# Federal Register #2026-22590

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

**Buyer:** Department of Health and Human Services / Food and Drug Administration
**Posted:** November 05, 2026
**Identifier:** 2026-22590

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.

[View original listing](https://www.federalregister.gov/documents/2026/11/05/2026-22590/medical-devices-neurological-devices-classification-of-the-prognostic-assessment-software-of-mild)