The Food and Drug Administration (FDA) has granted 510(k) clearance to Ava Fertility Tracker (Ava Science) as the first wearable, machine learning device to aid women in ovulation prediction and facilitation of conception.

The Ava Fertility Tracker is a fertility tracking sensor bracelet with an accompanying app designed to detect a woman’s most fertile days by recording their physiological parameters (eg, skin temperature, resting pulse rate, heart rate variability ratio, perfusion, breathing rate). The bracelet also has a built-in accelerometer to track movement as well as sleep quantity and quality. 

The clearance was supported by data from multiple performance tests, including a prospective clinical trial, which showed that the Ava Fertility Tracker accurately predicted the day of ovulation as well as urinary luteinizing hormone tests. Moreover, the Ava Fertility Tracker was able to detect greater post-ovulatory temperature shifts compared with other available temperature-based ovulation detection products.

The Company notes that the Ava Fertility Tracker is not intended for use by women taking hormonal birth control, or in women with irregular cycles that vary widely in length. The device has also not been designed nor tested for pregnancy prevention.

“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. “For example, LH tests only provide around 24 hours advance warning of ovulation, even though a woman is most fertile the 3 days preceding ovulation. Ava allows users to take advantage of more of the fertile window.”

The Ava basic plan retails for $259 and includes the Ava bracelet, in-app cycle fertility and pregnancy tracking, and membership in Ava’s online community.

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Ava announces FDA clearance for Ava Fertility Tracker. [press release]. Zurich, Switzerland: Ava Science Inc.; February 9, 2021.