In an age where technology continues to make strides in healthcare, the FDA has given the green light for the Apple Watch to be used with Natural Cycles, a digital birth control application. This is a significant development for users of the Natural Cycles app who own an Apple Watch Series 8, 9, Ultra, or Ultra 2, as they can now directly import their temperature data from the watch, eliminating the need for manual input each morning. This is the second FDA-approved wearable integration for Natural Cycles, with the first being the Oura Ring, highlighting the technological advances in reproductive health tracking.

The integration of the Apple Watch, which commanded a hefty 30 percent of the global smartwatch market in 2022, is a milestone. Apple introduced temperature sensors on its Series 8 watches, a unique feature incorporating two sensors – one positioned just beneath the display and the other closer to the skin. The first sensor takes ambient temperature readings to help eliminate environmental bias, while the other enables advanced cycle tracking with retrospective ovulation estimates. This feature is particularly noteworthy for the Natural Cycles app, which relies on daily temperature data to inform users of their fertility status through an algorithm.

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

The US Food and Drug Administration (FDA) has given the green light to the Apple Watch for integration with Natural Cycles, a digital birth control app. This clearance allows users of the Apple Watch Series 8, 9, Ultra, and Ultra 2 to import their temperature data directly from their wearable device, replacing the need for manual basal body temperature measurements each morning. This is the second wearable integration for Natural Cycles, following its FDA-approved collaboration with the Oura Ring.

The Significance of Apple Watch Integration

The integration with Apple Watch is a significant step, considering Apple’s commanding position in the global smartwatch market, with a 30 percent share in 2022. It was in this year that Apple first introduced temperature sensors on its Series 8 models. Unlike other smartwatches, Apple’s design included two temperature sensors—one beneath the display for ambient temperature readings and another closer to the skin. These sensors also facilitate advanced cycle tracking with retrospective ovulation estimates.

How Natural Cycles Works

The Natural Cycles app requires users to input daily temperature data, either from a basal body temperature thermometer or a compatible wearable device. This data is then processed through an algorithm to inform users about their fertility status. The app is currently the only FDA-cleared digital birth control app and is classified as a Class II medical device, indicating a moderate to high risk to the user. This category also includes devices like blood pressure cuffs, contact lenses, and smartwatch EKG features used for detecting atrial fibrillation.

User Demand for Apple Watch Integration

Natural Cycles CEO Elina Berglund Scherwitzl stated that the company received numerous requests from users for Apple Watch integration after the launch of the Series 8 with its new temperature sensors. However, this feature is only available on the Series 8 and 9 and the Ultra models, as older Apple Watch models and the SE models do not include temperature sensors.

A Trend in Reproductive Health Tracking

The use of wearable temperature data in reproductive health tracking is becoming increasingly popular. Natural Cycles first ventured into "wearable birth control" in 2020 and received FDA clearance for the technology in 2021. The company secured clearance for Oura Ring integration last year and earlier this year collaborated with Samsung to adapt its algorithm for advanced cycle tracking on Samsung’s Galaxy Watch 5 and 6 series smartwatches. However, the Galaxy Watches are not compatible with Natural Cycles’ birth control features.

Controversies and Considerations

Despite its advancements, Natural Cycles has faced controversy. The FDA’s initial clearance of its digital birth control feature in 2018 sparked backlash after the app was linked to 37 unwanted pregnancies at a single hospital in Sweden. Furthermore, reproductive health apps have been under increased scrutiny in the US following the Supreme Court’s reversal of Roe v. Wade in 2022.

For the Apple Watch integration, Natural Cycles had to submit clinical evaluations to the FDA via the agency’s 510(k) review process, and provide proof of compliance with cybersecurity requirements for data privacy. The company also received clearance from European regulators and has registered the app for use in Australia.

However, regulatory clearance does not guarantee infallibility. While the use of wearable temperature data may reduce user error and provide more consistent data, it still requires proper use of the app. Any user error could potentially result in unwanted pregnancies.

Takeaways

The integration of wearable technology with reproductive health apps presents a significant step forward in personal health management. While these advancements offer convenience and potential for improved accuracy, they also underscore the importance of understanding and correctly using these technologies. As wearable tech continues to evolve, users and regulators alike must stay vigilant about potential risks and ensure that these devices are used responsibly and effectively.