PeekMed
With this clearance, PeekMed becomes the first orthopedic planning platform to quickly generate clinical insights without manual or time-consuming steps.
Peek Health, a global leader in AI-powered orthopedic planning solutions, proudly announces that its PeekMed web software has received FDA clearance for its breakthrough automatic 2D-to-3D knee reconstruction technology. PeekMed web is the next generation in 2D-to-3D technologies, and it's the first global platform that can process data hands-off directly from the imaging center. The model efficiently generates 3D models that can be fed into automated planning, logistics, implant design, robotic execution, and many more applications to drive greater efficiency for more patients, while using plain X-rays, the standard of care for Orthopedic patients, and HCPs.
This clearance represents a major leap forward for orthopedic innovation, validating years of research and development in artificial intelligence and medical imaging. With standard imaging, surgeons can visualize accurate, patient-specific 3D knee anatomy automatically, using only standard Anteroposterior and Lateral X-rays, to plan procedures faster and more precisely.
“Receiving FDA clearance for automatic 2D-to-3D knee reconstruction is a defining moment for PeekMed and orthopedic innovation,” said João Pedro Ribeiro, CEO of PeekMed. “Referred by many as “the holy grail of orthopedics”, we are giving surgeons immediate access to 3D anatomical accuracy from standard X-rays, empowering faster, safer, and more consistent surgical planning worldwide. ‘Simplicity is the ultimate sophistication’, a sentence widely attributed to Da Vinci, and it is still true today.”
Traditionally, 3D planning has relied on CT or MRI scans, increasing cost, time, and patient radiation exposure. PeekMed’s new FDA-cleared 2D-to-3D AI technology eliminates those barriers by offering:
- Automatic reconstruction of 3D knee models from standard X-rays
- Significant reduction in radiation exposure and imaging costs over CT
- Precise anatomical visualization aligned with real surgical workflow
- The team can focus on clinical insights rather than imaging jigs and software clicks.
The feature was thoroughly tested to ensure it performs reliably and with a high level of anatomical precision. In these tests, it was able to closely match the real anatomy with over 90% accuracy, including fine contours and smaller anatomical details, not just the general shape. The results were also very consistent across different cases, with only minor variations.
“This is indeed an amazing turning point in orthopedics. For years, the industry has been searching for and attempting to efficiently extract 3D insights from plain X-rays, but only now has it been achieved. It feels like magic!” said Todd Davis, IBM of PeekMed.
Overall, the technology demonstrates high performance and is able to generate detailed and anatomically accurate 3D knee models that effectively support planning and visualization in clinical workflows, in less than 20 seconds. Unlike some existing solutions, where the 3D model of the knee is interpolated from a database of predefined knees, this technology generates a real, patient-specific, 3D representation of the knee directly from the imaging.
Following its EU MDR certification, this new FDA clearance reinforces PeekMed’s position as a trusted global partner in medical innovation, bridging European precision with American regulatory excellence. This achievement underscores the company's commitment to providing accessible, reliable, and intelligent surgical planning tools for orthopedic teams across the globe.
PeekMed web integrates seamlessly into hospital and surgical workflows, combining AI-driven automation, cloud accessibility, and clinical-grade accuracy. With both EU and U.S. approvals, PeekMed continues to set new standards in orthopedic care.
“Automation is more than technology; it's a clinical transformation. AI allows surgeons to superimpose real measurements on the pictures surgeons already form in their minds when they look at patient X-rays. And they should be able to do it in less time than it takes to get a cup of coffee,” added Patrick Henry, US General Manager of PeekMed. “This FDA clearance proves that AI can deliver accuracy, safety, and scalability to orthopedic surgery, redefining what’s possible in 3D surgical planning.”
Founded in Braga, Portugal, Peek Health develops cutting-edge preoperative planning software for orthopedic surgery. Its PeekMed web platform leverages AI and deep learning to provide surgeons with real-time, data-driven planning tools that enhance surgical precision, efficiency, and patient safety.
“More than 35,000 surgical plans have been created using PeekMed worldwide, demonstrating the impact of our technology across the globe. After more than a decade in this market, pushing innovation, this milestone reflects PeekMed’s direct contribution to improved patient outcomes, enhanced surgical workflows, and greater efficiency infield”, said João Pedro Ribeiro, CEO of PeekMed.
PeekMed is now used by leading hospitals and surgical centers worldwide, helping medical professionals plan orthopedic procedures faster, more accurately, and with complete regulatory assurance.
