i2Contour

by MRIMath  · Based in United States → — Transforming Medicine With Trustworthy AI
Neurosurgery Oncology Radiology
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Regulatory Status Disclosed

Overview

i2Contour is a web-based, AI-powered software platform developed by MRIMath. It is specifically designed to enhance the efficiency and precision of glioblastoma (GBM) management. The tool provides semi-automatic labeling, visualization, and volumetric quantification of WHO grade 4 glioblastoma from standard MRI images, including FLAIR and T1 contrast sequences. It combines advanced AI algorithms with a user-friendly interface, allowing trained medical professionals to review, manually contour, and approve tumor segmentations. The platform aims to significantly reduce the time required for GBM labeling and volume measurement, potentially saving physicians up to an hour per imaging study. By minimizing inter-user variability and improving precision, i2Contour supports better clinical decision-making, treatment planning, and monitoring of patient outcomes over time. The device operates as a secure cyber device, compliant with US FDA security measures, and offers collaborative team spaces to optimize workflow across various institutions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered GBM segmentation (FLAIR and T1 contrast sequences)
  • Smart manual contouring to reduce inter-user variability
  • Precise volume measurement and plotting for monitoring and treatment planning
  • Time-saving efficiency (reduces labeling/measurement time by up to an hour)
  • Secure cyber device compliant with FDA security measures
  • Collaborative team spaces for workflow optimization
  • DICOM viewer
  • Web-based software platform
  • Anonymization of patient data
  • Sharing and exchange capabilities

Use Cases

  • Glioblastoma (GBM) management
  • Brain tumor segmentation and volumetric analysis
  • Radiation therapy planning
  • Monitoring treatment response over time for GBM
  • Aiding clinical decision-making in neuro-oncology
  • Collaborative review and approval processes for imaging studies

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing — N/A
DeploymentCloud-based, web-based platform
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

FDA 510(k) clearance (K233822) was granted on August 8, 2024, for the MRIMath i2Contour cyber device and AI solution for glioblastoma (GBM) management. It is classified as a Medical Image Management and Processing System (21 CFR 892.2050).
Integrations
EHR Not specified
Specialties Neurosurgery, Oncology, Radiology

What the Web Says

i2Contour by MRIMath is an FDA-cleared AI-powered cyber device designed to enhance the efficiency and accuracy of glioblastoma (GBM) management. Physicians praise its ability to streamline contouring workflows, reduce variability, and provide precise volumetric analysis of brain tumors, ultimately aiming to improve patient outcomes and potentially lower healthcare costs.

Overall: Positive

Strengths

  • Significantly reduces GBM labeling and volume measurement time, potentially saving physicians up to an hour per imaging study.
  • Enhances accuracy with AI models yielding excellent labeling accuracy (95% for T1c and 92% for FLAIR) and precise volume measurements.
  • Minimizes inter-user variability in contouring due to smart manual contouring features.
  • User-friendly interface and easy integration into existing workflows.
  • Offers a secure, HIPAA-compliant cloud environment for remote work and collaboration.
  • Supports collaborative team spaces, optimizing workflow within and across institutions.

Limitations

No significant limitations found in public reviews. Consider checking vendor documentation or requesting a demo for a thorough evaluation.

Based on reviews from: Mrimath: Home, US FDA clears MRIMath i2Contour and AI solution for GBM management, FDA approved Secure Cyber Device and AI Solution for GBM - Sourcehere, MRIMath LLC, a Medical AI Company, Announces FDA 510(k) Clearance for its Cyber Device and AI Solution for Glioblastoma, MRIMath LLC, a Medical AI Company, Announces FDA 510(k) Clearance for its Cyber Device and AI Solution for Glioblastoma - Business Wire, FDA OKs MRIMath's Cyber Device and AI Solution for Glioblastoma

