The FDA has greenlit digital birth control app Natural Cycles to integrate third-party thermometers—including consumer wearables into its app to help pinpoint a user's fertility status.  

Body temperature has been a component of Natural Cycles' calculations since the app hit the market. Specifically, the startup developed an algorithm that uses a women's basal body temperature and other menstrual data to calculate fertility status.

Previously users were required to manually take their temperature and add it to the app. However, thanks to this FDA revision, Natural Cycles can use its new software to integrate wearable data including a user's temperature and heart rate into the fertility algorithm.

The Swedish company announced that it submitted an FDA premarket notification for third-party thermometer integration back in October.

WHY IT MATTERS

When it comes to femtech, the market is large. A Frost & Sullivan study found that the global femtech market is expected to reach $1.15 billion by 2015. Fertility is a large piece of that market. According to the CDC, approximately 64% of women between the ages of 15 to 49 are currently using contraception.

Today there are several virtual care companies that prescribe traditional contraception. However, in 2018 Natural Cycles landed a de novo FDA clearance for its digital birth control. Since then Clue has also had the FDA nod.

THE LARGER TREND

Cofounded by Dr. Elina Berglund, a former CERN physicist, and her husband Dr Raoul Scherwitzl, Natural Cycles got its start in the European market, scoring a CE certification in 2017. Later it came to the Us after gaining FDA clearance.

But it hasn't been all smooth sailing for the company. In 2018 the UK’s Advertising Standards Authority (ASA) banned Natural Cycle's  Facebook ad claiming that its description as a "highly accurate contraceptive app" and a "clinically tested alternative to birth control methods" was misleading after receiving three complaints about the paid-for post.

The app also had some controversy after Södersjukhuset hospital in Stockholm, Sweden reported the system to Sweden’s Medical Products Agency (MPA) after it found that 37 women among 668 had experienced an unplanned pregnancy while using the app. The company contested the claims against its effectiveness, stating that these cases translated to a roughly 95% success rate—which exceeds the rate advertised by the company.