Neosoma Announces FDA 510(k) Clearance for Neosoma HGG

Today, we are proud to announce that Neosoma HGG (High-Grade Glioma), our Software As A Medical Device (SaMD) for three-dimensional longitudinal tumor analysis and quantification, has received U.S. Food and Drug Administration (FDA) 510(k) clearance.

High-Grade Gliomas, which include Glioblastoma, are the most common, and most challenging, malignant primary brain cancers. In clinical practice, the brain MRI is the physician’s best tool to evaluate the details and changes in a brain tumor. However, even for the most experienced physicians this presents considerable challenges, which can have a direct impact on clinical care.

Neosoma HGG is the first technology of its kind to support neuro-oncology clinicians in improving treatment. Using advanced AI-based technology, Neosoma HGG produces precise and accurate brain tumor analysis on brain MRIs, providing physicians with critical insights to help them deliver optimal treatment.

To that point, Isabelle M. Germano, MD, MBA, FACS, Professor of Neurosurgery and Director of the Comprehensive Brain Tumor Program at the Icahn School of Medicine at Mount Sinai, New York, commented, “Clinicians commonly debate the results of brain MRIs and whether the brain tumor is stable, responding to treatment, or progressing. Neosoma HGG will give us the objectivity needed to make our decisions easier and more accurate."

Read our full press release for additional details.