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.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
