MRIMath LLC, a Medical AI Company, Announces FDA 510(k) Clearance for its Cyber Device and AI Solution for Glioblastoma

MRIMath LLC, an AI company funded by the National Cancer Institute, proudly announces that the U.S. Food & Drug Administration (FDA) has granted clearance to its groundbreaking cyber device, MRIMath i2Contour, and AI designed to enhance the efficiency and accuracy of glioblastoma (GBM) management. This innovative tool can save physicians up to an hour per imaging study, significantly reducing bottlenecks in contouring and accelerating patient care.

GBM is the most common and lethal primary brain tumor in adults, presenting substantial challenges in timely and accurate segmentation. The MRIMath i2Contour device provides advanced AI-powered and Smart tools that streamline the process, reducing inter-user variability and improving precision. By facilitating faster, more accurate reviews, this tool has the potential to improve patient outcomes and reduce healthcare costs. The device enables physicians to deliver optimal treatments across geographies and contribute to an overall better patient experience.

Key features of this device include:

1. Time-Saving Efficiency: Reduces GBM labeling and volume measurement time by up to an hour, addressing a critical bottleneck.
2. Secure Cyber Device: Compliant with FDA security measures for safe medical data management.
3. Collaborative Team Spaces: Optimizes workflow within and across institutions, rural and urban, enhancing access to healthcare and multidisciplinary coordination.
4. Accurate AI Labeling: Provides precise labeling of GBM magnetic resonance imaging (MRI) FLAIR and T1 contrast (T1c) sequences to support clinical decision-making.
5. Smart Manual Contouring: Lowers inter-user variability and facilitates easy review and approval processes.
6. Volume Measurement and Plotting: Offers essential tools for precise monitoring over time and treatment planning.
7. DICOM Viewer.

MRIMath AI models yielded an excellent labeling accuracy of 95% for T1c and 92% for FLAIR that align with radiologists’ scores in accuracy testing submitted to the FDA. The MRIMath Smart manual contouring platform demonstrated under 5% inter-user variability between radiologists for T1c and under 10% for FLAIR sequences. Furthermore, the AI models produced precise volume measurements and variability scores that align very closely with those measured by radiologists.

“This is truly a game-changer for a busy CNS radiation oncology practice. After thorough evaluation, I find it easy to learn, user-friendly, and seamlessly integrates into my workflow. Radiation oncologists often spend a significant amount of time contouring using manual platforms, which can result in substantial inter-user variability. The MRIMath Smart Contouring software is a breath of fresh air, offering low-variability, effective, and precise auto-contouring features. The MRIMath cyber device and AI streamline complex treatment planning workflows with high precision and robustness. The innovative features of MRIMath i2Contour will undoubtedly improve quality and advance patient care while also having the potential to lower healthcare costs,” stated Markus Bredel, M.D., Ph.D., Chairman and Sylvester Professor of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.

"MRIMath was exceptionally user-friendly. Additionally, I find it valuable that the software offers a secure, HIPAA-compliant cloud environment, enabling me to work from anywhere, collaborate on research projects, and consult with colleagues on special cases," stated Fanny Moron, M.D., Professor of Radiology, Baylor College of Medicine, Houston, Texas.

“My experience with MRIMath has been overwhelmingly positive, and I am consistently impressed by its performance. This platform has proven to be a game-changer in the management of glioma and glioblastoma patients,” stated Houman Sotoudeh, M.D., Associate Professor of Radiology, University of Alabama Birmingham, Birmingham, Alabama.

“MRIMath cyber device and GBM AI provide needed and advanced tools for the rapid, longitudinal computation of segmented imaging changes occurring in the central nervous system as a result of glioblastoma, the treatment of glioblastoma, or infiltration into the normal brain. This advance in technology will help improve the outcomes for patients with glioblastoma,” stated Burt Nabors, MD, Professor, Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama.

About MRIMath LLC

MRIMath LLC, based in Alabama, is committed to raising the bar in medical AI, offering reliable tools that help doctors make better decisions and improve patients' lives. The company continues to develop a full suite of AI models for cancer and neurosciences.

For more information visit: www.mrimath.com

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