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Browse AI devices by specialty, country of approval and algorithm type. Search 1 000+ products updated daily from FDA and EUDAMED feeds.
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The independent guide to commercially cleared AI medical devices. Rigorous evaluation. No advertising.
1,304+
Devices indexed
3
Auris Mark tiers
7
Jurisdictions
Daily
Evidence updates
“Certified. Curated. Clinical.”
Every device evaluated on the same evidence standard. Independent of manufacturers. Accountable to clinicians.
Compare
Put 2–5 devices side by side across regulatory status, clinical evidence and AI algorithm characteristics. Export a procurement-ready dossier.
Track
Build a personal watchlist — keep the devices you follow, with their current approvals and last-reviewed dates, in one place.
Two reasons clinicians come back.
Different stakes, the same evidence standard.
For Doctors
Before you recommend.
The product brief is glossy, the FDA letter is opaque, and the relevant trial sits behind a paywall.
One page per device — what's cleared, what the evidence actually shows, and where each claim is sourced.
For Clinical Leaders
Before you budget.
Six manufacturers, three jurisdictions, two months of due diligence — and the regulatory landscape moves while you read.
A trending view across categories, jurisdictions and clinical evidence, refreshed daily from primary sources.
Built around the regulatory frameworks you trust.
Five frameworks shape what reaches a clinic — and what doesn’t. Every device card surfaces the approvals that matter to your decision, colour-coded so you can scan a worklist at a glance.
FDA
The US Food & Drug Administration's gateway for medical devices. Most AI tools enter via 510(k) clearance (substantial equivalence to a predicate); novel devices route through De Novo or, for the highest-risk products, a Premarket Approval (PMA).
CE MDR
The EU Medical Device Regulation (2017/745) — the conformity assessment a device needs before it can be marketed across the EU. Replaces the old MDD; risk class (I, IIa, IIb, III) drives how strict the assessment is.
IVDR
The EU In-Vitro Diagnostic Regulation (2017/746) — sister regulation to MDR, governing diagnostic devices that analyse specimens (blood, tissue, imaging-derived biomarkers). Most AI pathology and lab tools are classified here, not under MDR.
AI Act
The EU AI Act risk classification overlay. Most clinical AI is in the high-risk tier and inherits additional obligations on data governance, human oversight, and post-market monitoring. Limited and minimal-risk classes apply to lower-stakes use.
UKCA
Post-Brexit UK conformity assessment, currently running in parallel with continued CE recognition under MHRA's transition rules. A device intended for the UK market typically needs UKCA (or at minimum a clear MHRA registration path).
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FDA AI/ML 2026 mid-year review
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EU AI Act: what 'high-risk medical' really excludes
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How to read a substantial-equivalence letter
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The standard of record for AI medical device approval, evidence, and clinical trust.
Independent. Editorial. Daily updates from FDA, EUDAMED, and the peer-reviewed literature.