The AI layer for
clinical data
One platform for medtech teams to search, analyze, and act on data across 40+ specialized clinical and regulatory databases.
Class II cardiac monitors, 510(k) cleared, last 18 months
CardioTrack Pro Monitor
K231456 · MedVista Inc.
HeartSync Wireless ECG
K230892 · PulsePoint Medical
VitalEdge Cardiac Hub
K232104 · Nexion Health
47 results · 1.2s · 3 databases
View all →Platform
Six tools,
one interface
Everything your regulatory and clinical teams need — from literature search to submission.
Clinical Search
Natural language queries across PubMed, FDA MAUDE, 510(k), and ClinicalTrials.gov. Our medical NLP understands device taxonomy, ICD codes, and regulatory classification.
Class II cardiac monitors, 510(k), last 18mo
47 results · 1.2s · 3 databases
Regulatory Intelligence
Real-time alerts on FDA guidance, EU MDR updates, and classification changes.
Team Workspaces
Shared environments for R&D, Regulatory, and Clinical teams. Annotate, assign, and track milestones.
Data Integration
Connect LIMS, QMS, and EHR systems. Unified API for 40+ databases with normalized schemas.
Compliance & Safety
Auto-generate predicate comparisons, clinical evaluation reports, and equivalence arguments. Monitor MAUDE reports for safety signals in your device category.
Product
See the platform
AI-Powered Search
Query 40+ clinical and regulatory databases with natural language
"Orthopedic fixation devices, Class II, 510(k) cleared 2024–2026, with biocompatibility data"
FDA 510(k)
23 devices
PubMed
147 papers
ClinicalTrials.gov
12 trials
MAUDE
89 reports
How it works
Data to decisions
in three steps
Connect sources
Integrate QMS, LIMS, and document repositories via our secure API. HL7 FHIR, DICOM, and REST supported.
Query in plain English
Ask complex clinical and regulatory questions. Our AI understands device taxonomy and regulatory frameworks.
"Find predicate devices for Class II orthopedic fixation, 510(k), last 3 years"
Generate documents
Transform results into submission-ready reports aligned with FDA, EU MDR, and ISO 14971.
Millions
Public records indexed
40+
Database sources
47
Regulatory jurisdictions
Use cases
Built for every stage
Accelerate 510(k) preparation
Automate predicate identification, generate substantial equivalence arguments, and build comparison matrices — in hours instead of weeks.
Weeks→Hours
Time savings
Indexed
FDA databases
End-to-end
Workflow
Databases
40+ sources, one query
FDA 510(k)
Regulatory
PubMed / MEDLINE
Literature
ClinicalTrials.gov
Clinical
FDA MAUDE
Adverse Events
EU EUDAMED
Regulatory
GMDN Codes
Classification
ICD-10 / ICD-11
Classification
Cochrane Library
Literature
WHO ICTRP
Clinical
PMDA (Japan)
Regulatory
Health Canada
Regulatory
ANVISA (Brazil)
Regulatory
+ 28 more across regulatory, clinical, and literature sources
Technology
Purpose-built
for medtech
Not a generic AI wrapper. NexaMed's models are trained specifically on clinical and regulatory data, with domain-specific evaluation benchmarks and safety guardrails.
Architecture
Interface Layer
Search · Workspaces · API
AI Engine
NLP · Retrieval · Generation
Data Layer
40+ Databases · Internal Sources
Security
Encryption · RBAC · Audit · Compliance
Medical NLP Engine
Trained on millions of public clinical records. Understands MeSH terms, GMDN codes, ICD classifications, and regulatory nomenclature.
Multi-Source Retrieval
Federated search across 40+ databases with source-specific optimization. Results deduplicated, normalized, ranked.
Document Generation
Transformer-based generation fine-tuned on successful submissions. Structured for FDA, EU MDR, and ISO templates.
Version-Controlled Data
Every database snapshot versioned. Reproduce any historical query. Full provenance from source to output.
Agentic Workflows
Chain multi-step tasks into pipelines. Predicate search → matrix → equivalence → submission package.
Structured Model Updates
Periodic model updates informed by user feedback, with full version control and validation per FDA AI/ML guidance.
Request early
access
NexaMed is available to a select group of early contributors. Tell us about your team.