FDA Clears Ava’s Wearable Women’s Fertility Tracker

The FDA has granted 510(k) marketing clearance for Ava’s Fertility Tracker, a wearable device that links to a smartphone app to help women track ovulation.

In clinical trials, the bracelet device predicted the day of ovulation in a woman’s cycle just as well as luteinizing-hormone (LH) urinary tests and detected significantly more post-ovulatory temperature shifts than other ovulation detection products, the Zurich, Switzerland-based company said.

Ava noted that its device, which previously received European clearance, is designed to help women facilitate conception, not to serve as a contraceptive.