Neosoma, Inc. a Medical Technology Company Focused on Advancing the Treatment of Brain Cancers, Announced Today It Has Received U.S. Food and Drug Administration (FDA) 510(k) Clearance for Its First AI-Based Neuro-Oncology Software, Neosoma HGG

GROTON, Mass., September 29, 2022--(BUSINESS WIRE)--Neosoma, Inc., an innovative medical technology company focused on helping clinicians advance the treatment of brain cancers, announced today it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its first AI-based neuro-oncology software device, Neosoma HGG (High-Grade Glioma).

High-Grade Gliomas, which includes 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.

Neosoma HGG conducts detailed tumor segmentation, volumetric measurements, generates imaging for 3D geometric analysis and longitudinally tracks patients with high-grade glioma brain tumors. These features will help physicians to better plan procedures, assess post-procedural results, guide chemo and immunotherapy treatments and support an improved patient experience.

"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," commented Isabelle M. Germano, MD, MBA, FACS, Professor of Neurosurgery and Director of the Comprehensive Brain Tumor Program at The Mount Sinai Medical Center.

Performance testing results, submitted to the FDA, demonstrated that Neosoma HGG’s outputs exceeded that of individual neuro-radiology experts. When compared to a consensus of neuroradiologists, Neosoma HGG achieved an excellent 95.5% accuracy in measuring tumor volumes at multiple timepoints of patient care.

Neosoma HGG is combined with the proprietary Neosoma Clinical Management Software Platform, allowing the multi-disciplinary physician team more effectively centralize clinical data, plan and track patient care, and significantly increase efficiency.

"Neosoma HGG will give us a novel tool allowing for comprehensive longitudinal monitoring and understanding of brain tumors, assist in our decision making, and will be a valuable part of our clinical practice. I look forward to using this new and important technology," stated Roger Stupp, M.D., Chief of Neuro-oncology and Co-director of the Northwestern Medicine Malnati Brain Tumor Institute and Professor of Neurological Surgery, Neurology and Medicine at Northwestern University in Chicago, IL.


1 Hao-Wen Sim, Erin R Morgan & Warren P Mason, Contemporary management of high-grade gliomas. CNS Oncology, 2018 Feb; 7(1): 51–65

2 National Brain Tumor Society

About Neosoma, Inc.

Neosoma is focused on advancing the treatment of brain cancers through an integrated portfolio of innovative, artificial intelligence-based software products combined with a Clinical Management Software Platform. Neosoma’s comprehensive SaaS solution is first-of-its-kind technology in the neuro-oncology space, helping physicians to make better treatment decisions with the goal of improving clinical outcomes.

Starting with its initial software based medical device, Neosoma HGG, the company is developing a full suite of software technologies to become the global leader in the neuro-oncology software field.

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John Liedtky
Chief Strategy and Commercialization Officer, Neosoma, Inc.