Certified Health Apps

All apps · Heart & circulation

Certified heart and blood pressure apps and devices

78 heart and blood pressure apps and devices, each checked against the FDA register, EUDAMED and the German DiGA directory. Last checked 18 October 2026.

60FDA verified
14CE class IIa or higher
2German DiGA
1no matching FDA record

Heart care is the largest area in our directory. It covers ECG wearables and patches, blood pressure monitors, smartwatch features and AI that reads cardiac scans. Most of these tools hold an FDA authorisation, and Europe has a strong group of CE class IIa ECG and rhythm apps.

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

Digital heart care: the certified landscape 2026
Our heart and circulation landscape for pharma, payers and hospitals: 7 segments, 78 tools, with an auditable verification level for every FDA entry. See the report · Free sample
Guide: certified at-home blood pressure monitoring See guides and reports

In the US: FDA verified (60)

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

In the EU: CE class IIa or higher (14)

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

In Germany: DiGA (2)

Listed in the German directory of reimbursed digital health applications.

CE class I (self-declared) (1)

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

Watchlist (1)

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

A cleared feature is not a cleared device. A smartwatch ECG or rhythm notification can be authorised while the watch itself, and its other health functions, are not. For cuffless blood pressure, check that the blood pressure function itself is named in the authorisation.

Questions

Is the Apple Watch ECG feature FDA cleared?

Yes. The ECG feature on Apple Watch holds a 510(k) clearance; the most recent decision in our directory dates from 2025. The clearance covers that feature, not every health function of the watch.

Are cuffless blood pressure devices certified?

Some are. In our directory, the Hilo Band (formerly Aktiia) holds a 510(k) cleared in 2025. For any cuffless device, check that the blood pressure function is named in the FDA record or the CE certificate.

Which heart apps are reimbursed in Germany?

The German DiGA directory lists Oviva Direkt for high blood pressure and ProHerz for heart failure. Doctors can prescribe them and health insurers reimburse them.

Is a CE mark enough for an ECG app?

For an app that analyses heart rhythm, expect CE class IIa or higher, which means a notified body reviewed it. Class I is self-declared by the maker.

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