Posted on Sep 13, 2018, 5 p.m.
Following FDA classification as a Class II device, the latest iteration of the Apple smartwatch containing an app unlocking the wrist-based ECG functionality will be available to USA consumers in late 2018.
The FDA cleared electrocardiogram is now official classified as a medical device that is capable of altering users to abnormal heart rhythms; accelerometer and gyroscope hardware can also detect hard falls by analyzing wrist trajectory and impact.
There has been great speculation in regards to how and when the tech giant would dive into healthcare waters, and it did a big cannonball with a large splash when unveiling its reimagination of healthcare delivery with the new Series 4 model smatchwatch and its federal de novo clearance at the Apple iPhone launch event in California.
Users receive an alert from the smartwatch which can be used to call for help when needed, if no motion is detected for 60 seconds after a fall it automatically calls emergency services for assistance and notifies emergency contacts with the location.
Apple worked closely with the FDA to develop and test the software products, which are expected to help millions of users identify health concerns more quickly, as such ubiquitous devices may make users seek treatment earlier, may make those previously unaware of issue, and empower users with more information in regards to their health.
A broad swath of new companies have begun investing in digital healthcare opportunities including ride sharing apps and virtual home assistants which may not be fully versed in navigating regulatory landscapes, as pointed out by agency leaders, adding the FDA has a digital healthcare action plan that was unveiled in 2017 aimed at streamlining approvals for software posing lower risk than traditional devices.
The new inclusion of Apple smartwatch of both fall detection and ECG support suggest that it is most targeted to older generations of user, portraying it as more than just a must have for tech focused millennials. To add to this the FDA letter classifying the device as a Class II device dated Sept.11.2018 states that the ECG app is not intended for use by those under the age 22.
The app to unlock ECG functionally will be available to USA consumers later in 2018, it uses built in electrodes and heart rate sensors. As users touch and hold the side of the device it sends electric current through the chest to the opposite hand, after 30 seconds the device measures heart rhythms, classifies them, and alerts users of any signs of atrial fibrillation. In the background for irregularities heartbeats are intermittently analyzed for whether it falls or exceeds specified thresholds, data recordings and/or noted symptoms are stored in the smartwatch health app in PDF which can be shared with physicians.
There are other ECG capable watches available such as the FDA cleared attachment AliveCor KardiaBand. Earlier in 2018 AliveCor and the Mayo Clinic showed that a trained AI network could help identify patients at risk for arrhythmia and sudden death using data from portable ECG devices.
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