Overall App Summary:
The Quick BP Measure app presents an interesting idea of being able to measure blood pressure using only a smartphone. However, the fact that the app is not validated is concerning as measurements from it may be very inaccurate and lead users into dangerous situations. The app itself states it is inaccurate on its iTunes page which is a good indication it is not ready for use at this time. When trying to actually use it, the app did not work as specified and it was impossible to even get a reading although perhaps it may work better for others. Overall it would be best not to use this app for clinical use or blood pressure monitoring at this time given concerns about the quality of data/reads and trouble with actually using the app. Furthermore, this app should be considered a “medical device” based on FDA’s definition of a medical device, and needs to undergo the appropriate Class II 510k clearance for use a blood pressure monitoring device. Even under FDA Mobile Medical Application guidance, this app would be one where the FDA would, most likely, enforce its regulatory authority. The Quick BP Measure and Monitor app is an unsafe product and does not belong in the app marketplace.
App’s Intended Use:
According to the developers of the Quick BP Measure mobile app, it “lets you measure BP using only your iPhone” – i.e. without the need for a cuff. The Quick BP Measure app is NOT intended to be used to “diagnose, mitigate, treat, or prevent hypertension or hypotension.” It is for recreational use only.
Who’s this app most useful for?
This app is NOT useful and should not be used by anyone, as it is clearly a “recreational use only” app. The app “magically” provides a blood pressure reading using just the iPhone camera without any external devices. If the app were to be validated at some point in the future for accuracy against a traditional blood pressure cuff/ monitor, then, this mobile app would be tremendously useful for any patient with high blood pressure or anyone wanting to check their blood pressure.
How should one use it?
Patients should be very cautious in using this app because there is no data on reliability and validity of the measurements from this app. The app even says “At this time, results may vary for different users and some users may experience inaccurate measurements. Please bear with us as we improve this exciting new technology.” Thus, we would not advise patients to use this app; as there is a real safety risk in misunderstanding and/or misinterpreting the BP measurements reported by the app.
Not FDA cleared, but eligible under MMA guidance. Also, this mobile app would qualify as a medical device.