Cardiograph Watch
Apple Watch 4 is officially recognized as a medical gadget
Anna Kerman, XX2 century
Last week, the American Food and Drug Administration (FDA) allowed the use of "smart watches" Apple Watch Series 4 for taking an electrocardiogram (ECG) and detecting cardiac arrhythmias. Thus, this gadget will be the first ECG monitor that can be purchased without any restrictions.
Previously, the FDA has already worked with similar technologies. So, in 2014, the manufacturers of the KardiaBand ECG bracelet received permission from the Department (in fact, it was a strap for an Apple Watch with additional functions). But KardiaBand users, in order to get access to all the functions of the bracelet, needed to request a transcript of the first ECG from a certified cardiologist. In the app, this service cost $19.
The Apple Watch Series 4 has no such restrictions – users can independently study their own cardiograms and reports of heart rhythm disturbances. However, these functions are not intended for use by people under the age of 22 and those who have already been diagnosed with arrhythmia. In addition, there is no ECG or information about rhythm disturbances in the "native" Apple Watch Series 4 application yet – these options will appear in the next updates.
It should also be noted that the new Apple Watch has not received "approval" from the FDA. In the documents, we are talking only about "clearance". Approval is the "gold standard" of the FDA, but it is received only by products whose use is associated with serious health risks, for example, heart rate drivers. The procedure for obtaining a permit is much simpler – it is usually what manufacturers of safe medical devices go through.
However, Apple claims that ECG monitoring in the new Apple Watch has set a precedent for the appearance of a new item in the FDA classification. Although "smart watches" obviously refer to "harmless" gadgets, specifically the Apple Watch Series 4 has passed all the tests necessary to obtain approval (not permission) from the FDA.
FDA representative Scott Gottlieb expressed hope that Apple will become an example for other companies already working in the field of medical technologies or just planning to enter this market.
"The door is open for any manufacturer," Gottlieb said.
He also noted that doctors should develop a strategy for working with a new source of medical information.
"Users want to have access to information. I think it's up to professionals to make informed decisions regarding the handling of this information and advising users," concluded the FDA representative.
Doctors also spoke about the prospects of using the new Apple Watch for medical purposes. So, a post by an emergency doctor appeared on the popular resource Reddit, describing the limitations of a smartwatch as an ECG monitor. The author of the post emphasizes that the construction of the usual ECG requires the simultaneous connection of several electrodes – the only way to measure the electrical activity of the heart. There is only one electrode in the Apple Watch. In principle, it is sufficient to measure the speed and rhythm of the heart, as well as for screening (risk assessment) of atrial fibrillation. But to remove an ECG that has diagnostic (and not screening) value, patients will still have to go to medical institutions.
The FDA approval for the medical use of the Apple Watch is commented by Natalia Glazkova, CEO of the SENSE2BEAT project, researcher at the Skolkovo Institute of Science and Technology:
– It is important to understand that such technical solutions are currently advisory in nature. The last word and the diagnosis remains with the doctor.
A wearable device is just a data collection tool, a very good tool. Of course, watches and various patches have much more limited functionality in comparison with medical devices of a similar purpose; but at the same time they have a huge advantage in a long time interval. The data is collected in disproportionately large volumes, covering a variety of user activities throughout the day, allowing you to get a more complete picture of the state and cause-and-effect relationships.
At this stage, the Apple Watch solution is intended primarily for screening and primary diagnosis of arrhythmias.
Obtaining FDA medical certification for the Apple Watch platform is a breakthrough in the traditional field of healthcare and telemedicine. According to the protocols, the company is obliged to conduct comparative tests with the "gold standard", therefore, FDA clearance acts as a kind of guarantor of the accuracy and reliability of the method.
The potential of wearable medical devices is huge. Qualitative data on the condition and activity of the heart muscle, the daily physical activity of the user, introductory information about the characteristic symptoms (dizziness, shortness of breath, tingling in the chest); collected continuously for a long time – all this is "food for the mind", namely for artificial intelligence. Based on a large sample of such data, it will be possible to build qualitative predictive models and systems to support clinical decision-making.
But there are also difficulties. The main obstacle to automated ECG analysis is a lot of interference, as well as high noise level of the signal, characteristic of wearable electronics. To overcome these difficulties, our team develops noise filtering methods that do not require setting limits on ECG dynamics. Thanks to this, we hope to minimize the risk of distortion of conclusions and open the possibility of reliable automated diagnosis of cardiovascular diseases.
It is effective methods of processing big data and the extraction of a useful signal from its mixture with noise that can reduce the cost of electronics. This is extremely important in the context of creating new wearable biomedical devices that are useful for human health.
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