Terms of Use

Aletia Index is operated by Aletia Health (Pty) Ltd. By using the site you accept these terms. If you do not, please do not use it.

A reference work. We collect what public regulatory registers say about AI and machine-learning enabled medical devices, resolve the same device across jurisdictions to a single canonical identity, and present the result so that the question “where is this device cleared, and where is it not” can be answered in one place.

Our sources are the registers themselves — the FDA, the MHRA, EUDAMED and others — together with clinical trial registries and, where a manufacturer has claimed a listing, information they supply. Each device page shows where its information came from and when it was last synchronised.

This matters more than anything else on this page.

• Not medical advice. Nothing here is a clinical recommendation. Decisions about patient care are for qualified clinicians exercising their own judgement.
• Not a regulatory determination. We do not approve, certify, license or endorse any device, and we have no authority to do so. Only the relevant regulator can tell you whether a device may lawfully be supplied or used in a given country. Before you rely on a regulatory status for any decision that matters, verify it against the regulator's own register.
• Not a validation of clinical performance. That a device appears here says only that a regulator cleared it and that we recorded the fact. It says nothing about how well the device works in your setting or on your population.
• Not complete or continuously current. Registers publish on their own schedules, sometimes incompletely; some fields are not publicly retrievable at all. Our records are synchronised periodically, not live.

Where we mark a device as Aletia Verified, that badge means a human reviewer completed our published assurance checklist. It remains our opinion, and it is not a regulatory status.

We take accuracy seriously and correct errors when we learn of them, but we cannot guarantee that every record is complete or up to date. The index is provided as it stands. If you find something wrong — particularly about your own device — tell us at info@aletia-index.com and we will look at it.

A manufacturer may claim its own entry to keep it current. In doing so you confirm that you are authorised to act for that organisation and that what you supply is accurate and not misleading. We may verify a claim, decline it, or withdraw it if it turns out to have been made without authority. Claiming a listing does not give you editorial control of the regulatory information we source from the registers.

You are welcome to read, search, cite and link to the index, including in research and professional work. Please do not attempt to gain unauthorised access to any part of the system, place automated load on it that interferes with other people's use, or extract the database wholesale to reproduce a substantially similar service. If you want bulk or programmatic access, ask us.

Regulatory facts are not ours to own, and we claim nothing over them. The selection, arrangement, canonical identifiers, written analysis and design of the index are ours. Third-party names and trade marks belong to their owners and appear here for identification.

The site is provided without warranties of any kind, to the fullest extent the law allows. We are not liable for loss arising from reliance on the index, including clinical, commercial or regulatory decisions — which is why the verification point above is stated as plainly as it is. Nothing here excludes liability that cannot lawfully be excluded, including for death or personal injury caused by negligence, or for fraud.

We may amend these terms; the date at the top will move when we do, and continued use means you accept the amended version. These terms are governed by the law of the Republic of South Africa, and the South African courts have jurisdiction.

How we handle personal information is set out separately in our Privacy Notice.