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.
