---
AI Summary: "\\- Reimplemented the Local Gyrification Index algorithm in modern C++\
  \ with full parallelization.  \n- Built a complete web application using Django\
  \ and React for DICOM upload, processing, and reporting.  \n- Executed a 50+ case\
  \ clinical validation study with board‑certified radiologists.  \n- Prepared and\
  \ submitted an FDA 510(k) package, achieving clearance in July2025."
Anonymous: false
Assignee:
- ''
Last Edited Time: '2026-05-09T20:24:00+00:00'
case_study_510ks:
- 359bd5b7-a754-8129-a413-cfbb9ce54a0f
client_logo:
- 18dbd5b7-a754-80ea-8d26-e5ed3616fb74
client_name: NeuroSpectrum Insights, Inc
date: '2024-11-27'
featured: true
medical_panel: Neurology
name: 'Competitor: 5 years, $500k, no results. Us: 18 months, FDA cleared, IPO filed.'
services:
- 9dc4f55a-b5cb-419f-8bae-5e11d6b11fee
- 30311ab9-66a7-48a7-9dff-2927e1468480
- 11abd5b7-a754-8058-b035-f358222cec8c
summary: Full-cycle development of GyriCalc, a first-of-its-kind pediatric neuroimaging
  diagnostic. FDA cleared (K250686) July 2025. Filed for IPO in June 2025.
tags:
- Web-App
- 510k
- Image Processing
testimonials:
- 08b01619-db29-4a67-9948-6b6fbe9a2920
---

## The Problem

Autism affects 1 in 36 children, yet the average age of diagnosis is 4-5 years old---missing the critical early intervention window. Current diagnostic methods rely on behavioral observation, which is subjective, requires specialist access, and often leads to years of uncertainty for families.

NeuroSpectrum Insights had a vision: use MRI-based brain biomarkers to enable earlier, objective diagnosis in children as young as 2 years old.

## The Challenge

After spending **over \$500,000 on consultants across five years**, NeuroSpectrum had regulatory strategy documents but no working product. When they came to Innolitics, they needed:

- A complete software device built from research concepts
- A clinical validation study executed
- An FDA 510(k) submission prepared and submitted

Midway through development, the FDA rejected their planned approach of using FreeSurfer (established neuroimaging software) as a predicate---forcing a complete technical pivot.

## What We Did

Instead of treating this as a setback, we rebuilt the core algorithm from scratch:

- **Reimplemented the Local Gyrification Index algorithm** in modern C++ with full parallelization
- **Built a complete web application** (Django/React) for DICOM upload, processing, and clinical reporting
- **Executed a 50+ case validation study** with US-based board-certified radiologists
- **Prepared comprehensive regulatory documentation** including DHF and 510(k) package

GyriCalc labels 14+ functional brain regions and measures cortical folding patterns, providing clinicians with objective biomarkers where previously only subjective observation existed.

## Highlights  

<figure>
  <img src="/img/portfolio/Competitor_5_years_500k_no_results._Us_18_months_FDA_cleared_IPO_filed.-14abd5b7a75480ba8d2dede3ea0e50eb.png">
  <figcaption>
    Fig.1: Automatic segmentation of sub-cortical functional regions of the
    infant brain.
  </figcaption>
</figure>

<figure>
  <img src="/img/portfolio/Competitor_5_years_500k_no_results._Us_18_months_FDA_cleared_IPO_filed.-14abd5b7a75480a6b545e341fe051bd2.png">
  <figcaption>
    Fig.2: (Left) Outer surface or envelope of the pial surface. (Right)
    Cortical pial surface.
  </figcaption>
</figure>

<figure>
  <img src="/img/portfolio/Competitor_5_years_500k_no_results._Us_18_months_FDA_cleared_IPO_filed.-14abd5b7a75480a48a2fff18ce24d762.png">
  <figcaption>
    Fig.3: (Left) In red, vertex chosen to compute the local gyrification
    index in the outer surface. In yellow, the intersection of the outer
    surface with a sphere of a fixed radius. <br />
    (Right) The pial surface. In red, the projected perimeter from the outer
    surface.
  </figcaption>
</figure>

<figure>
  <img src="/img/portfolio/Competitor_5_years_500k_no_results._Us_18_months_FDA_cleared_IPO_filed.-14abd5b7a75480e79470ce48e171192e.png">
  <figcaption>
    Fig.4: (Left) The surface in the pial surface associated to the chosen
    (red point) vertex. (Right) The surface associated to the chosen vertex
    after intersecting it with a sphere of selected radius.<br />
    The local gyrification index (LGI) associated to the chosen vertex is
    the area of the cortex (left) divided by the area of the outer surface
    (right).
  </figcaption>
</figure>

<figure>
  <img src="/img/portfolio/Competitor_5_years_500k_no_results._Us_18_months_FDA_cleared_IPO_filed.-14abd5b7a7548028ad22e26e015bd0b8.png">
  <figcaption>
    Fig.5: (Left): Local Gyrification Index (LGI) computed in the outer
    surface every 10 vertices. (Right): Final LGI values in the cortical
    pial surface after projection.
  </figcaption>
</figure>

## The Result

**FDA 510(k) cleared July 2025 (K250686)** --- just 4.5 months after submission.

NeuroSpectrum Insights went from five years of false starts to FDA clearance in **under 18 months** with Innolitics. One month before clearance, they **filed for IPO** (June 2025).

GyriCalc is now the first FDA-cleared device of its kind: enabling objective measurement of brain structure in children as young as 2 years old to support early detection of neurodevelopmental conditions.