Apple was a heartbeat away from being forced to delay unveiling the Apple Watch Series 4 last week

Apple was a heartbeat away from being forced to delay unveiling the Apple Watch Series 4 last week
Last Wednesday, Apple unveiled the new Apple Watch Series 4 during its "Gather round" event at the Steve Jobs theater in Apple Park. Besides the larger edge-to-edge screen found on the latest version of the timepiece, the new Apple Watch also comes with an electrocardiogram feature that nearly forced Apple to delay the introduction of the smartwatch. For as it turns out, the FDA didn't give the green light to the device's ECG capabilities until there were less than 24 hours remaining before the event was scheduled to take place.

No one would have been surprised if the heart rate monitor on Apple CEO Tim Cook's Apple Watch was spiking higher. According to a report published today, the FDA letters to Apple that essentially gave the Apple Watch's ECG feature the blessing of the agency, were dated September 11th; the unveiling took place on September 12th. With the letters in hand, Apple COO Jeff Williams was able to say at the event that the ECG technology on the timepiece had received de novo clearance from the FDA.

An electrocardiogram can detect irregular heartbeats, which is why offering it on a watch requires the approval of the FDA. According to today's report, the agency never looked at the ECG hardware before approving the feature. Based on the letters from the FDA to Apple, the thumbs up was based on examination of a pair of apps. The first app is named "Irregular Rhythm Notification Feature,"and alerts an Apple Watch wearer if his heartbeat shows a pattern seen in atrial fibrillation or another arrhythmia.

The second app studied by the FDA, "Electrocardiograph software for over-the-counter use" creates the ECG and displays an analysis that determines whether the ECG shows any signs of cardiac arrhythmias. The FDA makes it clear in its letters that the ECG on the Apple Watch is not intended to diagnose the wearer. The FDA also says that the feature should be used by those 22 years of age and older. The agency stresses that no "clinical action" should be taken based on the readings of the ECG on the Apple Watch "without consultation of a qualified healthcare professional." One worry that some have is that certain readings will make wearers nervous enough to make unnecessary visits to the doctor or the ER.

The FDA letters give Apple the approval to start marketing the ECG on the Apple Watch Series 4. Keep in mind that the ECG feature will not be on the watch when it launches on September 21st. ECG capabilities for the Apple Watch will be part of an OTA update for the timepiece that will be pushed out later this year. Meanwhile, if you can't wait, AliveCor has a Kardia Band for the Apple Watch that creates an ECG when the wearer puts his finger on a sensor pad found in the band.

source: FastCompany

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7 Comments

1. Phullofphil

Posts: 1761; Member since: Feb 10, 2009

That is a close one. But where is the charge pad

2. slim3bdo

Posts: 165; Member since: Jun 05, 2017

Last day clearness is a sign of bribery , 2nd it's been discussed all over medical sites that this watch might cause more harm than good due to overdiagnosis or misdiagnosis. Being able to do a one-lead ECG is definitely interesting, but does it always help? Here's a scenario. A 40-year-old runner starts feeling dizzy, lightheaded, and has chest pain. He worries but remembers that there is an ECG function on his watch. He proceeds to do the ECG which then reads "normal." Because of this he decides to continue to run. And might suffer CVA due to that wrong reassurance .

3. T12RYK

Posts: 849; Member since: Jun 10, 2011

Stop spouting nonsense!

4. DolmioMan

Posts: 313; Member since: Jan 08, 2018

Your scenario, the watch would definitely pick up an abnormality in that case, even if it didn’t nobody in that situation would start running again just because the watch says they’re fine.

6. slim3bdo

Posts: 165; Member since: Jun 05, 2017

And how did you know the watch would definitely pick up on that , it's a ONE LEAD ECG , many cases ONLY appear in 1 or 2 leads in 12 LEADs ECG , so 10 or 11 won't show any abnormalities . So please SHUT UP . This really annoying when doctors care about your health and the like of YOU care about defending your fruit company . And clearly didnt work in ER , cause if you did you will know that ppl tend to do so many stupid thing that they should know not to do , so again SHUT THE F*** UP

7. T12RYK

Posts: 849; Member since: Jun 10, 2011

Someones BUTTHURT! OOOOOOOOOOOOOOOOO!

5. darkkjedii

Posts: 30955; Member since: Feb 05, 2011

Glad they did, cause if they hadn't, the keynote woulda sucked big time. The watch was the only thing worth seeing...really.

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