FDA Clears Natural Cycles Birth Control App for Use with Apple Watch

Natural Cycles, a company that developed the world’s first birth control app, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance to use wrist temperature data from the Apple Watch.
 
The integration lets the Natural Cycles app to use overnight wrist temp data from Apple Watch (Series 8 and later, and all Apple Watch Ultra models) for users that consent to share the information. The integration was also cleared by European regulators and is registered for use in Australia.
 
The Natural Cycles app helps users prevent and plan pregnancy without hormones. The app contains an algorithm that analyzes daily, hormone-driven temp changes to confirm whether the users is fertile that day or not.

In September 2022, Apple released temperature-sensing capabilities to Apple Watch with the release of Series 8 and Ultra. These Apple Watch versions feature a two-sensor design, and use the temperature-sensing capabilities to let users receive retrospective ovulation estimates and improved period predictions.
 
Users can either manually take body temperature with a thermometer or sync the temperature data from an integrated wearable device when they awaken.
 
“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,” Natural Cycles co-founder and CEO Dr. Elina Berglund Scherwitzl told the press. “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.”
 
The company said Natural Cycles is the only app on the market cleared by the FDA to be used and marketed as birth control.
 
“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.”
 
Disclaimer: 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.