Neosoma Brain Mets

by Neosoma  · Based in United States → — A new paradigm in the efficient assessment and auto-contouring of metastatic brain lesions for the entire multidisciplinary team.
Neurosurgery Oncology Radiology
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Contact for details; priced based on mri volume.
Regulatory Status Disclosed

Overview

Neosoma Brain Mets is an FDA-cleared AI-powered software medical device designed for the rapid MRI assessment and accurate, consistent analysis of brain metastases. It provides novel tumor insights to physicians and researchers in near-real-time, supporting radiology, radiation oncology, medical oncology, and surgical workflows, as well as tumor board decision-making. The technology identifies lesions as small as 1mm3 isotropic and can track any number of identified lesions over time. It operates on routinely-acquired T1 post-contrast sequences, requiring no special acquisition protocols. Neosoma Brain Mets auto-contours target (GTV) volumes and integrates seamlessly into radiation oncology and surgical planning software such as Eclipse, MIM, Brainlab, Gamma Plan, and Stealth. The platform is cloud-based, web-based, PACS-integrated, and offers an intuitive interface with interactive charts, 3D/2D visualizations, and smart segmentation/contour editing tools to expedite clinical case review. It is intended for use by qualified and trained medical professionals for informational purposes and not to replace manual contouring or detect tumors for diagnosis.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Rapid MRI assessment and analysis
  • Accurate and consistent lesion identification (as small as 1mm3 isotropic)
  • Near-real-time study processing
  • Longitudinal tracking of brain lesions over time
  • Operates on routinely-acquired T1 post-contrast sequences
  • Automated Gross Tumor Volume (GTV) contouring
  • Interoperability with radiation treatment and surgical planning software (e.g., Eclipse, MIM, Brainlab, Gamma Plan, Stealth)
  • Cloud-based, web-based, and PACS-integrated platform
  • Interactive charts, 3D/2D visualizations, and smart segmentation/contour editing tools
  • MRI protocol tolerant (no changes to acquisition protocols needed)
  • Reimbursable (Available Category 3 CPT Codes: 0865T, 0866T)

Use Cases

  • Assessment of brain metastases
  • Longitudinal tracking of brain lesions
  • Radiation treatment planning (GTV contouring)
  • Surgical planning
  • Tumor board decision-making
  • Clinical research and trials

What Physicians Need to Know

Brain MRI Analysis for Metastases
FDA-cleared AI for automatic detection, measurement, and tracking of brain metastases on MRI scans, providing quantitative metrics for lesion size and volume. It supports longitudinal assessment and automated Gross Tumor Volume (GTV) contouring for radiation oncology and surgical planning.
Triage & Workflow Prioritization
Delivers rapid MRI assessment with near-real-time study processing, streamlining workflows and reducing reporting burden. This automation aids in faster identification and potential prioritization of critical brain metastases cases.
Physician Tip

Leverage Neosoma Brain Mets for efficient and objective assessment of brain metastases, particularly for longitudinal tracking of disease progression and treatment response. Utilize its automated GTV contouring capabilities to streamline radiation oncology and surgical planning workflows. Always remember that AI-generated contours and measurements require clinical review and finalization by a qualified medical professional. The tool is intended to assist, not replace, clinical judgment and manual contouring.

Neosoma Brain Mets is designed for seamless integration into existing PACS and reporting workflows. It is also interoperable with various radiation treatment and surgical planning systems, such as Eclipse, MIM, Gamma Plan, and Stealth, allowing for easy import of lesion contours (GTVs). The platform is cloud-based, HIPAA compliant, and SOC2 Type II certified.

Details

Category Neurology AI, Oncology AI, Radiology & Imaging AI
Pricing Contact for details; priced based on mri volume. — Contact for details; priced based on MRI volume
DeploymentCloud-based, web-based interface.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

FDA 510(k) clearance (K252922) was received on December 17, 2025, for the semi-automatic segmentation of previously diagnosed brain metastases on MRI images for qualified and trained medical professionals.
Integrations
EHR Not specified
Specialties Neurosurgery, Oncology, Radiology

What the Web Says

Neosoma Brain Mets is an AI-powered software that assists in the accelerated detection, measurement, and contouring of brain metastases from routine MRI scans. It received FDA 510(k) clearance in December 2025 and is designed to integrate into radiology, radiation oncology, and neuro-oncology workflows. Physicians anticipate it will improve efficiency, objectivity in imaging, and longitudinal tracking of treatment response for patients with brain metastases.

Overall: Positive

Strengths

  • Accelerates metastasis identification, measurement, and contouring.
  • Provides enhanced detection and measurement of brain metastases.
  • Offers objective imaging in neuro-oncology.
  • Supports multidisciplinary teams in radiology, radiation oncology, medical oncology, and surgical workflows.
  • Automates gross tumor volume contouring and longitudinal lesion tracking.
  • Operates on routinely-acquired T1 post-contrast MRI sequences without special protocols.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, or tech reviewers.
  • No reviews or opinions from G2, Capterra, or Reddit directly discussing Neosoma Brain Mets were found, only general discussions about brain metastases.
  • FDA clearance does not equate to FDA approval, meaning the agency has determined it is equivalent to an already marketed product.

