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 Affirm 800 is a surgical imaging device that helps neurosurgeons visualize blood flow and vessel patency in the brain during operations. It works by using near-infrared light to activate a fluorescent dye (Indocyanine Green) injected into the bloodstream, allowing surgeons to see detailed images of cerebral vessels on a 3D monitor in real time. This aids in assessing occlusions and blood flow in vessels, improving surgical outcomes.
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