Natural Cycles gets FDA clearance to use Apple Watch temperature data for birth control

The FDA has cleared the Apple Watch for usage with Natural Cycles, a integer commencement power app. This means Natural Cycles users who ain an Apple Watch Series 8, 9, Ultra, oregon Ultra 2 tin present import their somesthesia information from the ticker alternatively of manually taking their basal assemblage somesthesia each morning. This marks Natural Cycles’ 2nd FDA-cleared wearable integration, with the archetypal being the Oura Ring.

Apple Watch integration is simply a large deal, fixed that it held astir 30 percent of the planetary smartwatch market successful 2022, which is besides the twelvemonth Apple introduced somesthesia sensors connected the Series 8. While it’s acold from the archetypal smartwatch to bash so, Apple’s instrumentality was unsocial successful that it incorporated 2 somesthesia sensors. One was located conscionable underneath the display, portion the different was located person to the skin. The archetypal is meant to instrumentality ambient somesthesia readings to assistance destruct biology bias. The sensors were besides what enabled Apple to see precocious rhythm tracking with retrospective ovulation estimates.

The Natural Cycles app requires radical to input regular somesthesia information — from a basal assemblage somesthesia thermometer, which is escaped with a subscription if you don’t person a compatible wearable — which is past fed into an algorithm that purports to pass users of their fertility status. It’s presently the lone FDA-cleared integer commencement power app successful usage and designated arsenic a Class II aesculapian device. Class II devices are those defined arsenic having a mean to precocious hazard to the idiosyncratic and see things similar humor unit cuffs, interaction lenses, and smartwatch EKG features utilized to observe atrial fibrillation. Popular play tracking app Clue had besides received FDA clearance arsenic a contraceptive successful 2021 but has since paused that feature.

In a statement, Natural Cycles co-founder and CEO Elina Berglund Scherwitzl said the institution received galore requests from users to incorporated an Apple Watch integration erstwhile the Series 8 launched with the caller somesthesia sensors. Older models of the Apple Watch bash not see somesthesia sensors, nor bash the SE models; lone the Series 8 and 9 and the Ultra models are compatible with the feature.

The usage of wearable somesthesia information for reproductive wellness tracking is simply a rising trend. Natural Cycles archetypal pursued “wearable commencement control” back successful 2020 earlier receiving FDA clearance for this exertion successful 2021. It gained clearance for Oura Ring integration past year and, earlier this year, partnered with Samsung to accommodate its algorithm for precocious Cycle Tracking for the company’s Galaxy Watch 5 and 6 bid smartwatches. (The Galaxy Watches, however, are not compatible with Natural Cycles’ commencement power features.)

That said, Natural Cycles is not without controversy. The FDA initially granted the app clearance for its integer commencement power diagnostic successful 2018, but the determination received immoderate backlash aft the app was linked to 37 unwanted pregnancies astatine a azygous infirmary successful Sweden. Furthermore, reproductive wellness apps person received accrued scrutiny successful the US pursuing the Supreme Court’s reversal of Roe v. Wade successful 2022.

Natural Cycles says for this integration, it had to taxable objective evaluations to the FDA via the agency’s 510(k) reappraisal process, arsenic good arsenic impervious that the app complies with cybersecurity requirements for information privacy. In summation to the FDA, Natural Cycles says its Apple Watch integration has besides received clearance from European regulators and has besides been registered for usage successful Australia.

Even so, receiving regulatory clearance doesn’t mean these methods are foolproof. The upside to utilizing somesthesia information from wearables is that it whitethorn destruct immoderate idiosyncratic mistake by adding different furniture of automation, arsenic good arsenic providing much accordant data. However, it inactive requires consumers to adhere to utilizing the app correctly, and idiosyncratic mistake tin inactive effect successful unwanted pregnancies.