For pharma, medical device & clinical research

All the regulatory and medical data your team digs through, in one ask.

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.

Request access → See it in action
150+
Tools, ready to call
25+
Authoritative data sources
Live
Real-time FDA & CDC data
Rx + Dx
Full drug & device regulatory depth
Built for life-sciences teams

Less tab-juggling. More signal.

For the teams that live in regulatory data — hours of portal work compressed into a single question.

Regulatory Affairs

Hunt 510(k) predicates, monitor PMA approvals, pull enforcement reports, and watch new device classifications — without leaving the chat.

510(k)PMAClassificationsEnforcement

Post-Market Surveillance

Surface MAUDE adverse events on your devices and competitors, track recalls by product code, and feed signal-detection workflows.

MAUDERecallsUDIGUDID

Clinical Affairs & CER

Build literature appendices for EU MDR/IVDR clinical evaluations. Pull PubMed, ClinicalTrials.gov, and equivalent-device evidence in minutes.

PubMedClinicalTrialsMeSHFull text

R&D and Discovery

Map indications to ICD-10 and LOINC, look up gene targets and ClinVar variants, and pull HPO terms for diagnostic device design.

ICD-10LOINCClinVarHPOUMLS

Market Access

Query CMS coverage decisions, look up physician fee schedules, and map procedures to provider taxonomies for go-to-market planning.

CMSCoverageFee ScheduleNPPES

Competitive Intelligence

Track competitor 510(k)s, watch new entrants by product code, monitor recall trajectories, and read drug labels for combo products.

Competitor 510(k)RecallsDrug LabelsOrange Book
The plumbing

Every authoritative source, one ask away.

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.

openFDA — Devices

510(k), PMA, classifications, recalls, adverse events, enforcement, UDI.

22 tools

openFDA — Drugs

Labels, NDC directory, FAERS, recalls, shortages, Orange Book, CRLs.

18 tools

PubMed

30M+ citations with full-text retrieval and citation graph traversal.

7 tools

ClinicalTrials.gov

500K+ studies with status, phase, intervention, and outcomes filters.

3 tools

DailyMed & SPL

Structured product labeling for drugs and combination products.

3 tools

CDC

WONDER, vehss, open datasets — disease surveillance and mortality data.

5 tools

NIH & NCBI

Funded projects, gene datasets, ClinVar variants, EVS concepts.

10 tools

RxNorm & RxClass

Normalized drug naming, class hierarchies, related concepts.

5 tools

Coding Standards

ICD-10-CM, LOINC, HPO, UCUM, MeSH, UMLS — interoperability backbone.

9 tools

NPPES Providers

2M+ U.S. healthcare providers with NPI, specialty, location.

2 tools

CMS

Coverage decisions, physician fee schedule, provider enrollment.

4 tools

USPSTF & MedlinePlus

Preventive recommendations, consumer drug and lab references.

5 tools
From question to citation

Three steps. No portals.

You ask. The model picks the right tool. You get a sourced answer back.

STEP 01

Ask in plain English

Type the question the way you'd ask a colleague. No API keys, no query syntax, no NDC numbers needed.

you ▸ "Pull all 510(k) clearances for absorbable bone fixation devices since 2024."
STEP 02

Regiome picks the right tool

The model selects from 150+ tools — searching, resolving codes, joining cross-references where it needs to.

tool ▸ search_device_510k_clearances
filters ▸ product_code=HWC, date≥2024-01-01
STEP 03

Get cited, structured answers

Every fact carries the source. Export to a table, drop into a CER, or hand off as a Word doc.

result ▸ 12 clearances
cite ▸ K243... · openFDA, accessed today
In practice

What it sounds like at your desk.

Four questions, the way teams already ask them. Each runs in under a minute.

Regulatory Affairs
"Find me three good predicate candidates for our absorbable suture anchor, with their clearance summaries."
Resolve product code via search_device_classifications
Filter recent clearances with search_device_510k_clearances
Pull full clearance summaries via get_device_510k_clearance
Returns: 3 ranked predicates with K-numbers, applicants, statement summaries, and links to FDA summaries — ready to paste into your 510(k) submission worksheet.
Post-Market Surveillance
"What MAUDE signals have shown up for our infusion pump SKU in the last 6 months versus the prior 6?"
Resolve UDI to brand & model with parse_gudid_udi
Pull event windows from search_device_adverse_events
Cross-check open recalls via search_device_recalls
Returns: Event-type breakdown with delta vs. prior period, top failure modes, narrative excerpts, and any related Class II/III recall actions.
Clinical Affairs · CER
"Build me a literature appendix on transcatheter aortic valve outcomes for our MDR clinical evaluation — last 5 years, RCTs and registries only."
Expand MeSH synonyms via search_mesh_terms
Filter studies with search_pubmed + search_clinical_trials
Bundle metadata + abstracts via resolve_pubmed_article_bundle
Returns: A formatted bibliography with PMIDs, study designs, sample sizes, primary endpoints, and exclusion rationale — exportable as a Word doc with tracked references.
Market Access
"Does Medicare cover the procedure our diagnostic uses, what's the fee schedule, and how many cardiologists nationwide could bill it?"
Pull NCDs & LCDs from query_cms_coverage_api
Lookup rates with query_cms_physician_fee_schedule
Count providers via search_nppes_providers
Returns: Coverage status by MAC, national average reimbursement, billing taxonomy counts by state — enough to size the addressable market for a deck.
The full toolkit

Twelve domains. One unified API.

