The Zurich-based MedTech firm Ava has achieved a milestone in the USA. Its bracelet that aims to support women in their efforts to conceive has now been approved for the US market by the US FDA. According to a press release issued by Ava, its bracelet is the first wearable device that determines fertile days in women to have ever been cleared for use in the USA by the FDA.
The Ava bracelet is worn at night. Alongside temperature, it measures eight other physiological parameters such as breathing and heart rate. As a result, algorithms are able to calculate fertile days in real time.
According to information from the company itself, Ava submitted the results from several functionality tests and clinical trials to gain FDA clearance. These findings have shown that the bracelet is able to determine fertile days in women just as effectively and reliably as urine tests that measure luteinizing hormone (LH) levels. The bracelet additionally detected “significantly more post-ovulatory temperature shifts than other publicly available temperature-based ovulation detection products”.
Maureen Cronin, Chief Medical Officer at Ava, also highlighted in the press release that the Ava bracelet is just as reliable as other available products. However, she explains that wearing the fertility tracking bracelet is far less invasive than repeatedly testing urine samples.
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