The FDA has cleared 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 a substitute of manually taking their basal physique temperature every morning. This marks Pure Cycles’ second FDA-cleared wearable integration, with the primary being the Oura Ring.
Apple Watch integration is an enormous deal, on condition that it held roughly 30 p.c of the worldwide smartwatch market in 2022, which can be the yr Apple launched temperature sensors on the Sequence 8. Whereas it’s removed from the primary smartwatch to take action, Apple’s take was distinctive in that it integrated two temperature sensors. One was positioned simply beneath the show, whereas the opposite was positioned nearer to the pores and skin. The primary is supposed to take ambient temperature readings to assist eradicate environmental bias. The sensors had been additionally what enabled Apple to incorporate superior cycle monitoring with retrospective ovulation estimates.
The Pure Cycles app requires folks to enter every day temperature information — from a basal physique temperature thermometer, which is free with a subscription in case you don’t have a suitable wearable — which is then fed into an algorithm that purports to tell customers of their fertility standing. It’s presently the one FDA-cleared digital contraception app in use and designated as a Class II medical system. Class II gadgets are these outlined as having a reasonable to excessive threat to the consumer and embody issues like blood stress cuffs, contact lenses, and smartwatch EKG options used to detect atrial fibrillation. Well-liked interval monitoring app Clue had additionally acquired FDA clearance as a contraceptive in 2021 however has since paused that characteristic.
In a press release, Pure Cycles co-founder and CEO Elina Berglund Scherwitzl stated the corporate acquired quite a few requests from customers to include an Apple Watch integration as soon as the Sequence 8 launched with the brand new temperature sensors. Older fashions of the Apple Watch don’t embody temperature sensors, nor do the SE fashions; solely the Sequence 8 and 9 and the Extremely fashions are suitable with the characteristic.
Using wearable temperature information for reproductive well being monitoring is a rising development. Pure Cycles first pursued “wearable contraception” again in 2020 earlier than receiving FDA clearance for this know-how in 2021. It gained clearance for Oura Ring integration final yr and, earlier this yr, partnered with Samsung to adapt its algorithm for superior Cycle Monitoring for the corporate’s Galaxy Watch 5 and 6 collection smartwatches. (The Galaxy Watches, nevertheless, will not be suitable with Pure Cycles’ contraception options.)
That stated, Pure Cycles shouldn’t be with out controversy. The FDA initially granted the app clearance for its digital contraception characteristic in 2018, however the resolution acquired some backlash after the app was linked to 37 undesirable pregnancies at a single hospital in Sweden. Moreover, reproductive well being apps have acquired elevated scrutiny within the US following the Supreme Courtroom’s reversal of Roe v. Wade in 2022.
Pure Cycles says for this integration, it needed to submit scientific evaluations to the FDA through the company’s 510(okay) overview course of, in addition to proof that the app complies with cybersecurity necessities for information privateness. Along with the FDA, Pure Cycles says its Apple Watch integration has additionally acquired clearance from European regulators and has additionally been registered to be used in Australia.
Even so, receiving regulatory clearance doesn’t imply these strategies are foolproof. The upside to utilizing temperature information from wearables is that it might eradicate some consumer error by including one other layer of automation, in addition to offering extra constant information. Nevertheless, it nonetheless requires shoppers to stick to utilizing the app accurately, and consumer error can nonetheless lead to undesirable pregnancies.
