What category of product is Burna AI?

Drug safety technology, specifically AI for pharmacovigilance and oncology adverse event management. Burna AI is a clinical workflow and safety data quality tool, not a SaMD (software as a medical device) and not a diagnostic device. It does not prescribe dose modifications, does not assess tumor response (RECIST), and does not replace clinician judgment. Comparable category framing: a real-time, citation-bound substrate for the oncology safety data layer, applied across the full drug lifecycle from Phase 1 through decades of postmarket surveillance.