Self-care monitoring web-based application software

Intended purpose

The Sleep Apnoea Notification Feature (SANF) is a software-only mobile medical application that analyzes Apple Watch sensor data to identify patterns of breathing disturbances suggestive of moderate-to-severe sleep apnoea and provides a notification to the user. This feature is intended for over-the-counter (OTC) use by adults age 18 and over who have not previously received a sleep apnoea diagnosis and is not intended to diagnose, treat, or aid in the management of sleep apnoea. The absence of a notification is not intended to indicate the absence of sleep apnoea.