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 Belun Sleep System BLS-100 is a wearable device designed for adult patients suspected of sleep apnea. It consists of a sensor ring worn on the user's index finger overnight to collect biophysical signals such as oxygen saturation and pulse, which are then analyzed by AI-powered software to help healthcare professionals assess the severity of sleep-related breathing disorders in both clinical and home settings.
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