Last updated: 2026-07-21

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Press & Coverage

Business Wire
MRIMath LLC, a Medical AI Company, Announces FDA 510(k) Clearance for its Cyber Device and AI Solution for Glioblastoma
MRIMath LLC received FDA 510(k) clearance for its i2Contour cyber device and AI solution for glioblastoma management, which aims to improve efficiency and accuracy in tumor segmentation and reduce physician workload.
2024-08
Medical Device Network
US FDA clears MRIMath i2Contour and AI solution for GBM management
MRIMath's i2Contour, an AI-driven cyber device, has received FDA 510(k) clearance to enhance the efficiency and precision of glioblastoma management, potentially saving physicians up to an hour per imaging study.
2024-08
Medical Product Outsourcing
FDA OKs MRIMath's Cyber Device and AI Solution for Glioblastoma
The FDA has cleared MRIMath's i2Contour cyber device and AI solution for glioblastoma, which is designed to streamline segmentation and reduce contouring bottlenecks, saving physicians significant time.
2024-08
National Cancer Institute (NCI)
NCI Funding Helps Bring New AI-Aided Device for Glioblastoma to Market
With support from NCI's SBIR program, MRIMath's i2Contour cyber device, an AI-aided tool for measuring and labeling glioblastoma, received FDA clearance to assist physicians in accurate tumor segmentation and volumetric analysis.
2024-09
PMC (PubMed Central)
Robust AI-Driven Segmentation of Glioblastoma T1c and FLAIR MRI Series and the Low Variability of the MRIMathu00a9 Smart Manual Contouring Platform
This peer-reviewed study evaluates MRIMath's AI models for glioblastoma T1c and FLAIR MRI images, demonstrating high accuracy and low inter-radiologist variability when compared to manual contouring.
2024-05
Healio
FDA clears cyber device, AI system to address glioblastoma
MRIMath LLC's i2Contour cyber device and AI system have received FDA 510(k) clearance to improve the efficiency and accuracy of glioblastoma care by providing AI-powered tools that save physicians time.
2024-08
Rowan University
Rowan-based startup receives FDA clearance for medical technology
MRIMath, LLC, co-founded by a Rowan University professor, received FDA clearance for its i2Contour cyber tool, an AI-powered medical innovation designed to speed the mapping and measurement of glioblastoma brain tumors.
2024-11
MRIMath
MRIMath Achieves ISO 13485 Certification
MRIMath announced that it has achieved ISO 13485:2016 certification, an internationally recognized quality management standard for medical devices.
2026-03

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Frequently Asked Questions

i2Contour is a web-based software platform that provides AI-generated initial tumor contours for glioblastoma (GBM) on MRI FLAIR and T1 contrast sequences. Physicians can then review, manually adjust, and approve these contours, streamlining the process and potentially saving up to an hour per imaging study.
i2Contour is designed for the contouring and segmentation of T1 contrast (T1c) and FLAIR sequences of MRIs from patients already diagnosed with WHO grade 4 glioblastoma. Its AI models achieved high labeling accuracy, with 95% for T1c and 92% for FLAIR, aligning with radiologists' scores in FDA testing.
Yes, MRIMath i2Contour and its AI solution have received US FDA 510(k) clearance as a cyber device. It complies with FDA security measures, ensuring safe medical data management.
As a secure cyber device, i2Contour is compliant with US FDA security measures for safe medical data management. This ensures that patient medical data is handled securely and in accordance with regulatory standards.
i2Contour differentiates itself by offering AI-powered tools that significantly reduce GBM labeling and volume measurement times, addressing critical bottlenecks in patient care. It also minimizes inter-user variability in contouring, providing more consistent and precise results compared to purely manual methods.
While specific pricing details are not publicly available in the search results, i2Contour is highlighted for its potential to lower healthcare costs by improving efficiency and precision in GBM management. It can save physicians up to an hour per imaging study, which translates to significant time and resource savings for a practice.
i2Contour is specifically designed for semi-automatic labeling, visualization, and volumetric quantification of WHO grade 4 glioblastoma and is not intended for tumor detection or primary diagnostic purposes. It also does not alter original MRI images and is not for use with other brain tumor types.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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