AI devices with FDA product code PTA — Genetic Variant Detection And Health Risk Assessment System

Product code PTA (“Genetic Variant Detection And Health Risk Assessment System” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the Immunology panel (1). The most recent decision was 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia on April 6, 2017.