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Constat
Source-linked FDA AI medical-device evidence search across 510(k), MAUDE, recalls and reimbursement
0Visit Constat
https://constat.dev
About Constat
Constat is a search and monitoring layer over FDA AI/ML medical-device evidence, built for the regulatory, quality, clinical-evidence and market-access teams who currently assemble this picture by hand across separate government databases. It unifies the device lifecycle into one corpus: 510(k) summaries and predicate chains on the clearance side, MAUDE adverse events, recalls, warning letters and Form 483s on the postmarket side, and documented reimbursement pathways on the payment side. The published scale is specific rather than vague — 1,491 devices parsed for the Precedent module, 1,499 devices snapshotted with 8,558 signals for Postmarket, and 40 pathways traced for Reimbursement. Every result is source-linked back to the underlying FDA or CMS record, which is the property that makes it usable in a submission rather than only in exploratory work. The Precedent module answers the 'devices like mine' question that drives predicate selection; Postmarket surfaces per-device drift signals over time. Constat also ships an MCP server and AI-workflow surface, so an agent can query the corpus directly. Alongside self-serve search it sells bounded services: a one-time evidence assessment and a configured monthly monitoring brief.
Key Features
Constat Pros & Cons
✅ Pros
- +Source-linking is what makes the output usable in a regulatory submission rather than only for orientation
- +Joining clearance, postmarket and payment in one corpus removes a genuinely painful manual cross-reference
- +Published corpus counts are concrete and checkable rather than marketing scale claims
- +MCP support means the data is reachable from an agent workflow, not just a web UI
- +Free search entry point lets you assess coverage before buying a service engagement
⚠️ Cons
- −The paid offerings are consulting-shaped, so cost scales with scope rather than seats
- −$5,000 minimum for an evidence assessment is a committee decision, not a card swipe
- −Coverage is US FDA and CMS only — no EU MDR or other jurisdictions described
- −Useful to a narrow audience: this is not a general-purpose research tool
Who Is Constat Best For?
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