How to classify Apple Watch? Medical equipment or diagnostic wearable

It is reported that Apple Apple Watch will be listed after the Chinese New Year.

The release of Apple Watch marks Apple's high-profile entry into the medical market. Although Apple did not elaborate on the integration of Apple Watch and their health applications, there is indeed a lot of potential for this application.

In response, Apple has appointed Michael O'Reilly, the new vice president of medical treatment for Apple Watch, to participate in health-related product development. In addition to hiring Michael, Apple also invited two biomedical doctors from the medical industry to join: Dr. Stephen H. Friend, co-founder and chairman of Sage Bionetworks, a non-profit biomedical research organization, and Dr. Dan Riskin, Vanguard Medical Founder and CEO of Technologies, and an associate professor of surgical counseling at Stanford University. Vanguard is a medical technology incubator that has launched many products and subsidiaries in the medical industry.

Obviously, there are already many medical experts on Apple's Apple Watch team, so can it be classified as a regulated medical device now?

According to preliminary guidelines issued by the US Food and Drug Administration (FDA) on Tuesday, any wearable device that is intended to be classified as a medical device must demonstrate that it can treat a particular disease or condition. Conversely, this type of device can only be considered a normal health accessory, not a regulated medical device. Specifically, wearable devices for "ordinary health" accessories are defined by the FDA to include the following functions: weight management, physical health, relaxation or stress management, mental sensitivity, self-esteem, sleep management, or sexual function.

In summary, Apple Watch can only be classified as a diagnostic class. In addition, from the perspective of the function of health accessories: weight management, physical health, relaxation or stress management, it is once again judged that Apple Watch should be classified as diagnostic rather than medical.

However, from the perspective of the long-term demand development of the market and the overall team building of Apple Watch, Apple seems to have great expectations for Apple Watch to enter the medical device market, although the data collected by Apple Watch is not enough to diagnose the disease, but Data such as heart rate, sleep cycle, and activity level can indeed help determine a patient's health. Data from Apple Watch can help diagnose health conditions such as high blood pressure.

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