The Platform
Every feature is built on the same connected dataset — so a clearance, its predicate, its guidance context, and its enforcement history are never more than a click apart.
950+ FDA-cleared AI and ML devices, fully structured and tagged — including PCCP status. The static spreadsheet FDA publishes becomes a queryable database with every field that matters for regulatory strategy.
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Find which AI devices are being used as predicates, and how often. Turns the predicate graph into a strategy tool — find the fastest path to clearance for your indication.
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Track the De Novo decisions that create entirely new AI product codes. These define the regulatory categories your competitors — and you — will clear into for years.
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Every AI-related FDA guidance, draft, action plan, and discussion paper in one place — connected to the device-level data each one governs. Plain-English summaries included.
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See who dominates each AI indication. First-mover analysis, clearance velocity, and investor-grade charts turn public 510(k) summaries into a competitive map.
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Estimate your path to clearance from the histories of similar cleared devices. Build a defensible timeline grounded in what actually happened in your category.
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Watch FDA's enforcement posture on AI devices as it develops. Warning letters and enforcement actions are surfaced and tied to the products and indications they touch.
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Track adverse event reports for AI-enabled devices in MAUDE, connected to the cleared device records. Spot signal before it becomes an enforcement story.
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Get notified the moment something moves: a competitor clears, FDA publishes new guidance for your product code, or a PCCP is approved in your space. Real-time on Professional.
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Start your 14-day free trial on Professional. No credit card required.
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