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Neosoma, Inc., a medical technology company focused on advancing the treatment of brain tumors, today received U.S. Food and Drug Administration (FDA) 510(k) clearance for its first AI-based neuro-oncology software, Neosoma HGG announced that it did.

Groton, MA–(business wire)– Neosoma, Inc., an innovative medical technology company focused on helping clinicians advance the treatment of brain tumors, announced today that the U.S. Food and Drug Administration ( FDA) announced that it has received 510(k) clearance. Oncology software device, Neosoma HGG (high grade glioma).

High-grade gliomas, including glioblastoma, are the most common and most challenging malignant primary brain tumors. In clinical practice, brain MRI is the best tool for physicians to assess details and changes in brain tumors. However, even for the most experienced physicians, this presents considerable challenges that can directly impact clinical care.

Neosoma HGG It’s the first technology of its kind Helping neuro-oncology clinicians improve their care. Using advanced AI-based technology, Neosoma HGG provides accurate and precise brain tumor analysis on brain MRIs, providing key insights to help physicians provide optimal treatment.

Neosoma HGG performs detailed tumor segmentation, volumetric measurements, produces images for 3D geometric analysis, and longitudinally tracks patients with high-grade glioma brain tumors. These capabilities help physicians better plan procedures, assess post-procedure outcomes, guide chemotherapy and immunotherapy treatments, and help improve the patient experience.

“Clinicians commonly discuss brain MRI results with whether brain tumors are stable, responding to treatment, or progressing. It gives us the objectivity we need,” commented Isabel M. Germano, MD, MBA, FACS, Professor of Neurosurgery and Director of the Comprehensive Brain Tumor Program at Mount Sinai Medical Center.

Performance test results submitted to the FDA showed that the output of Neosoma HGG exceeded that of individual neuroradiology professionals. Compared to neuroradiologist consensus, the Neosoma HGG achieved an excellent accuracy of 95.5% for him in measuring tumor volume at multiple points of patient care.

Combined with the proprietary Neosoma clinical management software platform, Neosoma HGG enables multidisciplinary teams of physicians to more effectively centralize clinical data, plan and track patient care, and significantly improve efficiency. increase.

“Neosoma HGG will provide a new tool to enable comprehensive longitudinal monitoring and understanding of brain tumors, aid decision-making, and will become a valuable part of clinical practice.” I am looking forward to it,” said Roger Rogers, chief of neuro-oncology at Northwestern University in Chicago, co-director of the Munati Brain Tumor Institute of Northwestern Medicine, and professor of neurosurgery, neurology and medicine. Stupp, M.D., said. Illinois.


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

2 American Brain Oncology Society

About Neo Soma Co., Ltd.

Neosoma is focused on advancing the treatment of brain tumors through an integrated portfolio of innovative artificial intelligence-based software products combined with a clinical management software platform. Neosoma’s comprehensive SaaS solution, a first-of-its-kind technology in neuro-oncology, helps physicians make better treatment decisions with the goal of improving clinical outcomes.

Starting with the first software-based medical device, Neosoma HGG, the company has developed a complete suite of software technologies to become a global leader in neuro-oncology software.

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