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New Zealand-headquartered medical device company Mars Bioimaging has gained United States Food and Drug Administration clearance for its portable photon-counting CT scanner for upper extremity imaging.
Designed for use in community and point-of-care settings, the ‘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.
Mars Bioimaging chair Chris Stoelhorst said the FDA clearance allowed the company to scale clinical adoption of its scanners in the US market, which is the world’s largest.
“This milestone supports our mission to enhance health economics and equity by expanding access to premium photon-counting CT imaging in community-based settings.”
Mars CEO Ojas Mahapatra also said the clearance “provides important validation that supports regulatory pathways and market adoption globally”.
Mars closed a $15 million Series A round in January this year.
