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 Irregular Rhythm Notification Feature 2.0 (IRNF 2.0) is a software application used on Apple Watch and iPhone that analyzes pulse rate data using machine learning to detect irregular heart rhythms, such as atrial fibrillation (AFib). It notifies users of possible AFib episodes to help prompt medical consultation, supporting non-invasive heart rhythm monitoring through wearable technology.

FDA #
K212516
Product Code
QDB
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