FDA and CMS evidence for AI medical devices: 510(k), postmarket, reimbursement, and compliance.
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com.healthai/radar is an MCP server that FDA and CMS evidence for AI medical devices: 510(k), postmarket, reimbursement, and compliance. Its tool list has not been published yet, requires no API key, and scores 33/100 on MCPpedia's security, maintenance and efficiency rubric.
Config is the same across clients — only the file and path differ.
{
"mcpServers": {
"com-healthai-radar": {
"command": "<see-readme>",
"args": []
}
}
}Are you the author?
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The MCP server behind Constat — FDA & NHTSA regulatory-risk intelligence for AI agents, over the Model Context Protocol. Live public regulatory data — recalls, adverse events, warning letters, 510(k) premarket evidence, postmarket drift signals, reimbursement pathways, and vehicle safety. Decision support, not regulatory advice.
No automated test available for this server. Check the GitHub README for setup instructions.
Five weighted categories — click any category to see the underlying evidence.
No known CVEs.
No package registry to scan.
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The MCP server behind Constat — FDA & NHTSA regulatory-risk intelligence for AI agents, over the Model Context Protocol. Live public regulatory data — recalls, adverse events, warning letters, 510(k) premarket evidence, postmarket drift signals, reimbursement pathways, and vehicle safety. Decision support, not regulatory advice.
https://constat.dev/api/mcp (legacy https://radar.healthai.com/api/mcp still serves)X-API-Key header enables the separately
assigned metered allowance. Tool calls have documented work-unit costs.com.healthai/radar (official MCP registry)The evidence corpus and tool logic run hosted at the endpoint above. This repo
also ships server.mjs, a zero-dependency stdio bridge to that endpoint, so
stdio-only MCP clients can use the server like any local one:
node server.mjs # stdio MCP server, bridges to constat.dev/api/mcp
// e.g. in an MCP client config
{ "mcpServers": { "constat": { "command": "node", "args": ["/path/to/server.mjs"] } } }
docker build -t constat-mcp . && docker run -i constat-mcp # same, containerized
| Tool | What it does |
|---|---|
device_risk_lookup | FDA compliance risk for a device category by 3-letter product code — recalls, MAUDE trend, warning-letter matches, composite score |
firm_compliance_history | Source-bounded FDA public-record timeline for a device firm — recalls, warning letters, 483s, clearances |
watchlist_diff | Machine-detected FDA public-record changes for monitored product codes since a given date |
device_evidence_lookup | Parsed 510(k) premarket evidence for an AI/ML device, each field with a verbatim source quote + page |
evidence_search | Find AI/ML clearances by product code, panel, applicant, clinical data, sensitivity metric, or PCCP |
predicate_chain | Trace a device's predicate ancestry with each predicate's age at clearance |
evidence_cohort_stats | Reporting-rate stats across the parsed AI/ML corpus — presence figures with denominators |
device_postmarket_lookup | Post-clearance intelligence for one device — recalls, MAUDE trend, letter/483 matches, drift signals |
postmarket_search | Find devices by postmarket criteria — drift signals, recalls in 24mo, rising MAUDE trend |
cohort_postmarket_stats | Postmarket presence rates across the AI/ML cohort, each with its denominator |
reimbursement_lookup | Clearance-to-payment pathway by K/DEN or CPT code — NTAP, Cat I/III, CMS rates, HCPCS, LCDs |
reimbursement_search | Find payment pathways by mechanism, CPT category, NTAP status, applicant |
reimbursement_stats | Mechanism distribution across the reimbursement corpus with dollar ranges |
vehicle_risk_lookup | NHTSA safety history by make/model/year — recall campaigns and complaint stats |
curl -s https://constat.dev/api/mcp \
-H 'content-type: application/json' \
-H 'accept: application/json, text/event-stream' \
-d '{"jsonrpc":"2.0","id":1,"method":"tools/call",
"params":{"name":"device_risk_lookup","arguments":{"product_code":"FRN"}}}'
List tools with {"method":"tools/list"}. Note the Accept header must include
text/event-stream (streamable-HTTP requirement).
Each of the 14 tools declares an output schema. Tool calls return stru