Apple has it Apple Watch 4 at its event earlier this week, and apart from the obvious screen upgrade, the new smartwatch has added additional health features, including the ability to take an electrocardiogram (ECG) approved by the FDA. To get this approval, they funded a long-term search found it the ECG detection software of the smartwatch was able to identify a serious condition known as atrial fibrillation (AFib) in 98% of cases.
The Apple Watch 4 uses its pulse sensor to monitor the heart rate of the wearer. The ECG function specifically looks at heart rates that are too fast, too slow or too irregular – activity that is linked to AFib. If it detects such activity, it warns the wearer.
The Apple-sponsored study, submitted to the FDA, called the Apple Heart Study and made in collaboration with Stanford Medicine, started last November and completed earlier this month. It included 588 individuals – half had AFib, while the other half had healthy heart rates.
During the study, Apple Watches with a specific study app were able to identify more than 98% of patients who had AFib and more than 99% who were healthy. The study helped Apple get two FDA clearances by using data to show that the device was used safely.
The single sensor of the Apple Watch 4 would not be a substitute for the right medical procedure, as Quartz indicates. A medical protocol for ECGs typically requires confirming a dozen different "leads" that are placed over the patient's body to examine their cardiac activity. In the approval of the FDA letter (PDF), the agency required Apple to inform the users of its ECG software of the risks associated with erroneous arrhythmia detection and the dangers of misinterpretation or excessive dependency on the software.
The FDA considers the Apple Watch 4 to be a "Class II & # 39; risk device; For reference, pacemakers are & # 39; class III & # 39 ;.