New Zealand-based Mars Bioimaging has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its portable photon-counting CT (PCCT) scanner for upper extremity imaging.
MARS Bioimaging Extremity Scanner System, a portable PCCT device for upper extremity imaging.MARS Bioimaging
The company's MARS Bioimaging Extremity Scanner system is for use in community and point-of-care settings, including clinical offices, sports medicine clinics, and ambulatory service units. It produces high-resolution 3D images that visualize soft tissue, bone, blood vessels, and metallic implants with material differentiation, the firm said. Intended applications include pre- and postsurgical planning, assessment of fracture healing, and identification of implant-related complications.
The scanner uses photon-counting detector technology based on Medipix3, originally developed through particle physics research at the European Organization for Nuclear Research (CERN). MARS Bioimaging holds an exclusive license from CERN to commercialize the technology for medical imaging, it noted.
