Is Apple’s Latest Watch a Medical Device?

Is Apple’s Latest Watch a Medical Device?

- October 25, 2018

Since its initial release in September, the new Apple Watch Series 4 has been primarily marketed as an innovative wearable medical device.

Many have praised the updated device as a great leap forward for wearable technology, yet the digital health world has received the product with mixed responses.

New features of the Apple Watch provides users with several health-monitoring capabilities including an FDA approved electrocardiogram (ECG) monitoring app, heart-rate monitoring alerts, and a motion sensor that can alert authorities and emergency contacts after a dangerous fall. FDA Commissioner, Dr. Scott Gottleib assured the public that the FDA had worked alongside Apple to develop new features, stating: “The F.D.A. worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly.”

Advocates of the new Apple Watch argue that for many with a history of cardiovascular issues and fall risks, the benefits of the updated features could prove to be life-saving. In fact, there have already been cases of the Apple Watch aiding in saving patient’s lives.

Yet, many cardiologists and digital health experts have been hesitant to fully support the watch’s updated alert features. Critics claim that the watch’s alert system is susceptible to producing grossly misleading alerts. This is because the amount of data the watch captures is incredibly minuscule in comparison to that of a a traditional electrocardiograph, and thus will likely produce many false-positive results for healthy users, and false-negative results for unhealthy ones. The U.S. Preventive Services Task Force issued a “D” recommendation for screening asymptomatic adults at low risk, for this very reason.

However, whether in support of the new alert features or not, most digital health experts agree that the new Apple Watch has incredible monitoring capabilities that could have profound results for cardiovascular research and physician monitoring. The data gathered from users could allow physicians to discover cardiovascular irregularities earlier and thus treat heart issues before they dramatically advance. In a statement at the watch’s unveiling event, president of the American Heart Association, Ivor Benjamin asserted: “The ability to access health data from an on-demand electrocardiogram or ECG is game-changing.”


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