Dallas, Texas - February 5, 2026
MedCognetics, Inc., a company focusing on medical imaging AI, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for CogNet AI-MT+, its enhanced AI-enabled radiological computer-aided triage and notification software. The device is cleared under 21 CFR 892.2080 (Radiological Computer Aided Triage and Notification Software), Class II, Product Code QFM. The FDA determined the device to be substantially equivalent to legally marketed predicate devices, permitting commercialization in the United States.
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Key Takeaways:
- MedCognetics’ CogNet AI-MT+ has received FDA 510 (k) clearance for radiological computer-aided triage and notification, expanding its regulatory footprint in AI-driven breast imaging.
- CogNet AI-MT+ integrates into existing imaging systems to help radiologists manage increasing imaging volumes, flagging suspicious 3D mammography (DBT) exams for prioritized review.
- This reflects MedCognetics' mission to improve health equity through unbiased AI.
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Contacts:
Alicia V. Nieva-Woodgate, ANW Networks
+1 720.808.0086
[email protected]
Source: MedCognetics
Distributed by: Reportable, Inc.
