MARS Bioimaging gains FDA clearance for portable photon-counting CT scanner
MARS Bioimaging, a medical device company headquartered in New Zealand, has received USA Food and Drug Administration 510(k) clearance for its portable photon-counting CT scanner for upper extremity imaging.
Designed for use in community and point-of-care settings, the MARS Bioimaging extremity scanner delivers high resolution 3D x-ray images that visualise soft tissue, bone, blood vessels and metallic implants with clear material differentiation.
Chair Chris Stoelhorst said: “With FDA clearance, we can now scale clinical adoption of our scanners in the United States, the world’s largest CT market. This milestone supports our mission to enhance health economics and equity by expanding access to premium photon-counting CT imaging in community-based settings.”
The scanner leverages advanced detector technology developed originally through particle physics research at the European Laboratory for Particle Physics (CERN). MARS Bioimaging says it holds the exclusive licence from CERN to commercialise this Medipix3 technology for medical imaging. Spokesperson for the Medipix3 collaboration at CERN Rafael Ballabriga commented: “It is very rewarding to see a technology developed initially for high energy physics transferred to the medical field for the benefit of society. 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.”
Picture: MARS Bioimaging’s Group CEO Dr Ojas Mahapatra (left) with chair Chris Stoelhorst.
Read this report on page 11 of the May 2026 issue of RAD Magazine.
