Devices · Darmiyan, Inc.

BrainSee

Darmiyan, Inc. is listed for BrainSee (DEN220066). The FDA list gives January 11, 2024 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QWT as “Prognostic Assessment Software Of Mild Cognitive Impairment”: Prognostic assessment software of mild cognitive impairment. Prognostic assessment software of mild cognitive impairment is a prescription-only device that combines information from multiple clinical data sources to produce an output indicative of the likelihood that a patient diagnosed with mild cognitive impairment will progress to more severe forms of cognitive impairment, or will develop dementia, such as Alzheimer’s disease dementia, within a specified period of time. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic too. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220066

Official FDA database record

Date of final decision

January 11, 2024

Company on the FDA list

Darmiyan, Inc.

Lead panel

Neurology

Primary product code

QWT

openFDA device name for the code

Prognostic Assessment Software Of Mild Cognitive Impairment

Device class

2

Regulation number

882.1454

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned