atrial fibrillation
Cardio Intelligence is now testing its latest AI for detecting paroxysmal atrial fibrillation.
The Agency has qualified Apple's atrial fibrillation history feature as a medical device development tool, allowing it to be used in clinical trials.
The Rhythm Evaluation for AntiCoagulaTion (REACT-AF) trial will study a "pill-in-pocket" method of stroke prevention for patients with atrial fibrillation. Some participants will monitor for AFib using an Apple Watch and take blood thinners as needed, instead of using the drug continuously.
The latest clearance is for an algorithm that characterizes how much atrial fibrillation a patient is experiencing over time.
The consumer app enables users to monitor their own heart rhythm round the clock.
The most common arrhythmias detected were premature atrial contractions, premature ventricular contractions, atrial tachycardia and nonsustained ventricular tachycardia.
The tech giant got both tools included in the Australian Register of Therapeutic Goods as Class IIa medical devices.
The company hopes that its more descriptive reports will distinguish the personal ECG offering from others limited to atrial fibrillation detection alone.
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The wearable combines medical-grade ECG and sleep breathing disturbance detection.