Federal Register #2026-22590

FDA Classifies Darmiyan BrainSee Prognostic Assessment Software as a Class II Medical Device

The FDA issued a regulatory classification for BrainSee, software intended to support prognostic assessment of mild cognitive impairment. - Government agency: U.S. Department of Health and Human Services, Food and Drug Administration (FDA). - OEM and requester: Darmiyan, Inc., developer of the BrainSee device and requester of its De Novo classification. - Product: BrainSee prognostic assessment software; no part number or purchase quantity is specified. - Uses multiple clinical data sources to estimate the likelihood that a person with mild cognitive impairment will progress to more severe impairment or dementia. - Intended for prescription use as an adjunct—not as a stand-alone diagnostic or prognostic tool. - Regulatory requirements: Class II device subject to special controls, including clinical performance validation, software verification and validation, hazard analysis, human-factors and usability assessment, and physician and patient labeling. Postmarket surveillance may be required. - Procurement status: This is a regulatory classification action, not a procurement opportunity; no products or services are being solicited.

Description

The Food and Drug Administration is classifying prognostic assessment software for mild cognitive impairment as a class II device subject to special controls. The prescription-only device combines multiple clinical data sources to estimate the likelihood that a patient with mild cognitive impairment will progress to more severe impairment or develop dementia within a specified period. It is intended for adjunctive use, not as a stand-alone diagnostic or prognostic tool. The final order codifies requirements for clinical performance testing, software verification and validation, usability assessment, and physician and patient labeling.

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