Natural Cycles, an FDA cleared birth control app in the United States and CE marked birth control app in Europe, has submitted a 510(k) Premarket Notification to the U.S. Food and Drug Administration (FDA).

The purpose of the notification is to revise the labelling to expand the types of third-party thermometers, which include wearables already on the market, that can be used with its app.

The Natural Cycles app, which received FDA clearance to be marketed as digital contraception in August of 2018, is powered by an algorithm that is able to identify a woman’s daily fertility status based on her basal body temperature and other menstrual data. Currently, users use a standard basal thermometer to take their daily temperature and input that temperature manually into the app.

New software has been developed and added to the Natural Cycles application that converts temperature data received from wearable devices that collect biometric temperature data to a format that can be interpreted by the Natural Cycles algorithm. This will remove the manual steps of measuring orally and entering temperature data for those users who wear an integrated device.

Natural Cycles co-founder and CEO Elina Berglund Scherwitzl said: “For years we’ve been looking to create a more seamless measuring experience for our users, and we were thrilled with the results from using our new software with temperature data from popular wearables. We know our users love having a hormone-free birth control option and we are excited to give them additional measuring options that many already have given a large number of our users own a wearable device.”