Every AI/ML device, from clearance to payment— live.
Premarket precedent, post-deployment signals, and reimbursement pathways from live FDA and CMS data — plus the 483 compliance layer underneath. Built for regulatory teams who work the evidence directly.
How it works — live data flowing right now
Open a track
Precedent
What evidence FDA actually accepted for devices like yours — parsed 510(k) summaries, source-quoted fields, predicate chains.
Postmarket
MAUDE trends, recalls, and drift signals for the cleared AI/ML cohort — per device, every signal with a source.
Reimbursement
Clearance → code → NTAP → CMS rate → payer policy. Who got paid, how much, through which mechanism.
Work the queue
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client digest · coming soonThe weekly scan already queues new recalls, warning letters, 483 patterns, and score changes for analyst review. The client-facing digest — approved alerts with verdicts, per category — ships next; subscribers get it first.