4D mammo may be up to four times more accurate than 3D
A new 4D mammography technique could diagnose cancer with up to four times the precision of 3D digital breast tomosynthesis (DBT) exams.
That’s according to early data out of an ongoing first-in-human clinical trial at Baptist Health Hardin in Elizabethtown, Kentucky. The trial is testing the utility of the 4D mammography system developed by Calidar Inc.—a medical technology startup out of North Carolina. Calidar’s 4D system harnesses X-ray diffraction imaging to measure molecular-level signatures of disease; these tissue “fingerprints” could help providers diagnose breast cancer in its earliest stages, but current mammography systems do not have this capability.
Calidar has indicated that its 4D system also allows for exams to be completed more quickly, and at a reduced radiation dose compared to 2D and 3D scans.
So far, the trial has enrolled 61 participants who have undergone imaging. Now, experts are transitioning to the data analysis phase, and early results so far indicate that the technology could represent a significant improvement over current breast imaging methods, according to Joshua Carpenter, PhD, who serves as the chief technology officer of Calidar.
"First-in-human is the gate that separates promise from evidence," Carpenter said in a release. "We cleared it — and the early performance data is directionally aligned with our clinical thesis, with early signals pointing to up to 4x improvement in precision over 3D mammography. Full analysis is ongoing, but we now have human evidence that suggests 4D Mammography works. Everything that follows is about scale."
While researchers are working toward completing a full analysis of the exams, leaders at Calidar are initiating a Series A raise that will fund a multi-site pivotal study in the U.S. The company expects to publish a peer-reviewed paper on the data later in 2026 and plans to submit the multi-site findings to the U.S. Food and Drug Administration for clearance consideration.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.