Apple has landed a new FDA clearance for an updated version of its ECG feature, allowing the tool to add a category called A-Fib with high heart rate.
This comes a little over two years after Apple first landed a De Novo clearance for its first version of the ECG reading.
The latest version of the ECG feature will be available when the new software update rolls out. This second generation will expand the classification range all the way to 150 beats per minute. MobiHealthNews has learned the new classification has a 99.3% specificity rate and 98.5% sensitivity.
The feature can be found in the on-demand experience. As in the previous version, users can take a recording and see the wave form recorded. If a user has Atrial fibrillation and a heart rate that is between 100 and 150, the feature will give users this new classification about atrial fibrillation with high heart rate and suggest they speak to their doctor about it.
WHY IT MATTERS
According to the CDC, heart disease is the leading cause of death in the United States, accounting for about one in four deaths. Atrial fibrillation is common in the U.S., impacting roughly 12.1 million people. Advanced age, high blood pressure and obesity are all common risk factors for the condition. Today tech companies like Apple are putting detection tools into consumer-grade wearables.
THE LARGER TREND
In 2018 Apple became the first consumer wearable company to roll out an ECG feature. Apple has teamed up with Stanford Medicine to conduct the Apple Heart Study, which explored the performance of the Apple Watch’s heart rate sensor and accompanying algorithm in detecting potential arrhythmias. In 2019 the pair reported that, while the notifications for atrial fibrillation are rare, they often coincide with ECG-confirmed atrial fibrillation.
However, not everyone has been a fan of the technology. A Mayo Clinic researcher wrote in the Journal of the American Medical Informatics Association that false positives could lead to unnecessary healthcare utilization.
Apple also came under fire earlier this week when AliveCor raised a patent lawsuit against them over the ECG feature. The suit argues that the tools included in the Apple Watch Series 4 and later devices infringe on three patents held by AliveCor, all of which focus on cardiac arrhythmia.
While Apple may have been the first consumer wearable to implement ECG, it isn’t the only one. In August, Fitbit revealed its new smartwatch with an ECG app. Additionally, in January, Withings unveiled its new smartwatch with ECG and Sp02 capabilities.