About Galileo CDS, Inc
Galileo CDS, Inc. is a medical imaging AI company specializing in neuroradiology solutions. The company's flagship product, GBrain MRI, is a fully automated post-processing medical device that performs segmentation, quantification, and reporting of signal hyperintensities in brain MRI scans. Unlike competing solutions, GBrain is disease-agnostic and location-agnostic, meaning it can analyze any FLAIR hyperintensity anywhere in the brain—including white matter, gray matter, deep gray matter, cortex, and tumor-infiltrated parenchyma—without requiring a prior diagnosis or disease-specific restrictions. GBrain MRI holds two independent FDA 510(k) clearances obtained in 2025: K250416 for T2w FLAIR signal hyperintensity quantification, and K252362 for contrast-enhancing lesion measurement using T1w post-contrast sequences. The platform is designed as a headless computing appliance that integrates seamlessly into existing radiology workflows via DICOM, with no cloud dependency after installation, no separate workstation requirements, and no user-facing interface. The company also offers Galileo Education, a web-based PACS environment with curated clinical cases designed to augment radiology resident training. Founded by radiologists with over 100 years of combined expertise in neuroradiology, radiology workflow design, and computational imaging, Galileo CDS focuses on building tools that advance neuroradiology practice while minimizing IT friction and workflow disruption. The platform supports clinical applications across the full spectrum of brain pathology, including white matter disease, multiple sclerosis, brain tumors, neuroinflammatory conditions, dementia, and general neuroradiology indications.
Mission & Story
Founding Story
Founded on over two decades of research in neuroradiology and cutting edge medical image analysis by radiologists with more than 100 years of combined expertise in neuroradiology, radiology workflow design, and computational imaging.
Clinical Focus
Medical conditions and clinical areas addressed by Galileo CDS, Inc.
Who It Serves
Milestones & Awards
Recent Milestones
Two FDA 510(k) clearances obtained in 2025: K250416 (April 2025) for FLAIR hyperintensities and K252362 (August 2025) for contrast-enhancing lesions
Company Details
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