What category of product is Burna AI?

Burna AI is adverse event software for clinical research and pharmacovigilance: it grades, attributes, codes and reports adverse events, from first-in-human trials through postmarket surveillance. It is designed as non-device clinical decision support. Every suggestion shows its basis, the source sentence, the CTCAE criterion and the attribution reasoning, so the clinician can review that basis independently before signing rather than rely on the suggestion. Burna AI has submitted a Q-Submission to FDA, and its application to the CDER Emerging Drug Safety Technology Program (EDSTP) is in progress. Whether a treatment works is the sponsor's question, not one Burna AI answers, and the platform makes no treatment or dosing recommendation.