley, President of Medivis.
The Medivis platform combines proprietary computer vision algorithms, AI segmentation, real-time data analysis, and advanced image processing to deliver precise, context-aware insights throughout surgical workflows. Its lightweight AR hardware allows surgeons to visualize critical information while maintaining focus on the operative field, with hand tracking and voice commands providing complete control.
Transforming Surgical Decision-Making with AI
Both platforms represent a shift from "educated guesswork" to data-driven surgical decision-making. Proprio's CEO and Co-Founder Gabriel Jones emphasized this transformation: "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."
The technology not only improves individual surgeries but also creates unprecedented opportunities for surgical data collection and analysis. Proprio reports that hundreds of spine, neuro, and orthopedic surgeons have already contributed their expertise to the company's AI models, creating a comprehensive dataset for future training and clinical research.
Clinical Impact and Future Directions
These technologies promise significant clinical benefits, including:
- Reduced radiation exposure for patients and surgical teams
- Decreased time under anesthesia
- Improved precision in screw placement and alignment
- Enhanced training opportunities for medical students, residents, and fellows
- Potential reduction in revision surgeries
Dr. Osamah Choudhry, CEO of Medivis, highlighted the transformative potential: "We envision a future where surgical navigation transcends boundaries by integrating imaging data with the operative field. With our recent FDA clearance for Spine Navigation, we are thrilled to equip surgeons with breakthrough technology to visually transform spine surgery."
As these platforms move into clinical practice, they represent the leading edge of a broader transformation in surgical care, where AI and advanced visualization technologies provide surgeons with unprecedented real-time information and guidance, potentially improving outcomes across a wide range of procedures.
