VBrain
FDA cleared AI-powered brain tumor auto contouring solution
Company profile
Company profile
Vysioneer is an oncology AI company headquartered in Cambridge, MA, with a mission to use machine learning to bring therapies to cancer patients in need sooner. The company was founded on the belief that every tumor matters in the fight against cancer, addressing the critical challenge that 60% of cancer patients develop a mixture of shrinking, stable, and growing tumors—a phenomenon known as tumor heterogeneity that poses significant obstacles to personalized cancer medicine. Powered by their FDA-cleared, cloud-based AI platform, Vysioneer enhances drug efficacy assessment with lesion-level precision. Their AI-powered approach extracts all-lesion features beyond current response evaluation criteria and explores biomarkers that predict treatment outcomes. This enables pharmaceutical companies to conduct oncology trials with smaller sample sizes and confirm treatment outcomes sooner, while helping clinicians identify the right treatment for the right patient at the right time. Vysioneer's flagship product, VBrain, is an FDA-cleared AI-powered brain tumor auto-contouring solution that applies automated contouring to the three most common types of brain tumors: brain metastasis, meningioma, and acoustic neuroma. Clinical studies published in Neuro-Oncology demonstrated that clinicians assisted by VBrain showed a 12.2% increase in lesion detection, with fully automated contours generated in one minute compared to hours of manual work. The company serves both pharmaceutical/biotech companies for clinical trial optimization and healthcare providers for improved treatment planning and patient care.
Company description Vysioneer official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Cloud Saas deployment with recorded integration context.
Company milestones
ESMO Congress 2025 presentation in collaboration with Pfizer (October 2025). Research featured in ESMO Daily Reporter (October 2025). FDA clearance obtained for VBrain.
Partnerships
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
FDA cleared AI-powered brain tumor auto contouring solution
Cloud-based AI platform for lesion-level oncology trial insights
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
CPT: pharmacometrics & systems pharmacology · Jun 1, 2026
Stratified assessment of an FDA-cleared deep learning algorithm for automated detection and contouring of metastatic brain tumors in stereotactic radiosurgery.Radiation oncology (London, England) · Apr 4, 2023
Local control of brain metastases with osimertinib alone in patients with EGFR-mutant non-small cell lung cancer.Journal of neuro-oncology · Oct 1, 2022
Randomized multi-reader evaluation of automated detection and segmentation of brain tumors in stereotactic radiosurgery with deep neural networks.Neuro-oncology · Sep 1, 2021
Clinical validation
No linked records are currently available.
Regulatory
K213628 · 510k · Dec 16, 2021
VBrain-OARK212116 · 510k · Oct 12, 2021
VBrainK203235 · 510k · Mar 19, 2021
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Clinicians assisted by VBrain in randomized multi-reader evaluation
Fully automated contours generated in one minute
AI-powered treatment efficacy assessment incorporating all lesions
Automated contouring for treatment planning
AI-derived early response assessment in oncology trials
Research collaboration featured at ESMO Congress 2025
Brain tumor detection and segmentation in stereotactic radiosurgery
12.2% increase in lesion detection accuracy with VBrain assistance
05 · Leadership
Leadership profiles and professional links from the current Company record.
Jen-Tang (JT) Lu
Founder and CEO
Roger W. Ferguson, Jr.
Business Advisor
Joe Chang
Business Advisor
Christopher Ballesteros
Business Advisor
Chih-Han Yu
Business Advisor
Lawrence Leighton
Business Advisor
Peter Steiger
Business Advisor
Erqi Pollom
Medical Advisor
06 · Company updates
Recent articles published on Vysioneer's official website.
No Company updates are currently listed.
07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
Companies using AI, machine learning, or computational biology to discover new drug candidates, identify drug targets, predict drug efficacy, or accelerate pharmaceutical development. Includes both small molecule and biologics development, precision oncology drug discovery, and AI-driven target identification and molecule design.
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