The Natural Cycles app has received 510(k) clearance from the US Food and Drug Administration (FDA) to use wrist temperature data from Apple Watch.
The integration will be classed as a Class II device and will have access to overnight wrist temperature data from the Apple Watch (Series 8 and later, as well as all models of Apple Watch Ultra). The app has also received device clearance for use in Europe and Australia.
The company noted that it has shown compliance with the new cybersecurity requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as part of the FDA clearance. Natural Cycles also noted that it required explicit consent to use Apple Watch’s health data.
The Natural Cycles app was first cleared as a birth control device through the FDA’s de novo premarket review pathway in 2018. In 2021, it was cleared to be integrated with third-party wearables using Oura Ring data in the US, Europe, and Australia.
The app tracks daily hormone-driven temperature changes to assess the user’s fertility. Apart from the overnight Apple Watch wrist temperature data, users can also manually add their body temperature to assess fertility.
The regulated mobile health app market is expected to reach $12.1bn by 2023, as per GlobalData. Ava Sciences has also conducted clinical trials for its wearable fertility tracking device, Fertility Tracker.
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Apple Watch assesses the user’s wrist temperature by using two sensors which can be used to track ovulation and periods. However, Apple’s Cycle Tracking is not cleared by the FDA as a birth control.
“While cycle tracking apps can be helpful tools, not all apps are created equal and should only be used as intended,” said Dr Jill M Samale, MD, FACOG (Fellow of the American Congress of Obstetricians and Gynecologists).
“It’s important that women feel comfortable talking to their doctor about their reproductive health goals and that providers have options backed by clinical evidence and certified by the FDA to help support those goals.”