Neurology · De Novo · 2024
BrainSee
Darmiyan, Inc.. Granted by FDA on 11 January 2024 under submission DEN220066, product code QWT (prognostic assessment software of mild cognitive impairment). What FDA's record says, in FDA's words.
Device record · DEN220066
- Device. BrainSeeDEVICE
- Company. Darmiyan, Inc.COMPANY
- Decision. 11 January 2024, De NovoDECISION
- Panel. NeurologyPANEL
- Product code. QWT, Prognostic Assessment Software Of Mild Cognitive ImpairmentCODE
- Regulation. 21 CFR 882.1454, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
The BrainSee is indicated as follows: "BrainSee is a software application indicated as a prognostic tool to aid in the clinical assessment of how likely patients aged between 55 and 95 years old who are diagnosed with amnestic mild cognitive impairment (aMCI) are to progress to clinical Alzheimer's disease (AD)-dementia within 5 years of assessment. BrainSee analyzes inputs of brain magnetic resonance imaging (MRI), patient demographic information, and cognitive assessment scores to produce a similarity score between 0 and 100 reflecting the degree of similarity between the patient and two reference populations of aMCI patients who either did not progress to clinical AD-dementia within 5 years (non-converters) or progressed to clinical AD-dementia within 5 years (converters). Clinical AD-dementia is defined as probable Alzheimer's disease established according to the National Institute of Neurological and Communicative Disorders and Stroke — Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer's Criteria. • Similarity scores less than 50 indicate that a patient's inputs are more similar to those of the non-converter population. • Similarity scores greater than 50 indicate that a patient's inputs are more similar to those of the converter population. • Patients with a similarity score close to 50 have inputs that are similar to both the converter and non-converter aMCI patient populations used to develop and train the BrainSee device. The similarity […]
The product code's definition, from FDA's classification record. 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 Alzheimers 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedMRI
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QWT. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QWT, in Neurology, or granted in 2024. The whole record is at FDA AI-enabled medical devices.
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