Apple has unveiled its Apple Watch Series 4 and confirmed speculation that the new device will bring ECG features approved by the US Food and Drug Administration.
Apple Chief Operating Officer Jeff Williams said at an event on Wednesday in Cupertino the company has received FDA clearance for both an atrial fibrillation-detecting algorithm and an ECG that will be built into the new Apple Watch Series 4 when it becomes available on September 21.
Williams announced several other new health features including fall detection, which takes advantage of the device's new accelerometer and gyroscope.
"I’m also pleased to say we’ve received clearance from the FDA," Williams said.
"This is a De Novo clearance, so it’s the first of its kind. The irregular heart rhythm alert has also received FDA clearance. Both of these features will be available to US customers later this year and we’re working hard to bring them to customers around the world."
Healthacre IT News Australia sister site MobiHealthNews predicted in February of this year that an algorithm for detecting atrial fibrillation could be the Apple's first FDA-cleared product, and the company has received clearance for such an algorithm, likely using data from the recently-concluded Apple Heart Study to submit the application.
"Apple Watch can now screen your heart rhythm in the background and it sends you a notification if it detects an irregular rhythm that appears to be atrial fibrillation," Williams said.
"Now, it won’t catch every instance of a-fib but this is going to help a lot of people who didn’t realise they had an issue."
Williams also announced that the watch will alert users to low heart rates in addition to high ones. But the blockbuster news is the ECG, which is accomplished by adding electrodes to the digital crown and the back of the watch.
"In addition to an optical heart sensor there is a new, Apple-designed electrical heart sensor that allows you to take an electrocardiogram, or ECG, to share with your doctor, a momentous achievement for a wearable device," designer Johnny Ives said in a pre-recorded video played at the event.
"Placing your finger on the digital crown creates a closed circuit with electrodes on the back, providing data that the ECG app uses to analyse your heart rhythm."
It takes about 30 seconds for a user to take an ECG, which is then stored in Apple's Health app. This means, via Apple Health Records, some users will also be able to send readings directly to their doctors.
"It’s amazing the same watch that you wear every day to make phone calls and respond to messages can now take an ECG," Williams said.
Apple's addition of fall detection is likely to be overshadowed by the ECG news but is also an impressive achievement.
"It’s interesting, identifying a fall may seem like a straightforward problem but it requires a tremendous amount of data and analysis," Williams said.
"We collected data on thousands of people and captured data on real-world falls and we learned something. ... When you trip, your body will naturally pitch forward and your arms will go forward to brace yourself. However, if you slip, there’s a natural upward motion in the arms. These are motions Series 4 is ideally suited to recognise. With a new accelerator and gyroscope, the watch analyses wrist trajectory and impact acceleration to determine when a fall occurs. And from that it issues an alert."
When the watch detects the fall, it will give the user an opportunity to call an emergency contact. But if it detects that the user is immobile for one minute after the fall, it will automatically reach out to authorities using Apple's emergency alert system. It also sends a message to emergency contacts in that situation.
Originally published on the US edition of Healthcare IT News.
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