Natural Cycles wants to integrate its contraceptive app with wearables and is seeking FDA approval

Natural Cycles is the first digital contraceptive APP to be approved by the U.S. Food and Drug Administration. This time, the company asked the agency to authorize integration with wearables such as Ora Ring. This feature makes it easier for users to use the app correctly, but it doesn’t avoid some existing app-based issues.

Natural Cycles wants to integrate its contraceptive app with wearables and is seeking FDA approval

The Natural Cycles app uses daily temperature measurements and menstrual cycle tracking to predict the day when someone is least likely to get pregnant. Users track when they will ovulate and use this information to calculate when they have the best chance of conceive. App users take their body temperature manually every day, just as they get up in the morning. The new feature allows users to pair apps with wearable devices to measure their body temperature.

“We do see some users who have a hard time remembering to take their body temperature in the morning,” said Elina Berglund, co-founder and CEO of Natural Cycles. “We listened to our users and they said, you know, if there’s something that can be put on at night and measured, so they don’t have to remember it in the morning.”

Anyone who uses the app to track their fertility can now use the feature through a test plan. Using the app as a birth control person, Berglund says about 75 percent of users can’t use it — Natural Cycles first needs FDA approval. Now, the app is only approved as a basic thermometer for birth control, which tracks smaller temperature increments than regular thermometers.

The FDA’s initial decision to approve Nature Cycles in 2018 was controversial: some Swedish users became unwanted after using the app and promoted it on social media. Fertility awareness can be an effective method of birth control, but to use this technique, people often have to learn to track and interpret their daily temperature and other reproductive signals, such as cervical mucus. Experts say it’s not easy to turn this careful tracking into an app, and it’s not a good choice for everyone — people with menstrual cycles or inconsistent sleep times, for example.

Natural Cycles uses only temperature to measure fertility signals, and it does not include other indicators, such as cervical mucus. Studies have shown that tracking only one signal is often less accurate than tracking both signals at the same time. “Temperature is not the king of fertility awareness,” said Rebecca Simmons, a researcher and fertility awareness expert at the University of Utah.

Measuring temperature using wearable devices like Ora Ring adds another layer of automation to fertility awareness. This has some drawbacks: it brings the app one step closer to the body knowledge that is the basis of the reproductive consciousness approach. But it can help application users get more accurate and consistent temperature readings, Simmons said. A wearable device measures temperature continuously, not just at one moment. She says it may be less likely to be affected by changes when someone doesn’t go to bed, or if they drink the night before.

However, these benefits are only those that Arera Ring does when it makes high-quality temperature measurements. Natural Cycles has completed an internal study of Ora Ring temperature readings, but they haven’t released the data yet, Berglund said. A small study of 22 women last year found that the temperature measured by Oura Ring was proportionable. But research is still limited. “There’s a long way to go before we can feel, yes, that these really tell us what we need to know to predict our fertility.” Simmons said.

The potential benefits, she says, have not elevated the app to a more comprehensive approach to fertility awareness. “The benefits outweigh the disadvantages only if you’re already using this (application-based) approach, which has taken you away from this reproductive knowledge.”

Working with third-party wearables can also make it harder for users to understand where their data is going. If only included in the Nature Cycles app, there is only one privacy policy and a set of terms and conditions. Adding another device to the equation brings another set of rules. “It just creates a more confusing space for people to try to understand their right to privacy than these apps,” Simmons said.

Natural Cycle’s application to the FDA is not specific to Aura Ring – it is open and will integrate the app with any wearable device that measures temperature. “If we do a small internal study to validate a wearable device and see that it can provide the same mass as an oral thermometer, then it can be used for Nature Cycles,” Berglund said.

Assuming FDA approval, Berglund said, the company will evaluate the use of wearable integration and how effective it will be, both under testing and in full rollout. Simmons says it’s one of the things she admires about Nature Cycles. “They’re really trying to publish their work, they’re trying to use the right channels.”

Simmons: “We have to have bigger, longer-term, better research to make sure we have confidence,” she said. “I think there’s still too little data to have a lot of confidence that the technology is where it needs to move forward.”