Diversatek Healthcare received FDA approval for its MiVu Mucosal Integrity Testing System, the first such device on the market.
MiVu was granted De Novo classification by the FDA for the safety and efficacy in obtaining measurements of electrical properties within esophageal tissue. According to Diversatek, it is “the only system available to clinicians that provides real-time data of mucosal integrity during routine endoscopy, indicating the existence or probability of gastroesophageal reflux disease (GERD) and other esophageal pathologies in just two minutes.”