Natural Cycles today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its use of wrist temperature data from Apple Watch. The integration will allow the Natural Cycles app, an FDA Cleared Class II medical device in the U.S., to use overnight wrist temperature data from Apple Watch (Series 8 and later and all models of Apple Watch Ultra) for users consenting to share this information. The integration has also been cleared by regulators in Europe and has been registered for use in Australia.
The Natural Cycles app is used to prevent and plan pregnancy naturally without hormones. There are six days each cycle a woman can become pregnant and the app is powered by an algorithm that analyzes daily hormone-driven temperature changes to confirm if the user is fertile that day or not. To receive their temperature-powered daily fertility status, users can manually take their body temperature with a thermometer or sync temperature data from an integrated wearable device when they wake up.
In September 2022, Apple introduced temperature-sensing capabilities to Apple Watch with the release of Apple Watch Series 8 and Apple Watch Ultra. Apple Watch (Series 8 and later and all models of Apple Watch Ultra) takes a unique approach to temperature sensing with a two-sensor design, and uses the temperature-sensing capabilities to enable users to receive retrospective ovulation estimates and improved period predictions. Apple's Cycle Tracking experience is not intended to be used as a form of birth control.
Natural Cycles is the only app on the market that's been cleared by the FDA to be used and marketed as birth control.
Natural Cycles received clearance to be marketed as birth control in 2018 through the FDA's de novo premarket review pathway. It received 510(k) clearance in 2021 to integrate with third-party wearables using Oura Ring data. This latest 510(k) clearance uses Apple Watch wrist temperature data, clearing the app to work with the Apple Watch in the U.S. The Natural Cycles app has also been reviewed and cleared to be used as a contraceptive alongside Apple Watch and the Oura Ring in Europe and registered in Australia.
As part of this FDA 510(k) review process, Natural Cycles demonstrated that its app complies with the new cybersecurity requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). As a medical device, Natural Cycles is committed to keeping users' data safe and earlier this year launched NC° Secure, a comprehensive privacy protection program.
Users must explicitly choose to share overnight wrist temperature data measured by Apple Watch from the Apple Health app with the Natural Cycles app and can manage permissions at any time. Users can also choose which data from the Natural Cycles app, if any, they'd like to share to the Health app. Once in the Health app, a user's data is securely stored and the user is in control of who can access their data.