Natural Cycles receives FDA Clearance to integrate its birth control app with Apple Watch
Natural Cycles users can now confirm their daily fertility status using wrist temperature from a compatible Apple Watch
Natural Cycles, the leading women’s health company that developed the world’s first birth control app, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Apple Watch integration. The integration will allow the Natural Cycles app, an FDA Cleared Class II medical device in the U.S., to sync wrist temperature data from users who wear an Apple Watch with temperature-sensing capabilities overnight. 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. The Apple Watch will be the second integrated wearable device that can be used with the Natural Cycles app after the company received FDA clearance to integrate with smart ring innovator OURA in 2021.
“Immediately following the addition of temperature-sensing capabilities to the Apple Watch, 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 powered by Apple Watch,” said Natural Cycles co-founder and CEO Dr. Elina Berglund Scherwitzl. “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 an 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. Taking a unique approach to temperature sensing with a two-sensor design, wrist temperatures collected from Apple Watch help deliver insights into users' health, including the menstrual cycle. Apple’s Cycle Tracking app can use wrist temperature data to improve period predictions and provide retrospective ovulation estimates. It 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.
“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 for use alongside the Apple Watch in the U.S. The Natural Cycles app has also been reviewed and cleared to be used as a contraceptive alongside the Oura Ring and Apple Watch in Europe and registered in Australia.
“As a company founded by scientists, we embrace the need to collect high-quality clinical evidence needed 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 the Apple Watch integration 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.
About Natural Cycles°
Natural Cycles is a leading women’s health company that developed the world’s first birth control app. As a Class II medical device, the NC° app is cleared by the FDA in the United States and certified to be used as a contraceptive in Europe, Australia, and Singapore. For a monthly or annual subscription fee, users have access to and can switch between NC° Birth Control, NC° Plan Pregnancy, and NC° Follow Pregnancy modes within the app. NC° Birth Control’s contraceptive effectiveness is 93% effective with typical use and 98% effective with perfect use. Natural Cycles also leverages the technology used to power the NC° app to offer fertility-as-a-service to third-party partners, allowing partners to provide clinically validated fertility tracking features to their users. Founded in 2013 by Physicists Dr. Elina Berglund and Dr. Raoul Scherwitzl, Natural Cycles is committed to pioneering women’s health with research and passion. The company’s on-staff research team has contributed to 16 peer-reviewed research papers. For more information on the company, its scientific research, or how the NC° app works, visit naturalcycles.com.