bots.st/constat-mcp-fda-device-evidence-lifecycle
Constat MCP — FDA Device Evidence Lifecycle
FDA device evidence and reimbursement pathways
2238 ms
answered our call
- State
- Answered
- Protocol
- MCP 2025-06-18
- Tools listed
- 14
- Answered
- 3 of the last 3 calls
How to reach it
- MCP, HTTP
https://constat.dev/api/mcp
What it can do
| Tool | What it says it does |
|---|---|
cohort_postmarket_stats | Postmarket presence rates across the snapshotted AI/ML device cohort (optionally by panel): share with any recall in 24 months, with a rising MAUDE trend, with any drift signal, with a warning-letter match — every rate with its denominator inline, never pooled across devices. |
device_evidence_lookup | Look up the structured premarket evidence FDA accepted for a specific AI/ML-enabled device by 510(k) number (e.g. K252148). Returns parsed summary fields — validation study design, sample sizes, endpoints, reported performance, predicate chain, PCCP — each with a verbatim source quote and page… |
device_postmarket_lookup | Post-clearance intelligence for one AI/ML device by 510(k) number: its product code's recalls, MAUDE adverse-event level and trend, warning-letter and 483 matches for the applicant, plus per-device drift signals (adverse-event inflection, re-clearances of the same device line, software-recall… |
device_risk_lookup | Review a medical-device category's public FDA signals by three-letter product code (e.g. FRN = infusion pump). Returns recalls, MAUDE adverse-event trend, warning-letter matches, a normalized category signal, its driver contributions, and interpretation limits. It does not predict enforcement… |
evidence_cohort_stats | Reporting-rate stats across the parsed AI/ML corpus (optionally by panel). Each rate is a presence figure with its denominator — 'reported in X of Y audited devices' — never a pooled performance value. Excludes not-yet-parsed devices from every denominator and discloses the parse queue separately… |
evidence_search | Find AI/ML device clearances by filter — product code, panel, applicant, and whether the submission reported clinical data, any sensitivity metric, or a PCCP. Answers 'what evidence did FDA accept for devices like mine'. Returns bounded discovery summaries; call device_evidence_lookup with a… |
firm_compliance_history | Build a recent, source-bounded FDA public-record timeline for a device firm: matched recalls, warning letters, and Form 483 citations where exact FEI numbers are available. Product codes are discovered from Constat's AI/ML-device corpus or may be supplied explicitly. Returns attribution and… |
postmarket_search | Find AI/ML devices by postmarket criteria — product code, panel, applicant, whether any drift signal exists, minimum recalls in 24 months, or a rising MAUDE trend. Returns per-device postmarket summaries with drift-signal counts. |
predicate_chain | Trace the predicate ancestry of a 510(k) device, with each cited predicate's age (how many years old the predicate was when the child cleared). Reveals how AI/ML devices chain to older predicates. |
reimbursement_lookup | Trace the clearance-to-payment pathway for an AI/ML device by FDA clearance number (K/DEN, e.g. DEN170073) OR bare CPT code (e.g. 75580). Returns every payment mechanism (NTAP add-on, Category I/III CPT + CMS rate, HCPCS, MAC LCD) with amounts, effective dates, and source links, plus any… |
reimbursement_search | Find AI/ML device payment pathways by mechanism — e.g. 'devices that got NTAP', 'devices paid under a Category I CPT code', 'pathways with a known CMS dollar rate'. Filters: mechanism, CPT category, NTAP status, applicant. Returns pathways with amounts, effective dates, and sources. Use… |
reimbursement_stats | Distribution of payment mechanisms across the AI/ML reimbursement corpus — pathway and distinct-device counts per mechanism (NTAP, Cat I, Cat III/APC, …) with the min/median/max dollar amounts for each. Deliberately never a single pooled 'reimbursement rate': NTAP add-on amounts and CMS rates are… |
vehicle_risk_lookup | Look up NHTSA safety history for a vehicle by make, model, and model year. Returns recall campaigns and complaint statistics (crashes, fires, injuries, top components). |
watchlist_diff | Return machine-generated FDA public-record changes detected for monitored product codes since a caller-supplied date, plus each code's latest category snapshot and postmarket coverage. Defaults to Constat Radar's five-code watchlist and the last seven days. Analyst verdict text and internal review… |
In its maker's words
FDA and CMS evidence for AI medical devices: 510(k), postmarket, reimbursement, and compliance.
- Website
- constat.dev/connect
- Source
- github.com/healthai-hq/fda-risk-radar
- Publisher
- healthai.com (2 listings in the registry)
- Listed from
- the official MCP Registry as
com.healthai/radar - Version
- 0.5.3, updated 30 Jul 2026
- Kinds of work
- Law, tax and government, Search and research, Finance and markets
The domain it lives on
- constat.dev
- registered 11 Jul 2026 (4 months ago), at CloudFlare, Inc., its name does not resolve now
From our own crawl of domain names: registry records and the home page as our crawler last saw it.
Every call we made
| When | What happened | Time |
|---|---|---|
| Answered | 2238 ms | |
| Answered | 2308 ms | |
| Answered | 761 ms |
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