BrainSee

DEN220066

Darmiyan, Inc. · granted 2024-01-11 · product code QWT · Neurology

FDA De Novo summary for BrainSee (DEN220066)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
0
Performance observations
4
Product code
QWT
FDA De Novo source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.2)
“BrainSee is a software as a medical device (SaMD) intended to aid clinicians in evaluating the prognosis of patients diagnosed with amnestic mild cognitive impairment (aMCI).”
AlgorithmThe device calculates a similarity score using cognitive/behavioral test scores (Mini-Mental State Examination (MMSE) and Clinical Dementia Rating Sum of Boxes (CDRSumBox)), patient age and sex, and brain tissue volumes measured from T1-weighted brain MRI. The underlying model collects and analyzes this data to produce the final device outputs.
source quote (p.3)
“To calculate the similarity score, BrainSee uses: 1. Cognitive/behavioral test scores, including scores from the Mini-Mental State Examination (MMSE) and Clinical Dementia Rating Sum of Boxes (CDRSumBox) provided by the clinician. 2. The patient's age and sex. 3. Brain tissue volumes measured from T1-weighted brain MRI. The device algorithm was provided describing how the data are collected and analyzed by the underlying model that is applied to produce the final device outputs.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.3)
“A hazard analysis characterized the software and cybersecurity risks, including those related to device malfunction, user-related error, and network connectivity.”

Validation studies (1)

Retrospective clinical

n=198 patients · 27 site(s)

endpoints: Sensitivity > 70% based on pre-defined classification threshold.; Specificity > 70% based on pre-defined classification threshold.

Reported performance (4 observations)

sensitivity72.9CI 64.9% to 80.9%
source quote (p.7)
“Sensitivity (SN) 72.9% 64.9% to 80.9%”
specificity96.3CI 92.1% to 100%
source quote (p.7)
“Specificity (SP) 96.3% 92.1% to 100%”
ppvas written: “Positive predictive value (PPV)”96.6CI 92.9% to 100%
source quote (p.7)
“Positive predictive value (PPV) 96.6% 92.9% to 100%”
npvas written: “Negative predictive value (NPV)”70.6CI 62.1% to 79.2%
source quote (p.7)
“Negative predictive value (NPV) 70.6% 62.1% to 79.2%”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-08-26.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to De Novo AI/ML devices in the Neurology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/DEN220066