Certified Health Apps

All apps · Brain & nerves

Certified apps and devices for brain and nerve conditions

46 brain and nerve apps and devices, each checked against the FDA register, EUDAMED and the German DiGA directory. Last checked 18 October 2026.

29FDA verified
4CE class IIa or higher
5German DiGA
5no matching FDA record

Neurology combines some of the most advanced tools in digital health: seizure detection wearables, migraine and tremor neuromodulation, concussion assessment and AI that reads stroke scans. In Germany, digital therapies for multiple sclerosis, aphasia and memory are reimbursed.

Below you find every brain and nerve tool we track, grouped by what we could verify in the official registers.

Digital neurology: the certified landscape 2026
Our brain and nerves landscape for pharma, payers and hospitals: 6 segments, 46 tools, with an auditable verification level for every FDA entry. See the report · Free sample

In the US: FDA verified (29)

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

In the EU: CE class IIa or higher (4)

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.

CE class I (self-declared) (3)

Self-declared by the maker, without review by a notified body. We list these apart.

Watchlist (5)

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 the indication, not only the clearance. A neuromodulation device can be cleared for one condition (for example migraine or essential tremor) and marketed more broadly. The FDA record states what it is cleared for.

Questions

Are there FDA-cleared seizure detection wearables?

Yes. In our directory, EmbracePlus and EpiMonitor (Empatica), EpiWatch and Nelli hold 510(k) clearances from 2025. They alert caregivers; they do not replace clinical diagnosis.

Which migraine devices are FDA cleared?

Nerivio, a remote electrical neuromodulation armband controlled by an app, holds a 510(k) with a 2025 decision in our directory.

Is there a cleared device for essential tremor?

Cala Trio, a wrist-worn stimulator, holds a 510(k) with a 2026 decision in our directory.

Which neurology apps are reimbursed in Germany?

The DiGA directory lists elevida and levidex for multiple sclerosis, neolexon Aphasie for aphasia, memodio and NeuroNation MED for mild cognitive impairment.

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