Search FDA AI medical-device evidence, from 510(k) predicates through payment.
Search source-linked 510(k) summaries, validation designs, and predicate chains; monitor MAUDE, recalls, warning letters, and Form 483s; and trace documented reimbursement pathways. Built for regulatory, quality, clinical-evidence, and market-access teams.
One source-linked record across the device lifecycle
Live FDA / CMS sources
Clearances · recalls · adverse events · warning letters · Form 483s · payment records
Precedent
1,491 devices parsed
“Devices like mine” answers
Postmarket
1,505 snapshotted · 8,571 signals
Per-device drift signals
Reimbursement
40 pathways
Payment pathways + $ amounts
Radar
category checks · firm history · monitored changes
Category evidence signals
Open a track
Precedent · 510(k) search
Find predicate devices and compare the validation evidence FDA accepted — parsed 510(k) summaries, source-quoted fields, and predicate chains.
Postmarket · MAUDE & recall signals
Monitor MAUDE trends, recalls, re-clearances, and disclosed drift signals for FDA-cleared AI/ML devices.
Reimbursement · payment pathways
Clearance → code → NTAP → CMS rate → payer policy. Who got paid, how much, through which mechanism.
Use the evidence
Connect your AI workflow
Put 13 source-linked FDA and CMS evidence tools inside ChatGPT, Claude, Codex, Cursor, VS Code, or your own MCP-compatible agent.
Research
The validation–reimbursement gap, the evidence lifecycle, and the sources behind the product thesis.
For teams
Scoped evidence assessments, configured monitoring, and higher-volume access for regulatory, quality, and market-access teams.
For regulatory, quality, and market-access teams
Scope a 510(k), postmarket, compliance, or reimbursement review
Share a work email and Health AI will follow up to identify the device, product code, decision, evidence boundary, and deliverable. Constat surfaces the public record; a scoped engagement adds documented analyst interpretation.