Natural Cycles has made waves by successfully integrating its FDA-approved birth control app with the Apple Watch, using wrist temperature data as a predictor of fertility. This groundbreaking integration allows users of Apple Watch Series 8 and newer models, as well as all versions of the Apple Watch Ultra, to effortlessly assess their daily fertility status.
Natural Cycles’ app, a hormone-free approach to family planning, pinpoints the six days of a woman’s cycle where conception is possible. The app’s advanced algorithm reviews hormone-driven temperature fluctuations daily to confirm fertility status. With this integration, users can either manually log their body temperature or simply sync their Apple Watch’s temperature readings upon waking up.
Dr. Elina Berglund Scherwitzl, co-founder and CEO of Natural Cycles, expressed her enthusiasm for the partnership. “When Apple incorporated temperature-sensing features into its Apple Watch Series 8 and Apple Watch Ultra, our user base immediately expressed interest in an integration. Following clinical evaluations of wrist temperature data’s reliability, we confidently approached the FDA. With their clearance, we’re thrilled to offer our users a more streamlined way to assess their fertility using a device many already own and trust. Especially in these times when birth control access is paramount, this partnership extends vital fertility insights to millions of women worldwide.”
Apple’s foray into temperature-sensing technology began in September 2022 with the unveiling of the Apple Watch Series 8 and Apple Watch Ultra. This unique dual-sensor design offers users retrospective ovulation estimates and refined period predictions. It is essential to note, however, that Apple’s Cycle Tracking experience isn’t designed as a contraceptive method.
Natural Cycles is the only app on the market that’s been cleared by the FDA to be used and marketed as 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. “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 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 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,” said Natural Cycles co-founder and CEO Dr. Raoul Scherwitzl. “Medical device regulations were established to keep users safe. 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.