It is alleged that, Natural Cycles has received 510(k) clearance from the US Food and Drug Administration (FDA) for its use of wrist temperature data from the Apple Watch. This clearance allows the Natural Cycles app, which is an FDA-approved Class II medical device, to integrate with the Apple Watch and use overnight wrist temperature data for users who consent to sharing this information.
The Natural Cycles app is designed to prevent and plan pregnancy naturally and without hormones. It works on an algorithm that analyzes daily hormone-driven temperature changes in a woman’s body to determine whether she is fertile or not on any given day. Users can choose to manually take their body temperature with a thermometer or sync temperature data from an integrated wearable device like the Apple Watch.
Dr. Elina Berglund Scherwitzl, co-founder and CEO of Natural Cycles, expressed excitement about this integration, stating that many users had requested it after Apple introduced temperature sensing capabilities to the Apple Watch Series 8 and Apple Watch Ultra in September 2022. She also highlighted the importance of birth control accessibility, especially during these times.
It’s important to note that while Apple’s Cycle Tracking experience can provide retrospective ovulation estimates and improved menstrual cycle predictions, it is not intended to be used as a form of birth control. Dr. Jill M. Samale emphasizes that women should consult their doctors about their reproductive health goals and consider options backed by clinical evidence and certified by the FDA.
Natural Cycles received authorization as a contraceptive method in 2018 through the FDA’s de novo premarket review pathway. In 2021, it obtained 510(k) clearance to integrate with third-party wearables using Oura Ring data. With this latest clearance, Natural Cycles can now work with the Apple Watch in the US as well.
Dr. Raoul Scherwitzl, co-founder and CEO of Natural Cycles, highlights the company’s commitment to collecting high-quality clinical evidence and ensuring user safety. He praises the FDA’s thoroughness in adapting to the rapidly changing digital health environment, including its increased focus on cybersecurity.
As part of the FDA 510(k) review process, Natural Cycles demonstrated compliance with the new cybersecurity requirements of the FD&C Act. The company also launched NC° Secure, a comprehensive privacy protection program, earlier this year to ensure the security of user data.
It is important to note that users have control over their data and must explicitly choose to share overnight wrist temperature data measured by Apple Watch with the Natural Cycles app. They can manage permissions and decide which app data they want to share with the health app. Once in the health app, a user’s data is securely stored.
This integration between Natural Cycles and Apple Watch provides an additional option for women who are looking for natural contraceptive methods. It combines technology and fertility tracking algorithms to help users make informed decisions about their reproductive health.
In aggregate, this clearance from the FDA highlights the growing role of digital health technologies in providing accessible and effective solutions for women’s reproductive health. With more regulatory bodies recognizing these innovations, it opens up possibilities for further advancements in this field.
The culmination, Natural Cycles has received FDA clearance to integrate with Apple Watch using wrist temperature data. This integration allows users of the Natural Cycles app to benefit from temperature sensing capabilities of Apple Watch Series 8 and later models for fertility tracking purposes. With this development, women have another option for natural birth control methods that leverage technology for accurate tracking and analysis of fertility patterns.
Note: The information provided in this article is based on the source mentioned above and does not constitute medical advice. Users should consult healthcare professionals for personalized guidance regarding contraception or reproductive health goals.
