MARS Bioimaging gains FDA clearance for portable photon-counting CT scanner

MARS Bioimaging, a New Zealand–headquartered medical device company, has received U.S. Food and Drug Administration (FDA) 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 System delivers premium, high-resolution 3D X-ray images that visualise soft tissue, bone, blood vessels and metallic implants with clear material differentiation.

Chris Stoelhorst, Chairman of MARS Bioimaging, 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.”
 
Mark Figgitt, Group COO of MARS Bioimaging, who led the FDA process, added: “Achieving FDA clearance validates the safety and effectiveness of our portable photon-counting CT scanner, purpose-built for community-based settings, including clinical offices, sports medicine clinics and ambulatory service units. It is designed for clinicians to use across the diagnostic pathway, including pre- and post-surgical planning, assessment of fracture healing, and identification of implant-related complications.”

The scanner leverages advanced photon-counting detector technology developed originally through particle physics research at the European Laboratory for Particle Physics (CERN), home of the Higgs boson discovery. MARS Bioimaging holds the exclusive licence from CERN to commercialize this Medipix3 technology for medical imaging.
 
Rafael Ballabriga, Spokesperson for the Medipix3 collaboration at CERN, said: “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 ground-breaking medical product around the device and overcame the many hurdles associated with achieving this major milestone of FDA approval. We congratulate them!”

Hospital for Special Surgery (HSS) in New York City, the world's leading academic medical center focused on musculoskeletal health and a MARS Bioimaging collaborator, welcomed the FDA clearance news.

HSS Managing Director, Business Development, Vijay Nair said: “We are excited to see MARS achieve this important milestone. At HSS, our physicians and innovators are committed to continuously improving patient outcomes through our work with new technologies. Our collaboration with MARS on the portable photon-counting CT scanner for upper extremities is evidence of this and has allowed us to support the development of imaging technology aimed at enhancing diagnostic patient care.”

Dr Roland Toder, Partner at Pacific Channel, said: “Pacific Channel is proud to have backed MARS Bioimaging through its Series A and to have supported the company at board level through pivotal inflection points on its commercialisation pathway. FDA clearance is a defining milestone, providing independent validation of the technology and establishing a clear route into the U.S. clinical and reimbursement ecosystem. Our role extends well beyond capital. Through rigorous diligence and active board engagement, we work with companies to sharpen execution, align regulatory and reimbursement strategy, and position for global scale. MARS has delivered on each of these dimensions.”

Dr Ojas Mahapatra, Group CEO, MARS Bioimaging, said: “FDA clearance represents a pivotal milestone for MARS Bioimaging. In addition to enabling commercial rollout in the United States, it provides important validation that supports regulatory pathways and market adoption globally.”