Is Burna AI FDA approved or cleared?

Burna AI has submitted a Q-Submission to FDA, and its application to the CDER Emerging Drug Safety Technology Program (EDSTP) is in progress. Burna AI's position is that it is non-device clinical decision support rather than a device requiring approval or clearance: a clinician reviews and signs every grade, with the CTCAE criterion and the source line on screen to check the basis independently, one of the conditions section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act sets for software outside the device definition. EDSTP is the program in FDA's Center for Drug Evaluation and Research for discussing the use of AI and other emerging technologies in pharmacovigilance with industry and the vendors that support it. Its meetings are nonbinding on both FDA and the requester. AI suggests, clinicians decide.