Extremity-focused system is designed for point-of-care use, including clinics and ambulatory settings
MARS Bioimaging has received US Food and Drug Administration 510(k) clearance for its portable photon-counting CT scanner for upper extremity imaging.
The MARS Bioimaging Extremity Scanner System is intended for use in community and point-of-care settings. It produces 3D X-ray images designed to visualize soft tissue, bone, blood vessels, and metallic implants, with material differentiation.
Chris Stoelhorst, chairman of MARS Bioimaging, says the clearance enables the company to begin expanding use of the system in the United States.
“With FDA clearance, we can now scale clinical adoption of our scanners in the United States, the world’s largest CT market,” Stoelhorst says in a release. “This milestone supports our mission to enhance health economics and equity by expanding access to photon-counting CT imaging in community-based settings.”
Mark Figgitt, group COO of MARS Bioimaging, says the system is designed for use across the diagnostic pathway, including pre- and post-surgical planning, fracture-healing assessment, and identification of implant-related complications.
“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,” Figgitt says in a release.
The scanner uses photon-counting detector technology developed through research at CERN. MARS Bioimaging holds an exclusive license to commercialize the Medipix3 technology for medical imaging applications.
Rafael Ballabriga, spokesperson for the Medipix3 collaboration at CERN, says the development reflects the translation of physics research into clinical use. “It is very rewarding to see a technology developed initially for High Energy Physics transferred to the medical field for the benefit of society,” Ballabriga said.
Hospital for Special Surgery in New York City, a collaborator on the project, also acknowledged the clearance.
“We are excited to see MARS achieve this important milestone,” says Vijay Nair, managing director of business development at Hospital for Special Surgery, in a release. “Our collaboration with MARS on the portable photon-counting CT scanner for upper extremities has allowed us to support the development of imaging technology aimed at enhancing diagnostic patient care.”
MARS Bioimaging said the clearance supports its plans for US commercialization and may inform regulatory pathways in other markets.
Photo caption: MARS Bioimaging Extremity Scanner System, a portable photon-counting CT system for upper extremity imaging
Photo credit: MARS Bioimaging
