Regiome connects your AI agents to FDA drugs and devices, PubMed, ClinicalTrials.gov, NIH and 25+ authoritative sources — normalized, cross-referenced, and cited. The official-source data layer for pharma, medical-device, and clinical-research teams. One connector. Every source. Agent-ready.
For the teams that live in regulatory data — hours of portal work compressed into a single question.
Hunt 510(k) predicates, monitor PMA approvals, pull enforcement reports, and watch new device classifications — without leaving the chat.
Surface MAUDE adverse events on your devices and competitors, track recalls by product code, and feed signal-detection workflows.
Build literature appendices for EU MDR/IVDR clinical evaluations. Pull PubMed, ClinicalTrials.gov, and equivalent-device evidence in minutes.
Map indications to ICD-10 and LOINC, look up gene targets and ClinVar variants, and pull HPO terms for diagnostic device design.
Query CMS coverage decisions, look up physician fee schedules, and map procedures to provider taxonomies for go-to-market planning.
Track competitor 510(k)s, watch new entrants by product code, monitor recall trajectories, and read drug labels for combo products.
Regiome speaks directly to the official endpoints. No screen-scraping, no stale PDFs — the same data the regulators and the NIH publish, normalized and cross-walked.
510(k), PMA, classifications, recalls, adverse events, enforcement, UDI.
22 toolsLabels, NDC directory, FAERS, recalls, shortages, Orange Book, CRLs.
18 tools30M+ citations with full-text retrieval and citation graph traversal.
7 tools500K+ studies with status, phase, intervention, and outcomes filters.
3 toolsStructured product labeling for drugs and combination products.
3 toolsWONDER, vehss, open datasets — disease surveillance and mortality data.
5 toolsFunded projects, gene datasets, ClinVar variants, EVS concepts.
10 toolsNormalized drug naming, class hierarchies, related concepts.
5 toolsICD-10-CM, LOINC, HPO, UCUM, MeSH, UMLS — interoperability backbone.
9 tools2M+ U.S. healthcare providers with NPI, specialty, location.
2 toolsCoverage decisions, physician fee schedule, provider enrollment.
4 toolsPreventive recommendations, consumer drug and lab references.
5 toolsYou ask. The model picks the right tool. You get a sourced answer back.
Type the question the way you'd ask a colleague. No API keys, no query syntax, no NDC numbers needed.
The model selects from 150+ tools — searching, resolving codes, joining cross-references where it needs to.
Every fact carries the source. Export to a table, drop into a CER, or hand off as a Word doc.
Four questions, the way teams already ask them. Each runs in under a minute.
Browse what's connected. New tools ship as the underlying data sources expose them.
One connector reaches every FDA, NIH, CDC, CMS, and NLM endpoint.
Full FDA regulatory depth — 510(k), PMA, MAUDE, FAERS, Orange Book, labels.
Every fact tags its canonical source — K-numbers, NCT IDs, PMIDs — so you can verify.
Queries hit the official endpoints — what the agencies publish is what you get.
https://mcp.regiome.io plus an API key. Add it to Claude or ChatGPT as a custom connector and you're querying in minutes. See the connect steps.Add Regiome to Claude or ChatGPT as a custom connector with your endpoint and key — no install, no scraping, no glue code.
https://mcp.regiome.io
Tell us your team and use case — we provision your endpoint and API key.
In Claude or ChatGPT: Settings → Connectors → Add custom connector, paste your Regiome URL.
Add your key once, then ask in plain English. Cited answers come back in seconds.