Swiss wearable maker Ava today announced that it had received FDA clearance for its fertility tracking wearable. This is the first, and only FDA cleared fertility tracker, clinically proven as effective for LH tests in predicting ovulation.
The sensor band was successfully certified under the new European Device Regulation (MDR) and is now backed by the FDA clearance of its 501(k) application.
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Results from clinical trials showed 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 inferred that the tracker could detect significantly more post-ovulatory temperature shifts.
Although popular wearable brands such as the Apple Watch started offering cycle tracking starting with iOS 13 and watchOS 6, the Apple Watch Series 6 (latest Apple Watch) does not have the capabilities to track skin temperature.
Ava’s on-wrist tracker not only includes sensors for skin temperature but also captures other physiological data. Combining the data from Resting heart rate, HRV ratio, breathing rate, skin temperature, and perfusion can more accurately determine fertility days.
The Ava band is available starting at $259, and the AVA Plus offered at $299 provides a 12-month guarantee and offers a full refund.
The tracker is also available via Carrot Fertility, the leading global fertility benefits provider for employers. You can check with your employer if they offer fertility benefits and try out the wearable without paying the full costs.
Worn only during sleep, the Ava bracelet tracks multiple physiological parameters, including pulse rate, breathing rate, and skin temperature. Launched in the US in 2016, the Ava bracelet is now sold in 36 countries and has helped around 40,000 women become pregnant.
Ava was voted Best of Baby Tech at CES, named a Women’s Health “Editors’ Choice” product, and honored as a CB Insights Digital Health 150 company.