Neosoma Receives 510(k) Clearance for Neosoma HGG Software
Groton, Mass.-based Neosoma has received 510(k) marketing clearance from the FDA for its Neosoma HGG (high-grade glioma) software.
The software uses artificial intelligence to analyze magnetic resonance imaging (MRI) scans of the brain to evaluate brain tumors, providing detailed tumor segmentation and volumetric measurements. It also generates 3D imaging analysis that tracks patients with high-grade glioma brain tumors.
When compared to a consensus of neuroradiologists, Neosoma HGG achieved 95.5 percent accuracy in measuring tumor volumes at multiple timepoints of patient care, the company said.