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  • Gabriel Signorelli

Is the new Apple Watch 4 a medical device?


Last week, Apple released the new iPhone XS. At the annual iPhones launch event, an amazing show that rarely disappoints, a new version of Apple's smartwatch was also announced. As you can see from the recorded talk on the company website, much of the presentation of Apple Watch 4 was devoted to health.

Image: Apple Watch 4, principal areas of interest: Connectivity, Fitness & Health

“Apple Watch has become an intelligent guardian for your health!” - Jeff Williams, Apple’s chief operating officer

The technical improvements over the old model are basically that it is slightly larger, with better use of the screen (about 30% more), and a longer life battery. But undoubtedly, it was in health that Apple invested in this model.

Great news

There were two big headlines regarding health management with the new Apple Watch 4. The first was the fall detector, which through analysis of specific movements can identify a fall and present a shortcut on the screen for a quick connection to emergency services. If it is not deactivated in 5 seconds, an emergency notification is sent to a selected emergency network and automatically initiates an emergency call.

The second and more impactful is the EKG, the integrated electrocardiogram that the new Apple Watch 4 is capable to register. In addition, a real-time detection function of anomalies in the heart rhythm was also introduced. The two appeals were filed as FDA clearance holders [FDA Irregular Rhythm Notification Feature:][FDA ECG App].

Are they valid?

I do not like to be negative with the eHealth news, but a reflection must always be added before we accept it as a reality.

About the fall detection functionality, the usability and emergency procedures seem well designed. These systems have been widely debated for some years in the technology health papers and conferences, and their importance is always emphasized.

The system seems to be socially important. The problem is that most studies with fall have involved devices placed on the waist of the person, which has a high representation of the subject's center of gravity, and obviously with Apple Watch 4, the sensor will be on the wrist. However, recent studies have also shown good support in relation to the standard movements of the arms during a fall within the fall itself (KhojastehSB, 2018, Gjoreski M, 2016). However, it is true that I could not find robust data on this system. We will have to wait to see the result in the general public, and avoid activating this mode during physical exercises and in young people who move with more speed and amplitude.

EKG – Apple Watch 4 Electrocardiogram

In addition to the 30-second electrocardiogram that you can analyze “anytime, anywhere”, the new Apple Watch 4 will analyze your real time heart rate in the background and can detect whether your HR is too low, too high, and even changes which may suggest heart problems such as atrial fibrillation. Apple made a point of mentioning that these functions received FDA clearance, and even invited Dr. Ivor J.Benjamin, president of the American Heart Association - AHA to talk about the new technologies on the stage.

“I am inspired by the life saving potential of technology!” - Ivor J Benjamin, MD. President of AHA

The potential of technology in providing real-world data is indisputable, but certainly, with the fast advancement of technologies and the growing demand for innovations to sustain increased consumption, we have to be careful to buy certain ideas.

Receiving FDA clearance requires a number of formalities that ensure the scientific quality of the product/medicine, but an FDA clearance does not mean the same as “approving” them. The FDA did not certify and release the Apple Watch 4, it allowed it to be reported generically as related to cardiovascular health, but in the clearance letter, it made notes that it should not be used in patients who already have a history of atrial fibrillation or under 22 years old. In no way does this take away the merit and potential of the new Apple Watch 4, but we just have to be more careful about buying an idea of approval when in fact it was a clearance.

The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.”

Should I buy an Apple Watch 4 as a medical device?

I believe that the new functions presented have sufficient quality if used correctly. Even Apple have emphasized that the AppleWatch 4 is the first device with ECG that is offered directly to consumers. I believe that the orientation of a health and technology professional is very important for its correct use, which would avoide possible misunderstandings with reports generated from misuse, that could lead the user to think that they have problems which would generate anxiety and thus worsen the consumer's health.

While believing in this quality, it makes me a little apprehensive that Apple has not cited or made information readily available to find - open access studies that validate the use of new medical functions of Apple Watch 4. If you have the product with that potential and probably followed rigid procedures to submit to the FDA, it would be logical to think of promoting its scientific validity.

Finally, I still particularly think that there is a lack of connectivity and relationship between Apple Watch and other Apple devices that could make it indispensable when compared to other smartwatches that also communicate with iOs and are much cheaper. In the talk itself, nothing was commented on the integration of Apple Watch 4 with the new iPhones.

#catchitn #MSCA #wearables #exercise #physicalactivity #AppleWatch #technology #eHealth

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