Apple’s atrial fibrillation (AFib) historical past characteristic on Apple Watch has been qualified by the FDA below its Medical Machine Growth Instruments (MDDT) program, the primary digital well being know-how characteristic of its sort to take action.
Since 2022, Apple Watch has supported AFib Historical past, which permits customers recognized with atrial fibrillation to view an estimate of how regularly their coronary heart is in this kind of irregular rhythm.
The characteristic analyzes pulse charge knowledge collected by a photoplethysmography (PPG) sensor to determine episodes in step with AFib and gives the person with a retrospective estimate of AFib burden (a measure of the period of time spent in AFib throughout previous Apple Watch put on). Apple says the characteristic is meant for people aged 22 years or older who’ve been recognized with atrial fibrillation.
The AFib Historical past characteristic acquired FDA clearance in the USA simply previous to its announcement by Apple, after being validated in a scientific research. The MDDT program below which the characteristic was approved at present is the FDA’s methodology of qualifying instruments that medical machine sponsors can select to make use of within the growth and analysis of medical gadgets.
In keeping with the FDA, the Atrial Fibrillation Historical past characteristic is:
- The primary digital well being know-how certified below the MDDT program, offering a non-invasive technique to verify estimates of atrial fibrillation (AFib) burden inside scientific research.
- Designed for use as a biomarker check to assist consider estimates of AFib burden as a secondary effectiveness endpoint inside scientific research meant to judge the protection and effectiveness of cardiac ablation gadgets to deal with.
- Designed for use all through the scientific research, each earlier than and after cardiac ablation gadgets, to watch a research participant’s weekly estimate of AFib burden.
(Through MyHealthyApple.com.)
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