Calidar has completed enrollment in its clinical study of the company's 4D mammography system, enrolling 61 patients at Baptist Health Hardin in Elizabethtown, KY.
The system uses x-ray diffraction to measure molecular-level signals within breast tissue. The study, which began in August 2025, will evaluate the system's ability to distinguish between healthy tissue and breast cancer. Data analysis will be ongoing and a peer-reviewed publication is anticipated in the second half of 2026, Calidar said. The company added that early signals suggest up to a fourfold improvement in precision over 3D mammography, though full analysis has not yet been completed.
Calidar said it is initiating a series A funding round to support a multisite pivotal study, following which the company anticipates submitting results to the U.S. Food and Drug Administration (FDA) in pursuit of clearance. The system is currently investigational and has not been cleared or approved by the FDA.