Based on reviews from: FDA Clears MRI-Based AI Software for Assessment of Brain Metastases, Neosoma Announces Receiving FDA 510(k) Clearance for Brain Mets - PRWeb, We Architected Neosoma's Fast Lane to FDA: A Modular Strategy Built for Rapid Repeat Clearances - Innolitics, FDA clears AI imaging tool for brain metastases - Becker's Oncology, Neosoma Brain Mets (neosoma.com), Groton medtech firm raises $3.5M for cancer-focused AI platform, FDA clearance brings Neosoma's brain tumor analytic device closer to market | BioWorld, Melanoma with brain Mets : r/CancerFamilySupport - Reddit, Looking for success stories about Brain Mets / Gamma Knife : r/lungcancer - Reddit, Life after Brain Metastasis : r/cancer - Reddit, New therapies for brain metastases: an update - PubMed, Hackensack Meridian Health Partners with Neosoma for Innovation in Brain Tumor Treatment, Research - PR Newswire, Stage IV brain met: two years update and the story so far : r/melahomies - Reddit, Brain mets - I'm terrified : r/CancerCaregivers - Reddit, Treating Cancer When It Spreads to the Brain, Brain metastases: A Society for Neuro-Oncology (SNO) consensus review on current management and future directions - PMC, An updated review on systemic therapy for brain metastases in non-small cell lung cancer - PMC, 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 - Business Wire, Value of Artificial Intelligence in Neuro-Oncology - PMC - NIH

Last updated: 2026-07-18

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Press & Coverage

PRWeb
Neosoma Announces Receiving FDA 510(k) Clearance for Brain Mets
Neosoma received FDA 510(k) clearance for its Brain Mets software medical device, which provides AI-based analysis for the assessment of brain metastases, offering novel tumor insights to physicians and researchers.
2025-12
AI News Today
FDA Clears a Wave of AI Tools for Brain MRI Scans
The FDA has cleared several AI tools for brain MRI, including Neosoma's Brain Mets software, which speeds the identification, measurement, and contouring of brain metastases from routine MRI.
2026-07
Worcester Business Journal
Groton medtech firm raises $3.5M for cancer-focused AI platform
Neosoma, a Groton-based medical technology company, raised $3.52 million in venture capital for its AI software that creates 3D analyses of cancerous tumors, with its Neosoma Brain Mets platform recently gaining FDA clearance.
2026-04
Innolitics
We Architected Neosoma's Fast Lane to FDA: A Modular Strategy Built for Rapid Repeat Clearances
Innolitics details its collaboration with Neosoma, highlighting the modular regulatory architecture that led to the efficient FDA 510(k) clearance of Neosoma Brain Mets in December 2025.
2025-09
accessdata.fda.gov
Neosoma Brain Mets 510(k) Premarket Notification
This FDA document outlines the 510(k) premarket notification for Neosoma Brain Mets, a Software as a Medical Device (SaMD) designed for the semi-automatic segmentation of previously diagnosed brain metastases.
2025-12
Neosoma News
Innolitics Publishes Case Study Highlighting Neosoma Collaboration
Innolitics published a case study detailing their collaboration with Neosoma, which likely focuses on the regulatory process for Neosoma's AI-driven medical devices.
2026-02
Neosoma News
Neosoma GmbH and Inselspital Announce Collaboration
Neosoma GmbH and Inselspital formalized and expanded their collaboration to advance oncology through AI-driven imaging analysis, including the deployment of Neosoma's software for brain metastases.
2025-11
Neosoma
AI-Powered Analysis Reveals New Predictors of Brain Cancer Survival
A study published in CNS Oncology, utilizing Neosoma's NSHGlio AI technology, demonstrated how AI and advanced imaging analysis can predict survival in patients with recurrent glioblastoma.
2024-12

Videos

Product demos, reviews, and walkthroughs for Neosoma Brain Mets.

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Frequently Asked Questions

Neosoma Brain Mets is a cloud-based, AI-powered software that integrates with PACS and is interoperable with radiation treatment and surgical planning systems. It streamlines the identification, measurement, and contouring of brain metastases from routine MRI scans, supporting radiology, radiation oncology, and surgical workflows.
Neosoma Brain Mets has received FDA 510(k) clearance as an AI-based software for the assessment of brain metastases. The platform is SOC2 Type II certified and HIPAA compliant, designed with best-in-class security practices to ensure patient data privacy and security.
Neosoma Brain Mets is intended for the semi-automatic segmentation of *previously diagnosed* brain metastases and for generating Gross Tumor Volume (GTV) contours, not for primary diagnosis. Clinicians must review and finalize the AI-generated contours, as the technology is meant to assist and not replace manual contouring.
Compared to traditional manual methods, Neosoma Brain Mets significantly accelerates lesion identification, measurement, and contouring, which are typically time-consuming processes. It provides consistent and objective analysis, offering enhanced detection and longitudinal tracking of individual lesions and total tumor burden.
Neosoma's solution is priced based on MRI volume, which allows multiple multidisciplinary team members to have access without incurring incremental seat license costs. Additionally, there are available Category 3 CPT codes (0865T, 0866T) that provide a reimbursement pathway for each MRI timepoint analysis.
No, Neosoma Brain Mets is not intended to replace the clinician's judgment or current standard practice of manual contouring. The software serves as an additional source of information to support clinical decision-making and research, requiring medical professionals to finalize and confirm or modify the generated contours.
Neosoma Brain Mets operates on routinely-acquired T1 post-contrast MRI sequences, requiring no special acquisition protocols. It is designed to be highly tolerant of real-world data and readily accepts prior patient studies, integrating seamlessly into existing imaging workflows.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

Investors who backed Neosoma Brain Mets

Funded through the company that built this tool.

Verge Healthtech Fund
VC T3
Singapore, Singapore
$250k-$1M
Verge Healthtech Fund is a Singapore-based early-stage healthtech specialist at verge.fund with a Singapore LinkedIn presence and active Crunchbase profile, focused on…
AI/ML in Healthcare Diagnostics
R3i Ventures
VC T3
Singapore, Singapore
$250k-$1M
R3i Ventures is the venture investment arm of R3i Capital, a healthcare-focused investment platform whose name and r3icapital.ai domain suggest a thesis…
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