Cruxi

Cruxi is an AI-powered regulatory submission platform for medical device teams that automates FDA 510(k), De Novo, PMA, IDE and global filings by using AI-driven device classification, predicate finding, eSTAR drafting, automated RTA/compliance checks, evidence planning and package export combined with human-in-the-loop review; its models are trained on FDA guidance and regulatory databases with traceable citations (zero-hallucination claims), continuous regulatory updates, and enterprise-grade security to help teams move faster, reduce refusal-to-accept risks, and produce reviewer-ready, submission-quality dossiers.