Sentium Bio is the AI agent platform for regulatory submissions in biotech and medtech
Sentium Bio is the AI agent platform for regulatory submissions in biotech and medtech. Sentium brings submission evidence, predicate intelligence, dossier drafting, and decision history into one intelligent workspace - built for startups moving toward their first 510(k), so the team keeps momentum while Sentium tracks the regulatory strategy. Sentium's AI agents organize evidence, map predicates, draft and review dossier sections, surface gaps, and link every regulatory claim to its source - keeping a complete, traceable record of the reasoning behind each submission. From the first 510(k) to design controls, Q-Subs, testing strategy, and post-market evidence, Sentium grows with your company across every product line. For more information, visit sentium.bio