AIFDA Intel

What it solves

FDA publishes AI device data across six separate databases — 510(k) clearances, De Novo decisions, MAUDE adverse events, warning letters, guidance documents, and predicate chains. It's scattered, unstructured, and buried inside 50,000+ non-AI devices. Regulatory teams and investors waste hours manually searching and filtering.

What it is

AIFDA Intel is the only platform focused exclusively on AI and ML-enabled medical devices. It aggregates, structures, and monitors FDA public data — filtered to AI devices only — and surfaces it through a subscription dashboard updated daily.

Built for

• — Regulatory affairs leads at AI medical device startups
• — Regulatory consultants serving AI device clients
• — Medtech investors tracking the AI device landscape
• — BD and strategy teams at large device companies

What's included

Other products from Lumenthis Labs