Portable Photon-Counting CT Device Gets FDA Nod for Upper Extremity Imaging

The Food and Drug Administration (FDA) has granted 510(k) clearance for the MARS Bioimaging Extremity Scanner System, which enables portable photon-counting computed tomography (PCCT) scans for upper extremity imaging.

Providing advanced photon-counting detector technology developed at the European Laboratory for Particle Physics, the MARS Bioimaging Extremity Scanner System offers high-resolution 3D visualization of blood vessels, bone, soft tissue and metallic implants, according to MARS Bioimaging, the manufacturer of the device.

Mark Figgitt, the chief operating officer for MARS Bioimaging, said the portability of the device facilitates access to the technology in a variety of clinical settings.

“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,” noted Figgitt.