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Calidar has closed out its first-in-human study of the Eidos Prism, a device that adds Volumetric X-Ray Diffraction, marketed as 4D Mammography, to existing 3D mammography systems. The study enrolled 61 patients at Baptist Health Hardin in Elizabethtown, Kentucky. Two manuscripts covering the device's performance and an accompanying reader study have gone out for peer review, with publication expected later this year.
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The company is now selecting sites for a pivotal study planned for 2027, targeting five to seven locations across the Northeast, Southeast, Southwest, and Northwest, deliberately mixing rural and community health systems with academic medical centers and independent imaging centers. That spread suggests Calidar wants performance data across varied patient populations and equipment setups before pursuing regulatory clearance, rather than relying on results from a single type of institution.
VP of Clinical Thomas Blum described the goal as building partnerships centered on "providing clearer information to patients earlier in the diagnostic process."
Add-on devices that upgrade existing imaging infrastructure, rather than requiring hospitals to buy entirely new systems, have been a consistent theme in breast imaging investment, since they lower the adoption barrier for health systems already running 3D mammography. Calidar's approach to sequencing, a single-site FIH study followed by a deliberately diverse multi-site pivotal, mirrors a path other diagnostic imaging companies have used to build the breadth of evidence FDA reviewers expect before clearance.
