Certified Health Apps

All apps · Diabetes & metabolism

Certified diabetes apps and devices

70 diabetes apps and devices, each checked against the FDA register, EUDAMED and the German DiGA directory. Last checked 18 October 2026.

51FDA verified
8CE class IIa or higher
5German DiGA
6no matching FDA record

Diabetes is the most regulated area of digital health. Continuous glucose monitors, insulin pumps and dosing algorithms are medical devices, and most of them carry an FDA authorisation. At the same time, it is the area with the most confusing labels: a cleared meter does not make its app cleared, and a well-known brand does not make a claim true.

Below you find every diabetes tool in our directory, grouped by what we could verify in the official registers.

Digital diabetes care: the certified landscape 2026
Our landscape report for pharma, payers and hospitals: six segments, 71 tools, with an auditable verification level for every FDA entry. See the report · Free sample

In the US: FDA verified (51)

Authorised by the FDA (510(k), De Novo or PMA), newest decisions first.

In the EU: CE class IIa or higher (8)

Found in EUDAMED as class IIa or higher. We show whether a notified body certificate is visible there.

In Germany: DiGA (5)

Listed in the German directory of reimbursed digital health applications.

Watchlist (6)

These products are presented as certified, by their maker or in earlier directories, but we found no matching record in the official register, or they are no longer supported by their maker. Some are registered and listed with the FDA as exempt devices, which is legal but is not a clearance.

The trap to avoid

Check that the authorisation names the product you recommend. Many glucose meters are cleared while the app that patients use every day is not named in the record, and some newer sensor variants are only covered as part of a product family. No number, no certification.

Questions

Which glucose sensors can be bought without a prescription?

In the US, the FDA has cleared four sensors for over-the-counter sale to people who do not use insulin: Dexcom Stelo, Abbott Libre Rio, Abbott Lingo and Signos. Availability in Europe differs per country.

Are diabetes apps reimbursed in Germany?

Yes. The German DiGA directory lists digital therapies for type 2 diabetes, such as glucura and Vitadio, and for obesity, such as Oviva and zanadio, which doctors can prescribe and health insurers reimburse.

Does CE marking mean a diabetes app is safe?

Not always to the same degree. CE class I is self-declared by the maker. Class IIa and higher requires a review by a notified body, which is what you should expect for any app that calculates an insulin dose.

Is an FDA clearance valid in Europe?

No. An FDA authorisation applies to the US. In the EU, a medical device app needs a CE mark; ask the maker for the certificate and the notified body number.

Certification status changes. Always confirm in the official register before relying on it. Not medical advice.

Search the full directory · Free guide: how to check a health app in two minutes