Adjunctive AI Software for Brain MRI Gets FDA Clearance for Assessing High-Grade Gliomas
Incorporating artificial intelligence (AI)-based technology, Neosoma HGG reportedly demonstrated a 95.5 percent accuracy rate in measuring brain tumor volume on brain magnetic resonance imaging (MRI) scans at various points during the treatment of patients with high-grade gliomas.
The Food and Drug Administration (FDA) has granted 510(k) clearance for Neosoma HGG, an artificial intelligence (AI)-powered technology that may facilitate greater accuracy with the assessment of high-grade gliomas (HGGs) on brain magnetic resonance imaging (MRI).
Offering longitudinal tracking of patients with HGGs, Neosoma HGG provides tumor segmentation, facilitates imaging for 3D geometric analysis and performs volumetric measurements, according to Neosoma, the manufacturer of Neosoma HGG.
In performance testing, Neosoma said the Neosoma HGG exceeded the assessment of individual neuroradiologists with a 95.5 percent accuracy rate in measuring the volume of HGGs at different points during a patient’s treatment course.
The company said the detailed objective measurements provided by Neosoma HGG aid in operative planning and the assessment of post-op progress as well as the monitoring of chemotherapy treatment effectiveness.
“Clinicians commonly debate the results of brain MRIs and whether the brain tumor is stable, responding to treatment, or progressing. Neosoma HHG will give us the objectivity needed to make our decisions easier and more accurate,” added Isabelle M. Germano, MD, MBA, FACS, a professor of neurosurgery and the director of the Comprehensive Brain Tumor Program at the Mount Sinai Medical Center.
BrightHeart Garners Third FDA Clearance for AI-Powered Assessments of Fetal Heart Ultrasound
May 14th 2025The latest FDA 510(k) clearance is for B-Right Views, an AI-enabled device, which provides automated detection of required views necessary for second- and third-trimester fetal heart ultrasound exams.
