The encyclopedia · Advertising & PR · Marketing decision · 2026
An app ad said your iPhone monitors blood pressure — it was not a medical device
'Your iPhone now supports blood pressure monitoring', the Google ad said. The app measured heart rate only, was unregistered, and could make no medical claims.
Novabeyond · 2026-06-17
What happened
Novabeyond's 'Blood Pressure-Monitor Tracker' app measures heart rate through the phone's camera (photoplethysmography) and lets users log blood-pressure readings taken elsewhere. A Google video ad showed a finger on a screen with SYS/DIA readings fluctuating under the text 'Your iPhone now supports blood pressure monitoring'; an in-app ad said 'Record your heart rate daily — tap your finger'.
The ASA judged that the app's PPG heart-rate function made it a Class IIa medical device — and it was not registered with the MHRA or conformity-marked. For an unregistered device, no medical claims can be made at all. The video ad also directly misled: the visuals implied the phone itself measured blood pressure, which the app cannot do.
On 17 June 2026 the ASA upheld both complaints under CAP rules 3.1, 3.7 and 12.1. The ads must not appear again, and Novabeyond was told not to make medical claims for an unregistered device or imply blood-pressure monitoring it cannot deliver.
Why it happened
- The claim was the product's whole pitch: 'your iPhone monitors blood pressure' described a capability the app does not have.
- Health functionality changes what the app legally is — PPG heart-rate monitoring makes it a medical device, and without registration every medical claim becomes a breach.
- The ad's visuals did the misleading work: fluctuating SYS/DIA numbers under a fingertip say 'measurement' whatever the small print allows.
The lesson
Health claims turn an app into a medical device in regulators' eyes: without registration, no medical claims at all, and the ad carries the liability for the gap.
Aftermath
Novabeyond was told its ads must not reappear in the investigated form and that medical claims require MHRA registration and conformity marking. The ruling sits in a growing line of ASA decisions on wellness apps whose marketing outruns their clinical status.
Sources
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