Browse what's connected. New tools ship as the underlying data sources expose them.

FDA Devices

22
  • 510(k)
  • PMA
  • Classifications
  • MAUDE
  • Recalls
  • Enforcement
  • UDI
  • GUDID
  • Registration
  • Serology

FDA Drugs

18
  • Labels
  • FAERS
  • NDC
  • Recalls
  • Shortages
  • Orange Book
  • CRLs
  • Drugs@FDA

Research Literature

7
  • PubMed search
  • Full text
  • Related
  • Bundle
  • MeSH
  • OpenAlex

Clinical Trials

3
  • Search studies
  • Get trial
  • Status

Drug Terminology

8
  • RxNorm
  • RxClass
  • RxTerms
  • SPL
  • UNII
  • Substances

Coding & Terminology

9
  • ICD-10-CM
  • LOINC
  • HPO
  • UCUM
  • UMLS
  • EVS

NIH & Genomics

10
  • NIH projects
  • NCBI genes
  • ClinVar
  • NCI GDC
  • Publications

CDC & Public Health

5
  • WONDER
  • VEHSS
  • Open datasets
  • Metadata

Reimbursement

6
  • CMS coverage
  • Fee schedule
  • Enrollment
  • NPPES
  • Datasets

Adjacent FDA

8
  • Food
  • Cosmetic
  • Tobacco
  • Animal/Vet
  • Historical docs

Consumer References

5
  • MedlinePlus
  • USPSTF
  • Conditions
  • Lab tests

Resolve & Compose

4
  • Device profile
  • Drug profile
  • Article bundle
  • Citations
Why teams choose Regiome

Faster answers. Stronger evidence. Less swivel-chair.

25+

Sources unified

One connector reaches every FDA, NIH, CDC, CMS, and NLM endpoint.

Rx+Dx

Drugs and devices

Full FDA regulatory depth — 510(k), PMA, MAUDE, FAERS, Orange Book, labels.

100%

Cited answers

Every fact tags its canonical source — K-numbers, NCT IDs, PMIDs — so you can verify.

Live

No caching

Queries hit the official endpoints — what the agencies publish is what you get.

Common questions

The quick answers.

Where does the data come from?
Every tool maps to a public, authoritative endpoint — openFDA, PubMed E-utilities, ClinicalTrials.gov API, CDC WONDER and Open Data, CMS Data, NIH RePORTER, NCBI Datasets, UMLS, RxNav, and others. Regiome doesn't store or cache; it queries live.
Is any internal or PHI data involved?
No. Regiome reads only public regulatory and research data. It is not connected to internal complaint files, EHRs, or any PHI source. Anything internal you reference in the chat stays in the chat — it isn't sent to the data sources.
Can I trust the citations for regulatory submissions?
Citations point to the canonical records (K-numbers, PMA numbers, NCT IDs, PMIDs, NCD/LCD numbers). They are suitable as starting points for submissions, but final regulatory work should always be verified against the source page. Regiome links to those pages directly.
How do I get access?
Regiome serves pharma, medical-device, and clinical-research teams. Request access and we provision your connector endpoint at https://mcp.regiome.io/mcp plus an API key. Add it to Claude or ChatGPT as a custom connector and you're querying in minutes. See the connect steps.
Can Regiome hand off to other tools?
Yes. Results can be exported to Word, Excel, or PowerPoint for CERs, dossiers, and decks. The Word skill produces fully formatted documents with tracked citations; the Excel skill builds tables ready for filtering.
What if my team has a workflow that isn't covered?
Tell us. The Regiome team adds tools and pre-built workflows as customers request them — recent additions span vigilance-report drafting, EUDAMED parity, and clinical-investigator background packs.
Connect in minutes

Add it once. Use it everywhere.

Add Regiome to Claude or ChatGPT as a custom connector with your endpoint and key — no install, no scraping, no glue code.

MCP URL https://mcp.regiome.io/mcp
Request access →
01

Request access

Tell us your team and use case — we provision your endpoint and API key.

02

Add it as a custom connector

In Claude or ChatGPT: Settings → Connectors → Add custom connector, paste your Regiome URL.

03

Authenticate & ask

Add your key once, then ask in plain English. Cited answers come back in seconds.

From access to your first cited answer in minutes.