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Token Factory★ 3rd Place
PB&J
Predicates, Building, and Journey — navigating 510(k) submissions
About this project
An agent to evaluate potential predicates, generate an eSTAR-ready 510(k) application, and pre-empt potential FDA inquiries to save time and cost during medical-device development. Submitted to the NextGen BioAgents Hackathon (Nucleate NY × Nebius, Jun 2026).
Technologies
biohack
bioagents
hackathon
regulatory