MedCognetics Receives FDA 510(k) Clearance for CogNet AI-MT+ Radiological Computer-Aided Triage and Notification Software
Dallas, Texas–(Newsfile Corp. – 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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About CogNet AI-MT®
CogNet AI-MT is part of MedCognetics’ comprehensive CogNet AI platform, designed to enhance radiologists’ capabilities by expanding insights and awareness in medical imaging. This unbiased platform, trained on a diverse global dataset, advances the performance of radiologists and imaging centers, delivering accurate care for patients worldwide. CogNet AI-MT employs advanced AI and Machine Learning (ML) to detect early signs of cancer across all ethnicities. The platform is FDA 510(k) cleared for triage of mammogram images.
About MedCognetics, Inc.
MedCognetics provides an advanced AI software platform that integrates into radiology workflow. In addition, the AI algorithm is trained on a diverse global patient dataset to mitigate data bias. The future of AI in healthcare is unbiased services and MedCognetics is at the forefront of creating a more predictable medical outcome and ultimately saving lives. Founded in 2020, the company is based in Dallas, Texas. For more information, please visit our website at www.medcognetics.com.
Contacts:
Alicia V. Nieva-Woodgate, ANW Networks
+1 720.808.0086
alicia@anwnetworks.com
Source: MedCognetics
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