Certified Health Apps

All apps · Mental health

Certified mental health apps and digital therapeutics

49 mental health apps and devices, each checked against the FDA register, EUDAMED and the German DiGA directory. Last checked 18 October 2026.

15FDA verified
5CE class IIa or higher
25German DiGA
2no matching FDA record

Mental health is where Europe leads. Germany has listed more digital therapies for mental health than for any other area: depression, anxiety, panic, stress, eating disorders, smoking and ADHD. In the US, a smaller group of prescription digital therapeutics holds FDA authorisation.

Below you find every mental health tool we track, grouped by what we could verify in the official registers. Meditation and wellbeing apps without a medical claim are not medical devices and are not listed here.

Digital mental health: the certified landscape 2026
Our mental health landscape for pharma, payers and hospitals: 6 segments, 49 tools, with an auditable verification level for every FDA entry. See the report · Free sample

In the US: FDA verified (15)

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

In the EU: CE class IIa or higher (5)

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

In Germany: DiGA (25)

Listed in the German directory of reimbursed digital health applications.

CE class I (self-declared) (2)

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

Watchlist (2)

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

Clinical sounding language is not a certification. Many mental health apps describe themselves as evidence-based or clinically proven without holding any medical device status. Look for a DiGA listing, a CE certificate of class IIa or higher, or an FDA number.

Questions

Is there an FDA-authorised app for depression?

Yes. Rejoyn, cleared in 2024, is a prescription app used alongside antidepressant medication. In Germany, several depression therapies such as deprexis, Selfapy Depression and HelloBetter apps are listed as DiGA.

Is there an FDA-authorised treatment for ADHD in children?

EndeavorRx, a video game based treatment, is authorised through the De Novo route for children with ADHD. In Germany, hiToco ADHS Elterntraining and ORIKO ADHS-Therapie are listed as DiGA.

How many mental health apps are reimbursed in Germany?

Our directory lists 25 German DiGA in mental health, from depression and panic to eating disorders and smoking cessation.

Are meditation apps certified?

Generally not. Apps for relaxation or general wellbeing do not make a medical claim, so they are not medical devices. That does not make them useless, but it means no regulator has reviewed them.

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

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