MARS Bioimaging has received FDA 510(k) clearance for a portable photon-counting CT scanner designed for upper extremity imaging, enabling the company to enter the U.S. market.

The Christchurch, New Zealand-based company said its MARS Bioimaging Extremity Scanner System is intended for use in community and point-of-care settings, including clinics, sports medicine practices and ambulatory units. The system produces high-resolution 3D X-ray images with the ability to distinguish between materials such as soft tissue, bone, blood vessels and metal implants.

According to the company, the scanner is designed to support multiple stages of care, including pre- and post-surgical planning, monitoring fracture healing and evaluating implant-related complications.
The system uses photon-counting detector technology originally developed through research at the European Laboratory for Particle Physics (CERN). MARS Bioimaging holds a license to commercialize the Medipix3 technology for medical imaging applications.

“It is very rewarding to see a technology developed initially for High Energy Physics transferred to the medical field for the benefit of society," said Rafael Ballabriga, spokesperson for the Medipix3 collaboration at CERN. "It was a long journey starting with the adaptation of the technology to spectroscopic X-ray imaging by the Medipix3 Collaboration. MARS then built a groundbreaking medical product around the device and overcame the many hurdles associated with achieving this major milestone of FDA approval. We congratulate them!”

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