Ava, a Swiss company focused on women’s reproductive health, has received FDA clearance for its fertility tracker, making it the first and only FDA-cleared fertility tracking wearable.

A fertility tracking sensor bracelet and accompanying app, the tracker wearable uses machine learning to aid women in ovulation prediction and facilitation of conception. The device was certified under the European Device Regulation (MDR) and is now backed by the FDA 501(k) clearance.

To gain FDA clearance, Ava submitted multiple performance tests, including a prospective clinical trial demonstrating that the tracker accurately predicted the day of ovulation in a woman’s cycle just as well as urinary LH tests. The research also showed that the tracker detected significantly more post-ovulatory temperature shifts than other publicly available temperature-based ovulation detection products.

“The FDA clearance validates Ava’s efficacy as comparable or superior to standard products found in every pharmacy,” said Ava chief medical officer Maureen Cronin. “However, Ava offers significant advantages over other fertility tracking methods. Not only is Ava easier and less invasive than having to pee on multiple sticks throughout the month, we also detect more fertile days in a woman’s cycle, giving her more time and increased chances to conceive. For example, LH tests only provide around 24 hours advance warning of ovulation, even though a woman is most fertile the three days preceding ovulation. Ava allows users to take advantage of more of the fertile window.”

In addition, according to Cronin, temperature-based methods of fertility tracking only identify ovulation after the fact, when a woman is no longer fertile. And many temperature-based methods of fertility tracking require that a woman wake up at the same time every morning to take her temperature.

“As a wearable, Ava collects temperature data – jointly with various other physiological parameters – more conveniently,” said Cronin. “And because it measures temperature continuously throughout the night, our data showed that it is more sensitive to detecting post-ovulatory temperature shifts.”

The Ava bracelet is not intended to be used for contraception.

Ava is a digital health company with offices in Zurich, San Francisco, Belgrade and Makati. Its fertility tracking sensor bracelet detects the five most fertile days of a woman’s cycle in real time with 90% accuracy, while also delivering personalised insight about reproductive health and pregnancy.

Worn only during sleep, the bracelet tracks multiple physiological parameters including pulse rate, breathing rate and skin temperature.

Launched in the USA in 2016, the bracelet is now sold in 36 countries and has helped around 40,000 women become pregnant. Studies for the clinical use of Ava have been conducted in collaboration with academic partners around the world, including at the University Hospital of Zurich, Columbia University and Northwestern University’s Feinberg School of Medicine.