We’re proud to announce the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for Healgen Rapid Check® COVID-19/Flu A&B Antigen Test for over-the-counter (OTC) use. The FDA’s De Novo pathway is designed for medical devices that do not have legally marketed comparison device, and is a unique opportunity for development of a new device classification that can improve patient care and outcomes. Today, FDA granted marketing authorization for a COVID-19/flu test for use without a prescription. This is for use by individuals experiencing respiratory symptoms & uses a nasal swab sample to deliver at-home results for COVID-19 and flu. fda.gov/news-events/pr… https://www.fda.gov/news-events/press-announcements/da-authorizesmarketing-first-home-flu-and-covid-19-combination.test-outside-emergency-use