Certified Health Apps

All apps · Vital signs & remote monitoring

Certified remote monitoring and vital signs tools

72 remote monitoring and vital signs apps and devices, each checked against the FDA register, EUDAMED and the German DiGA directory. Last checked 18 October 2026.

51FDA verified
13CE class IIa or higher
0German DiGA
8no matching FDA record

Remote monitoring moves measurement from the hospital to the home: wearable patches, smart rings, contactless sensors, and apps that read heart rate or breathing from a phone camera. It is also the area where platform claims are most often unclear.

Below you find every remote monitoring and vital signs tool we track, grouped by what we could verify in the official registers.

Remote patient monitoring: the certified landscape 2026
Our remote monitoring and vital signs landscape for pharma, payers and hospitals: 5 segments, 72 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 (13)

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

Watchlist (8)

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 remote monitoring platform is often not a medical device itself: the devices it connects to are. When a platform says it is FDA cleared, ask which component is cleared, and under which number. Eight platforms in this area are on our watchlist for exactly that reason.

Questions

Can a phone camera measure vital signs with FDA clearance?

Yes, for specific measurements. In our directory, Anura, PanopticAI Vital Signs, SmartSpectra and Faceheart hold 510(k) clearances from 2025 or 2026. Each clearance covers specific vital signs, so check which ones.

Is the Owlet sock a medical device?

The Owlet Dream Sock is authorised by the FDA through the De Novo route. Earlier Owlet socks were sold as wellness products, so check which model you have.

Are smart rings medical devices?

Most are not. In our directory, a blood oxygen version of the RingConn ring (made by Ninenovo) holds a 510(k). For other rings, a health score or sleep score is a wellness feature, not a certified measurement.

Do remote monitoring platforms need a CE mark in Europe?

Software that monitors patients for a medical purpose is a medical device in the EU. In our directory, Luscii, Huma and Tucuvi, among others, are listed in EUDAMED with CE class IIa or IIb.

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

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