AliveCor challenges claim Apple Watch has the 1st over-the-counter ECG

Julie Spitzer - Print  | 

After Apple claimed its Apple Watch Series 4 would be the first FDA-cleared over-the-counter device with an electrocardiogram, AliveCor struck back, noting it obtained FDA clearance for similar products in 2014 and 2017, according to the Politico Morning eHealth newsletter.

In fact, the FDA cleared AliveCor's ECG accessory for the Apple Watch in late 2017. However, Apple argues it is the first company to deliver ECG readings directly to consumers, while AliveCor's products require physician review to unlock the device for the first time, according to CNBC's digital health reporter Christina Farr.

In response to Apple's announcement, AliveCor released plans for a 6-lead smartphone-compatible ECG reader, compared to the 1-lead Apple Watch, 9to5Mac reports. Standard ECG devices in hospitals use 12 leads to monitor patient heart data.

AliveCor says its system will be able to identify about 100 different diseases. The newest Apple Watch is only equipped to detect atrial fibrillation. According to AliveCor CEO Vic Gundotra, the 6-lead device "is, in theory, more accurate because there are more sensors picking up more information, which could be critical in saving lives," according to 9to5Mac.

AliveCor said it expects to obtain FDA clearance for the new product in 2019, Politico reports.

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