Pure Cycles has acquired FDA approval to make use of Apple Watch temperature information

The US Meals and Drug Administration has authorised the Apple Watch to be used with Pure Cycles, a digital contraception app. This implies Pure Cycles customers who personal an Apple Watch Sequence 8, 9, Extremely, or Extremely 2 can now import their temperature information from the watch as an alternative of manually measuring their basal physique temperature each morning. This marks Pure Cycles’ second wearable integration to be authorised by the FDA, the primary being the Oura Ring.

Apple Watch integration is a giant deal, on condition that it captured almost 30 % of the worldwide smartwatch market in 2022, which can be the yr Apple launched temperature sensors within the Sequence 8. Though it isn’t the primary smartwatch to take action Nevertheless, Apple’s take was distinctive in that it included two temperature sensors. One is situated slightly below the display, whereas the opposite is situated nearer to the pores and skin. The primary is meant to take ambient temperature readings to assist get rid of environmental bias. It was additionally the sensors that enabled Apple to incorporate superior cycle monitoring with retrospective ovulation estimates.

The Pure Cycles app requires individuals to enter each day temperature information — from a basal physique thermometer, which is free with a subscription if you do not have a appropriate wearable system — which is then fed into an algorithm meant to tell customers of their fertility standing. It’s presently the one digital contraception app that has been authorised by the Meals and Drug Administration (FDA) and is classed as a Class II medical system. Class II gadgets are these outlined as having average to excessive danger to the consumer and embody issues like blood stress cuffs, contact lenses, and smartwatch ECG options used to detect atrial fibrillation. Well-liked menstrual monitoring app Clue additionally acquired FDA approval as a contraceptive in 2021 however has since paused the characteristic.

In an announcement, Pure Cycles co-founder and CEO Elena Berglund Scherwitzl stated the corporate has acquired quite a few requests from customers to combine Apple Watch integration as soon as the Sequence 8 launches with the brand new temperature sensors. Older Apple Watch fashions haven’t got temperature sensors, and SE fashions do not; Solely Sequence 8, 9, and Extremely fashions are appropriate with this characteristic.

Utilizing wearable temperature information to trace reproductive well being is a rising development. Pure Cycles first pursued “wearable contraception” in 2020 earlier than gaining FDA approval for the expertise in 2021. It acquired approval for its Oura Ring integration final yr, and earlier this yr, It partnered with Samsung to adapt its algorithm for superior cycle monitoring for the corporate’s Galaxy Watch 5 and 6 sequence smartwatches. (Nevertheless, Galaxy Watches should not appropriate with Pure Cycles’ contraception options.)

Nevertheless, pure cycles should not with out controversy. The Meals and Drug Administration initially granted the app approval for its digital contraception characteristic in 2018, however the choice acquired some backlash after the app was linked to 37 undesirable pregnancies at one hospital in Sweden. Moreover, reproductive well being apps have acquired elevated scrutiny in the US after the Supreme Court docket overturned them Roe v. Wade In 2022.

Pure Cycles says that for this integration, it needed to submit scientific evaluations to the FDA by means of the company’s 510(okay) assessment course of, in addition to show that the app complies with cybersecurity necessities for information privateness. Along with the FDA, Pure Cycles says its Apple Watch integration has additionally acquired approval from European regulatory our bodies and can be registered to be used in Australia.

Nevertheless, acquiring regulatory approval doesn’t imply that these strategies are foolproof. The upside to utilizing temperature information from wearable gadgets is that it might get rid of some consumer error by including one other layer of automation, in addition to offering extra constant information. Nevertheless, it nonetheless requires shoppers to decide to utilizing the app accurately, and consumer error could result in undesirable pregnancies.