The FDA has approved the use of the Apple Watch with the Natural Cycles app, a digital birth control app. This means that users of Natural Cycles who own certain models of the Apple Watch can now import their temperature data from the watch instead of manually taking their temperature each morning. This is the second FDA-cleared wearable integration for Natural Cycles, with the first being the Oura Ring.
The Apple Watch integration is significant because Apple holds about 30% of the global smartwatch market, and their Series 8 introduced temperature sensors. These sensors allow for advanced cycle tracking and retrospective ovulation estimates.
The Natural Cycles app requires users to input daily temperature data into an algorithm that informs them of their fertility status. It is the only FDA-cleared digital birth control app and is classified as a Class II medical device.
Natural Cycles co-founder and CEO, Elina Berglund Scherwitzl, stated that users requested an Apple Watch integration once the Series 8 was released. However, only the Series 8 and 9 and Ultra models are compatible with this feature.
Using wearable temperature data for reproductive health tracking is a growing trend. Natural Cycles previously integrated with the Oura Ring and partnered with Samsung for their Galaxy Watch 5 and 6 series smartwatches.
While the FDA has cleared Natural Cycles, the app has faced controversy in the past and reproductive health apps have faced increased scrutiny following changes to abortion regulations.
Natural Cycles had to submit clinical evaluations and comply with cybersecurity requirements for data privacy for this Apple Watch integration. It has also received clearance from European regulators and is registered for use in Australia.
Using temperature data from wearables can help eliminate user error and provide more consistent data, but it still requires users to use the app correctly to avoid unwanted pregnancies.
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