FDA clears cyber device, AI system to address glioblastoma

An Alabama-based company announced that the FDA has granted 510(k) clearance to its cyber device and AI system, which are designed to improve efficiency and accuracy of glioblastoma care.

According to a release from MRIMath LLC, which is funded by the National Cancer Institute, its i2Contour device delivers AI-powered tools that aim to save physicians time when evaluating brain imaging, allowing for more rapid patient care.

I2Contour offers neuro-based health care professionals quicker labeling and volume measurement time for glioblastoma, safety and security compliance with FDA standards for medical data management, organizational workflow for ease of collaboration, precision monitoring capabilities for patient treatment planning, MRIMath said in the release.

According to statistics cited in the release, MRIMath Smart’s manual contouring platform demonstrated under 5% inter-user variability between radiologists for T1c and under 10% for FLAIR sequences, with AI models producing precise volume measurements and variability scores comparable with those made by radiologists.

“MRIMath cyber device and [glioblastoma] 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,” Burt Nabors, MD, professor in the department of neurology and neuro-oncology at the University of Alabama at Birmingham, said in the release. “This advance in technology will help improve the outcomes for patients with glioblastoma.”