FDA Device Pathway · Pre-Submission Phase

Objective ASD Assessment
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Multi-Modal AI

TapVision AI is developing an FDA-regulated platform that integrates eye-tracking, EEG, and behavioral biomarkers to deliver objective, scalable autism spectrum disorder assessment — reducing diagnostic delays from years to minutes.

1 in 36
Children diagnosed with ASD in the U.S.
2–3 yrs
Average delay from first concern to diagnosis
Modalities integrated (gaze · EEG · behavior)
FDA
De Novo device pathway — pre-submission

Diagnosis is subjective,
slow, and inaccessible

Current gold-standard tools like the ADOS-2 require highly trained clinicians, 2–3 hour assessments, and months-long waitlists — leaving millions of families without answers during the most critical developmental window.

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Examiner Dependency

Gold-standard ADOS-2 requires specialized training and introduces significant inter-rater variability in scoring.

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Geographic Barriers

Specialist shortages mean rural and underserved communities wait 18–36 months for a first evaluation.

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No Objective Biomarker

No FDA-cleared biological or physiological measure exists for ASD diagnosis — assessment remains purely behavioral and subjective.

2–3yr

Average time from a parent's first developmental concern to a child receiving a formal ASD diagnosis in the United States — a gap that directly delays access to early intervention therapies proven to improve outcomes.

TARGET OUTCOME
From years to a single session
Scalable, objective, clinician-agnostic

Three signals.
One integrated score.

TapVision's platform acquires and fuses three complementary physiological and behavioral data streams — each independently validated as ASD-relevant — into a single, interpretable biomarker output.

01 / GAZE
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Oculomotor Biomarkers

Quantifies fixation patterns, social scene scanning, saccade dynamics, and orienting responses to social stimuli. Children with ASD exhibit characteristic gaze avoidance and atypical visual attention patterns detectable in milliseconds.

Fixation Duration Social ROI Dwell Saccade Amplitude Pupillometry
02 / EEG

Neural Signal Features

Extracts EEG-derived spectral and event-related potential features associated with ASD neural circuits — including frontal theta-band power, mu suppression, N170 face processing, and functional connectivity signatures.

Theta Band Power Mu Suppression N170 / P300 Functional Connectivity
03 / BEHAVIOR
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Behavioral Response Metrics

Captures motor timing, sensory processing latencies, adaptive response patterns, and social attention behaviors through structured tablet-based tasks designed to elicit and quantify ASD-relevant behavioral phenotypes.

Motor Timing Response Latency Sensory Processing Adaptive Behavior

From signal acquisition
to clinical insight

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Acquire
Tablet-based session captures gaze, EEG, and behavioral signals simultaneously
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Process
Real-time signal preprocessing — bandpass filtering, artifact rejection, fixation parsing
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Extract
Feature extraction across all three modalities — 100+ biomarker dimensions
⚙️
Fuse
Multi-modal ML fusion model integrates signals into unified biomarker score
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Report
Clinician-facing output with interpretable biomarker profile and confidence metrics

Built by a clinician.
Designed for clinicians.

MM
MohammedYusuf Modan, MD
Founder & Principal Investigator
Psychiatry, MD FDA Device SBIR Applicant ORCID Registered IRB PI
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Clinical Practice

Practicing physician with direct clinical expertise in autism spectrum disorder assessment — TapVision is built from firsthand understanding of diagnostic gaps and clinical workflow constraints.

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Research Infrastructure

Active SFARI Base researcher. SPARK cohort application submitted. SFARI Base account active. ORCID: 0009-0005-2788-3223. IRB protocol in preparation.

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Regulatory Pathway

TapVision AI LLC is a Delaware-registered company pursuing FDA De Novo device classification. SBIR Phase I application in preparation. Patents pending.

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Corporate Structure

TapVision AI LLC operates as an independent subsidiary within a multi-entity healthcare technology holding structure, maintaining separation between device development and clinical practice.

Interested in TapVision?

Whether you're a researcher, clinician, investor, or partner — we'd like to hear from you.

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