NSI (Automated Neuroanatomy in Infant brains)

NeuroSpectrum Insights, Inc

FeaturedSoftware DevelopmentGuided 510(k)Regulatory StrategyWeb-App510kImage Processing

Testimonial

After spending over $500,000 on other consultants over 5 years who knew how to sell but lacked expertise in execution, I'm delighted to have found Innolitics. Their combination of software engineering expertise, medical device experience, and scientific acumen helped me craft a regulatory strategy and FDA presubmission meeting that allowed me to secure investment and fund additional software development, which they have executed well. I have seen many engineers in my career at J&J and Ethicon and I can say with confidence that Innolitics are many standard deviations ahead of the curve.
Andrew Stewart

Andrew Stewart

CEO Neuro Spectrum Insights

The Problem

The detection of neurological and neurodevelopmental conditions in children is currently an observational exercise subject to biases and uncertainty.

Highlights

  • Our engagement with NeuroSpectrum Insights progressed from the concept of a challenging research problem to a fully engineered web application and a 510(k) submission
  • Gyricalc is able to label functional sub-regions (see Fig. 1) of the brain and objectively measure the cortex structure. It accomplishes this by calculating the local gyrification index, the degree of cortical folding in localized regions of the brain. (see Fig.5)
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.

What We Did

Report showing Local Gyrification Indices on the left hemisphere of the cortex.
  • Implemented a fully parallel Local Gyrification Index algorithm from scratch using modern C++.
  • Validated the product in infant brains starting at 2 years of age.
  • Created a web-app with Django in the backend and React in the frontend for the user to upload DICOM images, run the algorithm, track results, and interact with the report.
  • Ensured compliance with regulatory requirements, including comprehensive documentation and risk management
    Report showing the automatic segmentation of a cortical sub-region generated by Gyricalc.

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