Company Profile
NeuroSpectrum Insights, Inc. is a USA-based developer of software-as-a-medical-device (SaMD) for neurodevelopmental diagnosis, headquartered in Bedminster, New Jersey, USA. Founded in 2016 as Autism Diagnostic Technologies, Inc., the company was renamed in 2024 and operates as an independent privately held entity, led by Chief Executive Officer Andrew Stewart. NeuroSpectrum Insights is pioneering objective, MRI-based brain biomarker analysis to facilitate early diagnosis of autism and other neurodevelopmental conditions.
Core Products ＆ Technologies
GyriCalc Neuroanatomy Analysis System
• GyriCalc (Version 1.0.0): FDA 510(k)-cleared (K250686, July 2025) automated software for labeling, visualization, and morphometric quantification of brain structures in children ages 24–36 months
• Local Gyrification Index (LGI): Proprietary algorithm measuring cortical folding patterns to identify early structural markers of neurodevelopmental differences
• 3D Brain Mapping: Automated segmentation of 14+ functional brain regions from 3D T1 MRI series with artifact correction and skull-stripping
• Clinical Report Output: PDF morphometric reports with color overlays for clinician review and diagnostic support
Software Architecture ＆ Pipeline
• Image Preprocessing: Motion correction, intensity normalization, bias field correction, and volumetric measurement modules
• Web-Based Platform: DICOM upload, cloud processing, and clinical reporting interface built on Django/React architecture
• Expansion Pipeline: Planned algorithm development for dyslexia, ADHD, and schizophrenia diagnosis in the latter half of 2026
Market Position ＆ Certifications
NeuroSpectrum Insights holds a pioneering position in the MRI-based neurodevelopmental diagnostics market, competing with EarliPoint Health (eye-tracking diagnostics) and conventional behavioral observation methods. Key strengths include:
• 10+ years of neuroimaging software development heritage through University of Louisville research partnership
• FDA 510(k) clearance: Class II device (Product Code: LLZ, Regulation 892.2050) cleared in July 2025
• Clinical validation: 50+ case validation study with US board-certified radiologists; 94% accuracy claim for autism identification
• Early detection focus: First FDA-cleared device enabling objective brain structure measurement in children as young as 2 years old
• Predicate strategy: Substantial equivalence established to NeuroQuant (K170981) for regulatory pathway
Corporate Timeline
2016 — Founded in Delaware as Autism Diagnostic Technologies, Inc.
2017 — Andrew Stewart appointed CEO to lead commercialization of neurodiagnostic technology
2024 — Renamed to NeuroSpectrum Insights, Inc.; continued development of GyriCalc platform
2025 — Filed FDA 510(k) premarket notification (March); received FDA clearance (July, K250686); filed S-1 for NYSE IPO (June)
2026 — Set IPO terms on May 5 for 3.75M shares at $4–$5 (NYSE: NSIH); preparing US and Canadian commercial launch of GyriCalc
Target Markets ＆ Applications
• Pediatric Neurology ＆ Autism Clinics: Objective MRI-based diagnostic support for children aged 24–36 months with suspected autism spectrum disorder
• Developmental Pediatrics: Early intervention facilitation by reducing diagnostic delay from average 4–5 years to toddler age
• Radiology ＆ Neuroradiology: Quantitative neuroanatomy reports for board-certified radiologists reviewing pediatric brain MRI
• Future Neurodevelopmental Indications: Planned expansion to dyslexia, ADHD, and schizophrenia algorithms for broader psychiatric and neurological markets
Contact Information
Global Headquarters
Address: 367 Main Street, Ste. 105, Bedminster, NJ 07921, USA
Telephone: +1 908-304-4858
Website: neurospectruminsights.com
Corporate Leadership
Chief Executive Officer: Andrew Stewart
Status: Privately held (pre-IPO; S-1 filed June 2025; terms set May 2026)
Planned Listing: NYSE (proposed symbol: NSIH)
