Contact

News

Announcements

The NSI team, our collaborators at Innolitics, and our partners at the University of Louisville are very pleased to announce that on July 22, 2025, the U.S. Federal Drug Administration (FDA), in compliance with the Medical Image Management And Processing System Regulation, issued NSI clearance to market our proprietary software, named GyriCalcTM.

Read the press release.

Timeline

July 2025
FDA Clearance

NSI receives FDA clearance to market GyriCalcTM, an automatic labeling, visualization, and quantification (including volume, surface area, and gyrification) analysis software system, for segmented brain structures as represented by structural MRI scans.

March 2025
510(k) Application

In collaboration with the software engineering leader Innolitics, NSI submits its 510(k) application for marketing clearance to the FDA.

January 2025
"Ground Truth" Validation

NSI in collaboration with the software engineering leader, Innolitics, completes its “ground truth” clinical validation study and readies results for FDA 501(k) submission of the GyriCalcTM software system.

October 2024
Unveiling

NSI unveils its recently developed company identity and branding suite.

June 2024
“Ground Truth” Evaluation

NSI, in collaboration with the software engineering leader Innolitics, launches a focused “ground truth” evaluation to prepare for its FDA clearance submission.

February 2023
Name Change

The investigational company Autism Diagnostic Technologies, Inc. changes its name to NeuroSpectrum Insights, Inc. (NSI) to more accurately reflect its comprehensive vision, mission, and commercialization objectives.

December 2022
Ramping Up

Following a seven-year exploration of a breakthrough technology for assessing neurological and neurodevelopmental disorders, Autism Diagnostic Technologies, Inc. begins ramping up for the commercialization of the technology.

May 2017
New Leadership

Andrew Stewart tapped as CEO of NeuroSpectrum Insights.

October 2016
Founding

Our technology licensed for commercial use. Read more about the technology.

NeuroSpectrum Insights, Inc.

We envision a world where clinicians have the ability to uncover neurologic and neurodevelopmental conditions as early as possible, paving the way for timelier interventions and better patient outcomes.

Facebook-f Linkedin

Helpful Links

Sign up for Latest Updates

© 2025 NeuroSpectrum Insights, Inc. All rights reserved. | web design