Ava becomes the first and only FDA-cleared fertility tracking wearable

Ava has received FDA clearance of its 510(k) application for the Ava Fertility Tracker, making it the first and only FDA-cleared fertility tracking wearable. This major milestone comes after multiple performance tests that validated Ava’s comparability and superiority over traditional methods. 

Ava Fertility Tracker, a fertility tracking sensor bracelet and accompanying app, is already the first and only wearable, machine learning device to aid women in ovulation prediction and facilitation of conception. Launched in the US in 2016, the Ava bracelet is now sold in 36 countries and has helped close to 40,000 women become pregnant. The company has offices in Zurich, San Francisco, Belgrade and Makati.

The startup’s success is attributed to its unique approach and superiority in the fertility tracking market. For instance, as explained by Maureen Cronin, Ava’s Chief Medical device, temperature-based methods of fertility tracking only identify ovulation when a woman is no longer fertile and often require peeing on multiple sticks throughout the month. These methods also require that a woman wakes up at the same time every morning to take her temperature. 

Worn only during sleep, the Ava fertility tracker bracelet, tracks multiple physiological parameters including pulse rate, breathing rate, and skin temperature much more conveniently in non-invasive manner. The device detects the five most fertile days of a woman’s cycle in real-time with 90% accuracy, while also delivering personalised insights about reproductive health and pregnancy. “LH tests only provide around 24 hours advance warning of ovulation, even though a woman is most fertile the three days preceding ovulation,” said Cornin.

The Ava device was successfully certified under the new European Device Regulation (MDR). Now, backed by the FDA clearance of its 510(k) application, Ava can also point to the efficacy of the Ava Fertility Tracker as comparable to time-trusted methods.

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

(press relase/RAN)