Apple Watch hypertension tool receives FDA approval

The US Food and Drug Administration (FDA) has cleared Apple’s new hypertension detection feature on Thursday, September 12th.

The approval means that Apple will be able to roll out its blood pressure monitoring capabilities on Apple Watch Series 9, Series 10, Series 11, and the premium Ultra 2 and Ultra 3 models before the end of September to global markets.

Hypertension notifications on Apple Watch collect data from the optical heart sensor to analyse how a user’s blood vessels respond to the beats of the heart, according to Apple. The feature works in the background, collecting and reviewing data over 30-day periods, ready to notify the user if it notices consistent signs of hypertension.

Users who receive a detection alert should log their blood pressure for seven days using a blood pressure cuff and discuss the results with their provider.

This will allow them to adjust their lifestyle or seek treatment promptly. The feature was developed using advanced machine learning and training data from studies with over 100,000 participants, and then reviewed in a further clinical study of over 2,000 participants.

Although it will likely not be able to detect all cases of hypertension, successful detection is expected for over a million people within the first year.

The feature, which was announced during Apple’s latest event, is expected to be rolled out in 150 countries and regions, including the US and Europe.

Alongside the hypertension detection feature, the watches will also include a sleep score to help users understand the quality of their sleep and several advanced fitness features. Apple refers to this as a “first-of-its-kind fitness experience”, offering personalised motivation through a dedicated Workout Buddy.