Apple barely got FDA approval for the 4’s ECG in time for the unveiling last week

It is highly likely that members of the company's team woke up on the day before Apple 's splash event last week. Because there is a possibility of taking an electrocardiogram, it seems that it has not received the indispensable green light from the Food and Drug Administration within 24 hours before presentation.

it depends A fast society Writer Mark Sullivan apparently heard stories of Apple employees about the nearby Steve Jobs Theater after the event. "When I realized Apple's FDA application documents go back to September 11, I understood the anxieties of humans well," Mark wrote in online articles. "Apple's event was September 12"

Jeff Williams, Apple 's Chief Operating Officer (COO) told those who gathered that the ECG function embedded in the system got FDA clearance in the whole event. This is a sort of designation that the company has become different from other products on the market, according to Mark 's notes, Jeff can not express it, and the official government has a new function It seems that it was placed behind. I did not come on the eve.

Last week the Food and Drug Administration (FDA) 's Chairman of Scott Gottlieb, Dr. Jeff Shuren, Director of Device and Radiation Health Center, said that FDA "closely cooperates with Apple, You can send a copy of the 11th letter from Apple to Apple, which explains exactly how the company can sell the news.

As I remind you, once 4 is released on Friday, I can not receive ECG right away. This feature will be added in software update later this year. On the other hand, FDA approval has helped remove the major hurdle with Apple and inform the general public that it wishes.

According to FDA letters, the agency did not look at the material itself. Like the mark, only notification functions and applications. Fastco piece.

The first application, called "irregular rhythm notification function", can check Apple's heart rate and send a notification when it detects a pattern suggesting atrial fibrillation or other arrhythmia.FDA Electrocardiogram software For use at storefront, create an electrocardiogram and analyze whether it shows signs.

© BGR

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