Natural Cycles, the company that developed the world’s first birth control app, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its use of wrist temperature data from Apple Watch.
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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 analyses 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 choose to manually take their body temperature with a thermometer or sync temperature data from an integrated wearable device when they wake up.
Natural Cycles co-founder and CEO Dr. Elina Berglund Scherwitzl said: “Immediately following the addition of temperature-sensing capabilities to Apple Watch Series 8 and Apple Watch Ultra, our users began asking for this integration so our team began clinical evaluations to validate the quality of the wrist temperature data to determine whether we could deliver Natural Cycles birth control using data from Apple Watch. We were thrilled with the results, submitted them to the FDA, and with this clearance are excited to give our users the ability to seamlessly measure using a device many already own and love. And at a time when birth control accessibility has never been more important, we’re excited to give millions of women who already own a supported Apple Watch access to deeper fertility insights.”
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 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.
Dr. Jill M. Samale, MD, FACOG, said: “While cycle tracking apps can be helpful tools, not all apps are created equal and should only be used as intended. 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.”
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 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 for use in Australia.
Natural Cycles co-founder and CEO Dr. Raoul Scherwitzl said: “As a company founded by scientists, we embrace the need to collect high-quality clinical evidence to make users and regulatory bodies like the FDA feel comfortable with the innovative technologies we’re developing. Medical device regulations were established to keep users safe, and we continue to be impressed with the FDA’s thoroughness and ability to adapt in a rapidly changing digital health environment, including their increased focus on cybersecurity, which is of utmost importance for all digital products, especially within women’s health.”
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.
