Competitor: 5 years, $500k, no results. Us: 18 months, FDA cleared, IPO filed.

Full-cycle development of GyriCalc, a first-of-its-kind pediatric neuroimaging diagnostic. FDA cleared (K250686) July 2025. Filed for IPO in June 2025.

Andrew Stewart

After spending $500K over five years on consultants who knew how to sell but couldn't execute, Innolitics took us from concept to FDA clearance in under 18 months for a first-of-its-kind MRI neuroimaging device. When FDA questioned our original approach, they adapted without losing momentum. We submitted on schedule and cleared in 4.5 months. I've seen many engineers at J&J and Ethicon — Innolitics is many standard deviations ahead of the curve.

Andrew StewartCEO Neuro Spectrum Insights
ClientMedical areaNeurology FDA GyriCalc K250686 · cleared 2025 · AI/ML Software DevelopmentGuided 510(k)Web-App510kImage Processing

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

Fig.1: Automatic segmentation of sub-cortical functional regions of the infant brain.
Fig.2: (Left) Outer surface or envelope of the pial surface. (Right) Cortical pial surface.
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.
(Right) The pial surface. In red, the projected perimeter from the outer surface.
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.
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).
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.

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.

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