ECG feature on Apple Watch Series 4 might not get approval in the U.K. for years
by Alan Friedman / Sep 27, 2018, 8:18 PM
A few days ago, we told you that it took a last second letter sent by the FDA to Apple to keep the Apple Watch Series 4 from being a no show at the September 12th "Gather round" event. In the letter, the FDA approved the ECG feature on the timepiece. The electrocardiogram can help detect irregular heart rhythms, making it an important personal health tool along with the heart rate monitor on the watch.
Apple Watch, because it uses only one lead compared to the 12 leads used on a standard ECG test performed in a Doctor's office. Despite that, the ECG feature on the smartwatch did have a 98% accuracy rate in detecting AFib in one test (20 million patients worldwide have this serious condition). Still, the FDA gave its blessing with the warning that no clinical action be taken on the basis of the Apple Watch's ECG "without consultation of a qualified healthcare professional." In the U.S. the feature will be enabled following an OTA update later this year.There have been some concerns about the ECG on the
In the U.K., Apple Watch Series 4 owners might end up waiting years before the ECG feature shows up on their wearable device. Approval there requires approval from the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA would have to examine documents provided by Apple and feel assured that the electrocardiogram feature is not only effective, but is also reliable. Apple might also be asked to repeat a clinical study. While Apple has done this already, the MHRA likes to know in advance when such a test is being run. 60 days prior to the start of the clinical test, Apple would have to file its intentions with the agency. A brand new clinical trial could take years.
Since the U.K. is still in the EU for now, there is a workaround. Apple could file with a similar regulatory agency from another EU country, like Germany. The restrictions are not as onerous in that country, according to a German cardiologist. The German Doctor says that approval in that country could come quickly. If Apple were to get approval from the German healthcare agency, it would have approval from all EU countries, the U.K. included.
Posts: 30786; Member since: Feb 05, 2011
Take care of your health as best you can guys. Health is truly wealth.
posted on Sep 27, 2018, 8:24 PM 2
Posts: 1564; Member since: Jan 05, 2018
Time is your most valuable asset.
posted on Sep 28, 2018, 12:06 AM 0
Posts: 1740; Member since: Feb 10, 2009
Amazing nobody’s on here to bash Apple for not doing that but I’m actually kind a happy because I’m sick of seeing it. Maybe it’s because no other brand out there does it yet. Literally I see written crickets. But on a serious note the ways the United States approved it I think should not be a problem at all that is perfect it’s not really a medical device but a early warning system that possibly could help you save your life so I think it’s not just a gimmick it’s pretty cool
posted on Sep 27, 2018, 8:29 PM 0
Posts: 3092; Member since: Apr 15, 2016
How can it pass FDA with "unfinished" software? Why did they need to delay this feature it several months before releasing to public? Did it still need more calibration?
posted on Sep 27, 2018, 10:52 PM 1
Posts: 6452; Member since: Jul 11, 2012
They got a letter from the FDA 'at the last second'. Not hard to figure out 'how' that was accomplished. This thing obviously isn't medical grade equipment, but if helps in the slightest way and gives some peace of mind it's a good thing.
posted on Sep 28, 2018, 12:07 AM 0
Posts: 1373; Member since: Mar 16, 2017
"The Apple Watch does not have FDA Approval The Apple watch has FDA Clearance, meaning it's "substantially equivalent to (similar) another legally marketed device." It's a tier lower than full FDA Approval, which would be much more rigorous testing." The above is a quote from another forum and explains the "approval" a bit better.
posted on Sep 28, 2018, 1:33 AM 1
Posts: 2694; Member since: Nov 09, 2015
Sure, a proper ECG machine has 12 electrodes but... 1 electrode is better than no electrodes! That's what Mathematics suggest. Oh well...
posted on Sep 27, 2018, 10:59 PM 0
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