FDA-cleared watch features versus wellness estimates

Short answer

A cleared feature has an FDA decision behind the specific claim it makes; 17 watches here carry at least one, 15 of them an ECG. Heart rate, blood oxygen, VO2 max and sleep scores are wellness estimates.

What clearance means

A feature that claims to detect or notify about a medical condition, such as atrial fibrillation on a single-lead ECG, irregular rhythms, possible sleep apnea or possible hypertension, is a medical device in the US. It reaches the market through a 510(k) clearance or a De Novo grant, both searchable in the FDA's public databases. The clearance covers that claim, for the population it was tested in, and nothing broader.

Features the maker presents only for general wellness, such as resting heart rate trends, blood oxygen, stress, HRV, VO2 max and sleep or readiness scores, fall under the FDA's general wellness policy and need no clearance. They can be useful for your own trends; they are not diagnoses.

Which watches carry which

Watches here with a cleared ECG: Apple Watch Series 12, Apple Watch Ultra 4, Samsung Galaxy Watch9, Samsung Galaxy Watch Ultra2, Samsung Galaxy Watch8 Classic, Google Pixel Watch 5, Google Pixel Watch 4, Fitbit Sense 2, Garmin Forerunner 970, Garmin Venu 4, Garmin fēnix 9, Garmin fēnix 9 Pro, Garmin Enduro 4, Withings ScanWatch 2, Withings ScanWatch Nova. Each watch page lists its cleared features with the decision number the maker or the FDA cites.

Some cleared features need a specific phone: Samsung's ECG runs through an app on Samsung phones, and each watch page quotes the maker on that.

Sources

Maker claims quoted on this page are the maker’s own and are labelled as such. This page is general information, not medical advice.

Watches this comes up with

Apple Watch Series 12 smartwatch
Apple~$399

Apple Watch Series 12

Everyday smartwatch · watchOS

iPhone onlyPaid tier: Apple Fitness+4 FDA-cleared features
smartwatch mode
24 h
always-on display
not published
GPS workout
10 h
  • 24 h battery
  • FDA-cleared ECG
  • Hypertension alerts

Best for: iPhone owners who want the full Apple health suite and don't need multi-day battery

Samsung Galaxy Watch9 smartwatch
Samsung~$380

Samsung Galaxy Watch9

Everyday smartwatch · Wear OS

Android; some features need the maker's own phone2 FDA-cleared features
smartwatch mode
40 h
always-on display
30 h
GPS workout
not published
  • 30 h with AOD
  • Dual-band GPS
  • FDA-cleared ECG

Best for: Samsung Galaxy phone owners who want a light everyday watch with full health features

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