www.fdanews.com/articles/196223-mfb-fertility-earns-fda-clearance-for-ovulation-test
MFB Fertility Earns FDA Clearance for Ovulation Test
March 12, 2020
The FDA granted 510(k) clearance to MFB Fertility’s Proov, a test taken at home to confirm ovulation.
The diagnostic strips test or the presence of PdG, a urine metabolite of progesterone, a hormone released by a woman’s ovary after ovulation.
MFB said that it plans to launch a Proov companion smartphone app later this year, which will help users collect data.