FDA gave clearance to the latest version of Apple watch for use in detection and notification of atrial fibrillation and other arrhythmias.
The device generates a single-lead electrocardiogram (ECG) without any special band or third-party add-on.
A user got to touch a finger to electrodes built into the crown and a new electrical heart rate sensor in the back crystal provides the other contact.
Alerts are sent when abnormal rhythms are detected or when heart rates go above or below preset thresholds. Recordings, classifications, and any noted symptoms also go into a PDF file that can be sent to physicians.
In clearing the Apple Watch device and its software application for over-the-counter heart rhythm detection, the FDA noted that these functions are "intended for informational use only." It shouldn't be interpreted or acted upon without consulting with a qualified healthcare professional, nor can it replace traditional methods of diagnosis or treatment.
The agency also cautioned that the ECG app is not intended for use by people under 22 years old or for those already diagnosed with atrial fibrillation.
On day one of it’s availability, it already claims saving a life. To one user's surprise, he received an AFib result, causing him to rush to the doctors, where he was indeed diagnosed with irregular heartbeat.
The doctor at the clinic told him, "You should buy Apple stock. This probably saved you. I read about this last night and thought we would see an upswing this week. I didn't expect it first thing this morning." The user then headed straight to the cardiologist where his A-Fib was again confirmed, and an ultrasound was taken, and future visits were determined for proper treatment.
Though it’s accuracy of proper detection has been placed between 40-60%, and has been approved for information use only, still it is going to find good takers who will monitor their rhythms regularly.
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