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Apple Watch’s Pathway to Medical Devices (Cyber ​​Weekend)

Since Apple introduced the first Apple Watch in mid-2015, the market for wearable IT devices has continued to change. Especially in an era when consumers are becoming more interested in health.

Data from several research organizations reported similar that over the past year. The total market of smartwatches worldwide has grown by more than 18% and 2021 is expected to show similar growth in 2021. With the main factors that make consumers even more interested Is a matter of collecting health data from emerging technologies Help the user detect any unusual symptoms. Before seeing from the annual health check

Previously in the health wearable device market Other than apples There will be device manufacturers to detect the movement of the body like Fitbit (Fitbit) and Garmin (Garmin) that focus on exercise data. Followed by the smartphone manufacturers who turned to produce even more smartwatches.

But most smartwatches on the market can only collect activity data. And primary health Like steps Heart rate Collect sleep data Exercise Until measuring the oxygen in the blood Which has become a standard feature that comes with modern smart watches


Until today, Apple Watch in Thailand has been approved by the Food and Drug Administration. (FDA) to be a type 1 medical device or a device that focuses on in vitro diagnostic examination Low Individual Risk, Apple released overseas features in 2018, such as Electrocardiogram (ECG or EKG), is now available in Thailand. It will upgrade Apple Watch functionality into a data storage device that can be used in conjunction with additional doctor diagnoses.

*** Timeline for all 8 models of Apple Watch


Apple has now sold eight major Apple Watch models since the first Apple Watch launched in 2015, acting as a smart watch for notifications. And store exercise data

It was first developed to be the Apple Watch Series 1 and 2, released together in 2016 with the addition of a heart rate sensor, followed by the Apple Watch Series 3 in 2017, adding a Cellular model, allowing it to send notifications Emergency alert (SOS) with the addition of a height sensor

This will continue with the Apple Watch Series 4 in 2018, a major turning point for Apple to demonstrate a greater commitment to collecting heartbeat data. With the addition of an electrocardiogram sensor And the fall detection system is used to alert the elderly when falling.

While Apple Watch Series 5 in 2019 will focus on improving the display to keep the screen always on. Reducing the battery consumption of the screen as a whole, focusing on improving the efficiency of use.

Before coming to the last two models is the Apple Watch Series 6 that increases the ability to measure blood oxygen. Increased accuracy in measuring heart rate, and the low-cost Apple Watch SE is available to replace the outgoing Apple Watch 4 and 5.

Currently, Apple has options to market all three Apple Watch models, Apple Watch 3, Apple Watch SE and Apple Watch Series 6, starting at 6,400 baht, 9,400 baht and 13,400 baht, respectively.

*** Features for health

The FDA has approved Apple Watch as a medical device. Resulting in the apple Can enable features such as ECG measurement To be used in Thailand now Which turned out to be Thai It was activated simultaneously with Japan, while there were still many countries where this feature was not enabled.


People who use Apple Watch Series 4 or later when updating watchOS to version 7.3 and iPhone to iOS 14.4 will be able to activate this feature immediately in the Health app. Date of birth to confirm activation again

Previously, there have been clinical trials with approximately 545 patients examining the ability to use their Apple Watch to measure ECG. To detect the heartbeat in atrial fibrillation (AFib) and normal heartbeat patterns. (Sinus rhythm) was found to have AFib detection sensitivity of 98.5% and sinus tachycardia at 99.3%, indicating the accuracy this occurred.

In addition to the ECG feature, what Apple Added with this update is a feature like ‘Irregular Rhythm Notifications’, the special feature of this feature is The heart rate sensor on all Apple Watch models can be used to detect heart rate 5 times over 65 minutes if it detects irregular heartbeats. It will notify the user immediately. In order to receive a comprehensive treatment again

Apple Watch now has a detection feature. And warn about all four types of heart disease together. Beginning at 1. Alert heart beat irregularly 2. Irregular heartbeat alert 3. Irregular Rhythm Alarm and 4. Electrocardiogram for AFib determination.

Only the ECG feature is required for Apple Watch Series 4 and later, excluding the blood oxygen measurement that was added to the Apple Watch Series 6. Users with existing Apple Watch models can access it immediately after a firmware update.

*** Collect information for diagnosis

However, because the data the Apple Watch stores and saves in the Health app. It is not yet considered as the basis for diagnosis. But will be used as a supplement to medical professionals. There is additional information to observe the symptoms. Before re-examining with a medical device in the hospital

So it’s the most important thing to use Apple Watch when you see any unusual warning signs. Should go to see a doctor for a more detailed physical examination. And in the end, it is up to the doctor to use these health information in the diagnosis or not.

At the same time, features like the added ECG are not the main factor in collecting health data. Until the bug has to be saved several times a day or every day and recommended for use when symptoms such as a rapid heartbeat Or only skip a beat So that the collection of this information does not affect the user’s mental health.

However, with the development of ECG on the Apple Watch to detect irregular heartbeat patterns, it was initially not covered by other types of heart disease. Make it a group of users who will benefit from this section. Is a group of the elderly who are primarily likely to develop AFib; Just having intermittent dance reminders is enough.

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