Is Burna AI FDA-approved?

Burna AI is not FDA-approved. Burna AI is eligible for the FDA Center for Drug Evaluation and Research (CDER) Emerging Drug Safety Technology Program (EDSTP); the application is planned for June to July 2026. EDSTP is the FDA pathway for collaborative review of emerging drug safety technology, the program's named scope. The platform is a clinical workflow tool, not a SaMD device, so the 510(k), De Novo, and PMA pathways are not applicable.