FDA Explorer
Search and link FDA records — product codes, classifications, guidance, and cleared devices — connected into one navigable map.
01 — Spark
Every device begins with a single idea.
A clear intended use, and the market it serves.
02 — Velocity
As product velocity builds, the evidence and rationale scatters.
Technical summaries, documents, and reports fragment across silos.
03 — Order
Sentium agents bring signal back into order.
Device history, documents, and evidence in one workspace — each claim traceable to its source.
04 — Research
Then researches predicates and submission strategy.
Making the path to a regulatory strategy more efficient.
05 — Momentum
Regulatory strategy that moves and grows with the product.
Letting product momentum build with regulatory strategy in mind — with Sentium Bio.
The platform
Built for builders preparing regulatory submissions.
Four agents that read your sources, hold the regulatory context, and keep the work moving — all backed by source documents. No guessing.
Product Understanding
Agents ingest your device documents and build a structured picture of intended use, design, and current state from the start.
Predicate Intelligence
Agents research the relevant product codes and predicate candidates, with the cleared-device evidence behind each one.
Submission Readiness
Agents draft and audit documents, match the IFU, and assemble source-linked 510(k) sections for human review.
Every output is grounded in your sources and FDA records, with the citation visible. People review and decide.
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