News and analysis on medical technology
FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears MARS Bioimaging's Portable Photon-Counting CT for Upper-Limb Imaging

The New Zealand company's compact scanner uses Medipix3 detector technology licensed from CERN and is designed for clinics and other community settings.

By News DeskMarch 24, 20262 min read
A woman inserts her arm into the round opening of a white MARS scanner
A person places an arm in the MARS Bioimaging Extremity Scanner, a compact spectral CT system for upper-extremity imaging. Photo: MARS Bioimaging · Company press image published with the FDA clearance release
FDA cleared510(k) · K252249FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared MARS Bioimaging's Extremity CT Imaging System under 510(k) K252249 on March 13, 2026, for CT imaging of the upper extremities of adults.
  • The scanner counts individual X-ray photons and measures their energy, using detector technology the company licenses from CERN.
  • The 510(k) summary names Carestream's OnSight 3D Extremity System as the predicate and Siemens' NAEOTOM Alpha photon-counting CT as a reference device.

MARS Bioimaging, a medical imaging company based in Christchurch, New Zealand, has received US Food and Drug Administration 510(k) clearance for a portable photon-counting CT scanner for imaging the arms, hands and wrists, the company announced on March 24.

The company said the MARS Bioimaging Extremity Scanner System is designed for community and point-of-care settings such as clinical offices, sports medicine clinics and ambulatory service units, Diagnostic Imaging reported.

What the FDA record shows

The FDA's 510(k) database lists the clearance as K252249 for the Extremity CT Imaging System from Mars Bioimaging Ltd. The agency received the traditional 510(k) on July 18, 2025, and found the device substantially equivalent on March 13, 2026. It is classed as a computed tomography X-ray system and was reviewed by the radiology panel.

According to the 510(k) summary, the system "is intended for x-ray computed tomography imaging of upper extremities of adult patients." It acquires volumetric spectral CT images using helical rotation of a single X-ray source and photon-counting detectors while the limb stays still. The scanner has a 12 cm entry port, which the summary describes as suited to imaging the hand and wrist, and is mobile but must be used in a stationary position.

Conventional CT scanners typically use energy-integrating detectors. The summary says the photon-counting Medipix detector instead detects individual X-ray photons and measures their energy, capturing more detailed information about the composition of the tissue being imaged. Images are post-processed in the company's MARS Vision software and sent to a hospital's picture archiving system.

The predicate is Carestream Health's OnSight 3D Extremity System, cleared as K160723, with Siemens' NAEOTOM Alpha photon-counting CT, K233657, as a reference device. The summary notes that the predicate is cleared for both upper and lower extremities in patients 12 and over, while the MARS device is cleared for upper extremities in adults.

CERN technology and US plans

MARS said its detectors use Medipix3 technology developed at CERN, the European particle physics laboratory, and that it holds the exclusive licence from CERN to commercialize the technology for medical imaging.

"With FDA clearance, we can now scale clinical adoption of our scanners in the United States, the world's largest CT market," said Chris Stoelhorst, chairman of MARS Bioimaging.

Mark Figgitt, the group chief operating officer who led the FDA process, said the scanner is designed for use "including pre- and post-surgical planning, assessment of fracture healing, and identification of implant-related complications." The company also named New York's Hospital for Special Surgery as a collaborator on the upper-extremity scanner.

MARS did not disclose pricing or a US launch date in its announcement.

Sources

  1. MARS Bioimaging gains FDA clearance for portable photon-counting CT scanner, MARS Bioimaging, March 24, 2026
  2. Portable Photon-Counting CT Device Gets FDA Nod for Upper Extremity Imaging, Diagnostic Imaging, March 24, 2026
  3. 510(k) K252249: Extremity CT Imaging System (database record), US Food and Drug Administration, March 13, 2026
  4. K252249 510(k) summary, US Food and Drug Administration, March 13, 2026