Swedish CE-certified birth control app, Natural Cycles has announced that it has submitted a 510(k) Premarket Notification to the U.S. Food and Drug Administration (FDA).
The Natural Cycles app, is the first and only FDA cleared birth control app in the US.
WHY IT MATTERS
The purpose of the notification is to revise the labeling to expand the third-party thermometers, which include wearables already on the market, which can be used with its app.
The app 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 users who wear an integrated device.
THE LARGER CONTEXT
Last year, Natural Cycles took part in a study that analysed key characteristics of over 600,000 menstrual cycles and data from nearly 125,000 women from Sweden, the UK and the US, to highlight the benefits of understanding their own cycle characteristics rather than relying on a standardised cycle.
The app received FDA clearance to be marketed as the first digital contraception in August of 2018.
The year before, it raised $30 million in a round led by EQT Ventures, bringing the company's total funding to around $38 million.
ON THE RECORD
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.”