We all remember that the presentation of the Apple special attention was paid to the smart Watch Apple Watch 4. Their feature is the sensor, which can remove the electrocardiogram (EKG) right on the spot. And separately it was stated that the new product is certified by the FDA — Management on sanitary inspection behind quality of foodstuff and medicines in the United States. And here came the questions.
Twitter user Adam Masina argues that it is not. There is a difference between approved (“approved”) and cleared (“the product meets the approved quality standards”). Apple Watch 4 true second. Simply put, smart watches can remove the ECG and show the data. However, they cannot be relied upon in case of health problems.
A thread on what it means that the FDA “cleared” the Apple Watch new EKG feature. First, here is FDA’s “clearance” letter if you want to read the full regulatory info: https://t.co/qu8CS54tUQ
— Adam Masin (@AdamMasinEsq) 12 Sep 2018
The FDA say that Apple ESD analyzes the data about heart rate. This allows you to identify even the smallest deviations in the heart rhythm, which can be a sign of atrial fibrillation. But to put a diagnosis on the basis of this information it is impossible.
On the official FDA website clearly States that the Apple Watch 4 is not a substitute for a full EKG. Function not tested on people under 22 years old. Finally, the Apple of ESD is not suitable for those who have previously found the atrial fibrillation. And Yes, the readings need only be removed in complete tranquility.
Of course, this does not mean that Apple intends lied. Many medical devices have the status “cleared by FDA” and not “approved”, that does not prevent their use in clinics. It is important to understand that the Apple Watch 4 can not replace specialized equipment. Also note that while the function of the ECG will only work in the States, and at the time of market entry, the ECG sensor, the clock will shut off. It activate later.
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