FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

The NvisionVLE Imaging System by NinePoint Medical, Inc. is a high-resolution optical coherence tomography (OCT) imaging device designed to visualize tissue microstructures, especially in the esophagus. It uses a specialized probe and advanced imaging software to provide clinicians with real-time, cross-sectional images of tissue, enhanced by AI-based segmentation to color-highlight important features. This helps clinicians better review and mark areas of interest in the tissue during evaluation, aiding in diagnosis and treatment planning.

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