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MedCognetics Receives FDA 510(k) Clearance for CogNet AI-MT+ Radiological Computer-Aided Triage and Notification Software
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FDA Clears MedCognetics' Enhanced AI Software for Prioritizing Suspicious Mammograms
The U.S. Food and Drug Administration has granted 510(k) clearance to MedCognetics for its CogNet AI-MT+ radiological computer-aided triage and notification software. This regulatory milestone permits the commercialization of the enhanced AI-enabled device in the United States under 21 CFR 892.2080, with the FDA determining it to be substantially equivalent to legally marketed predicate devices. CogNet AI-MT+ is designed to integrate into existi…
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