Latest Apple Watch Gets FDA Approval as a Class II Device

The new version of Apple Watch includes an electrocardiogram feature.

Apple has entered into the medical device arena with its latest version of the Apple Watch. The company recently received approval from the US Food and Drug Administration (FDA) for the electrocardiogram feature in the new Series 4 model smartwatch, which is thus considered to be a medical device. This functionality can be used to alert the wearer about abnormal heart rhythms.

The app for unlocking the wrist-based ECG functionality will be available to U.S. consumers later in 2018. The reading is taken using electrodes built into the watch’s crown and a new heart rate sensor. The user touches and holds the side of the watch, which sends an electric current through the chest to the opposite hand. Heart rhythms are measured and classified after 30 seconds and an alert is sent if there are signs of atrial fibrillation. The data is stored in a Health app in a PDF that can be sent to a physician.

It should be noted that Apple’s ECG functionality is not the first to be offered for the Apple Watch. AliveCor previously received FDA approval for its AliveCor KardiaBand, an attachment for the Apple Watch. 

The Series 4 model Apple Watch also contains an accelerometer and gyroscope that can detect hard falls by analyzing wrist trajectory and impact. An alert is sent to the user if certain criteria are met. If no motion is sensed for 60 seconds after this type of fall, the watch will notify emergency services and any nearby emergency contacts.

These features seem to be targeting older consumers and may be a way for Apple to expand its market beyond young, tech-savvy buyers. The ECG app on the watch, in fact, is only approved by FDA for use by adults 22 and older.

FDA worked closely with Apple as the developed and tested the new health-related features, which the agency believes may help millions of users identify health concerns much earlier than normal. They are also following the activities of numerous other companies investing in digital healthcare solutions from simple apps to virtual home assistance. The FDA, in fact, issued a digital health action plan in 2017 with the intention of streamline approvals for software posing a lower risk than traditional medical devices.


Nigel Walker

Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.