MedCognetics has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CogNet AI-MT+ software platform.
The software is designed to improve radiologists' capabilities by expanding insights and awareness in medical imaging with computer-aided triage and notification. The platform, trained on a diverse global dataset, employs advanced AI and machine learning to detect early signs of cancer across all ethnicities.
Built on the MedCognetics CogNet AI-MT platform, CogNet AI-MT+ integrates into existing imaging and IT systems to support worklist prioritization. The software analyzes digital breast tomosynthesis (DBT) exams and flags studies that may need prioritized review.
This latest clearance expands MedCognetics’ regulatory footprint in breast imaging AI, the company said. It previously received FDA 510(k) clearance for its earlier-generation AI-enabled breast cancer screening software.
![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)
