With an eye toward helping women approaching menopause and their providers make decisions regarding care, the FDA has allowed the marketing of the PicoAMH Elisa diagnostic test, which measures the amount of anti-Müllerian hormone (AMH) in the blood. The test, from Webster, Texas-based Ansh Labs LLC, aims to help determine whether a woman is approaching menopause or is likely to have had her final menstrual period. To arrive at its favorable decision, the agency examined data for the PicoAMH Elisa test through de novo premarket review, a regulatory pathway for low-to-moderate risk devices of a new type. Read More
