Zebra Medical Gains FDA 510(k) for AI Technology

By Julie A. Vetalice

Zebra Medical Gains FDA 510(k) for AI Technology

Zebra Medical Vision was granted FDA 510(k) clearance to market an artificial intelligence (AI) solution to extract bone measurements from x-ray scans, at the same quality as CT scans, for planning orthopedic surgical procedures. Zebra-Med’s novel technology, recently patented (U.S. Patent No.16/387,599), is expected to open new markets for implant surgeries in places where CT scans and MRIs are not available or affordable for such procedures.

Zebra-Med’s technology uses AI algorithms to reconstruct a 3D model of the patient's bones from standard x-ray images, providing surgeons with full-shape landmarks and measurement information accurately and affordably. Zebra-Med’s ability to create these reconstructions is based on the largest real-world, medical-image database available today.

Zebra-Med’s solution also addresses the logistical bottleneck spurred by unnecessary implants being delivered to each surgery, raising inventory and healthcare costs at large, due to limitations of existing planning solutions.

The technology may help with less common implant sizes (small or large), and for implant inventory management.

In late 2019, the company partnered with DePuy Ireland to bring AI opportunities to orthopedics, based on imaging data. Further, in 2020, the company gained a fifth FDA 510(k) clearance for its Vertebral Compression Fractures product.

“Zebra Medical Vision is proud to lead the AI medical imaging market,” said Ohad Arazi, CEO of Zebra Medical Vision. “Expanding from radiology to orthopedic surgery supports our mission of leveraging machine learning and computer vision to help patients achieve better care everywhere with more readily available resources.”

Product Labels: Surgical Planning

Tags: 510(k) Clearance, Regulatory