GyriCalc
Overview
GyriCalc, developed by NeuroSpectrum Insights, is an automated radiological image post-processing Software as a Medical Device (SaMD) designed to assist clinicians in evaluating pediatric brain structures. The tool is indicated for use with pediatric patients between 24 and 36 months of age.
The software processes magnetic resonance (MR) images to perform automated labeling, visualization, and quantification of segmentable brain structures. Key capabilities include:
- Automatic segmentation and labeling of over 14 functional brain regions.
- Volumetric, surface area, and cortical thickness measurements.
- Gyrification analysis, including calculation of the local gyrification index to measure cortical folding patterns.
- Generation of detailed, graphical morphometric reports and segmented images.
GyriCalc fits into clinical and diagnostic workflows by providing objective, quantitative brain biomarkers. It is designed to be operated by qualified technical personnel and interpreted by qualified clinicians, such as pediatric neurologists and radiologists, to support the early identification of structural markers associated with neurodevelopmental differences.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Automated analysis of MRI images
- Identifies early structural markers of neurodevelopmental differences
- Assists in the diagnosis of autism
- Labels 14+ functional brain regions
- Measures cortical folding patterns
- Provides objective biomarkers
- Supports early detection in children as young as 2 years old
- Average accuracy rate of 92% (range 88-97%) in analyzing structural MRIs
- Web application for DICOM upload, processing, and clinical reporting
Use Cases
- Diagnosis of autism
- Early detection of neurodevelopmental conditions
- Objective measurement of brain structure in young children
- Supporting diagnostic decision making and care planning
- Potential future diagnosis of dyslexia, ADHD, and schizophrenia
What Physicians Need to Know
GyriCalc offers an objective, MRI-based biomarker approach to complement traditional behavioral observations for early diagnosis of neurodevelopmental conditions, particularly autism, in young children. This can facilitate earlier intervention and precision care. The system provides analytical visuals to support clinical decision-making.
GyriCalc operates via a complete web application designed for DICOM upload, processing, and clinical reporting. This web-based platform allows for the submission of MRI data and the generation of analytical reports.
Details
| Category | Neurology AI, Radiology & Imaging AI |
| Pricing | Not disclosed publicly. the company has not generated revenues to date and has mentioned that reimbursement is a critical factor for market penetration. |
| Deployment | Web application |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated GyriCalc received FDA 510(k) clearance on July 22, 2025 (K250686), approximately 4.5 months after its submission in March 2025. It is the first FDA-cleared device of its kind for objective measurement of brain structure in children as young as 2 years old to support early detection of neurodevelopmental conditions. |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurology, Pediatrics, Radiology |
What the Web Says
GyriCalc is a proprietary, FDA-cleared software solution developed by NeuroSpectrum Insights. It is designed to assist physicians in diagnosing autism in children as young as 2 years old by identifying early structural markers of neurodevelopmental differences through automated analysis of MRI images. The software provides objective measurements of brain structure, including volume, area, and gyrification index, which can help address the limitations of subjective behavioral observation in current diagnostic methods.
Overall: MixedStrengths
- Enables earlier, objective diagnosis of neurodevelopmental conditions like autism in children as young as 2.
- Utilizes MRI-based brain biomarkers for diagnosis, offering an objective alternative to subjective behavioral observation.
- Provides automated labeling, visualization, volumetric quantification, surface area, thickness, and gyrification analysis of brain structures.
- Generates PDF reports with segmented color overlays and morphometric data for clinicians.
- FDA 510(k) cleared, indicating it meets regulatory standards for safety and effectiveness.
- Potential for expansion to diagnose other neurological conditions like dyslexia, ADHD, and schizophrenia.
Limitations
- NeuroSpectrum Insights has not generated any revenue yet.
- The company faced initial challenges and a technical pivot during development, including the FDA rejecting their planned approach using FreeSurfer as a predicate.
- No specific physician, healthcare IT, tech reviewer, Reddit, G2, or Capterra reviews for GyriCalc were found in the search results.
- The software does not currently support the Linux OS.
- The available information on the predicate device (NeuroQuant) does not specify the magnet strength it supports.
Based on reviews from: Innolitics, IPOScoop, PitchBook, accessdata.fda.gov
Last updated: 2026-07-21
Ratings & Reviews
No reviews yet. Be the first to review this tool!
Rate GyriCalc
Press & Coverage
Videos
Product demos, reviews, and walkthroughs for GyriCalc.
Empowering Clinicians With Early, Objective Brain Insights | Introducing GyriCalcu2122 from NSI
NeuroSpectrum Insights
