Natural Cycles Submits Premarket Notification to the FDA for Wearable Birth Control

Natural Cycles, which claims to be the first and only FDA-cleared birth control app in the United...

Photo credit: Natural Cycles

Natural Cycles, which claims to be the first and only FDA-cleared birth control app in the United States and CE-marked birth control app in Europe, announced that the company has submitted a 510(k) Premarket Notification to the U.S. Food and Drug Administration (FDA).

Read more: Nuvo Awarded FDA Clearance for its Remote Pregnancy Monitoring System INVU

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

Up until now, many women would wake up in the morning, stick a thermometer in their mouth and enter their temperature into the Natural Cycles app. The new wearable app from Natural Cycles will change all that.

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 basal thermometer to take their daily temperature and input that temperature manually into the app, reports BusinessWire.

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.

“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,” said Natural Cycles co-founder and CEO Elina Berglund Scherwitzl. “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.”

Since Natural Cycles was launched in 2013 by physicists Elina Berglund and Raoul Scherwitzl, the company has garnered over 1.8 million registered users worldwide.

Read more: Femtech Startup Lady Technologies Introduces 2-in-1 Device that Combines Fertility Tracking with Pelvic Floor Exercising

While waiting for the FDA’s clearance on the 501(k)submission, Natural Cycles has released a beta launch that will allow select Natural Cycles users to sync temperature data collected when wearing certain wearable devices, including the Oura Ring. While in beta, measurement functionality will only be available to users who are not using the app for birth control. Since 25% of Natural Cycles users use the app outside of preventing pregnancy - including to plan pregnancy or to monitor their cycle - those in the beta will use it solely as a fertility tracker, the company said.

Sam Draper
October 21, 2020

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