FDA Clears AI-Powered Triage Platform for Digital Breast Tomosynthesis

The Food and Drug Administration (FDA) has granted 510(k) clearance for the AI-enabled CogNet AI-MT+ platform, which is geared to efficient triage of digital breast tomosynthesis (DBT) exams.

In order to help address the ongoing challenges with imaging volume, MedCognetics, the developer of the CogNet AI-MT+ platform, said the software alerts radiologists to DBT scans that may warrant higher priority on the worklist.

“Delayed diagnoses cost lives. When radiologists are overwhelmed by volume, critical findings can slip through the cracks. Our mission has always been to build AI that performs reliably across diverse patient populations, while helping clinicians address workflow pressures that directly affect patient access, diagnostic timelines, and overall quality of care. That's equity in action, not just principle,” noted Debasish “Ron” Nag, the CEO of MedCognetics.

MedCognetics noted the CogNet AI-MT+ software builds upon the Cognet AI-MT breast cancer screening software, which was granted FDA clearance in October 2024.