Tag Archives: Apple Watch 4

My New Apple Watch 4 Is Nice: But It Won’t Record ECGs or Work With KardiaBand!

The skeptical cardiologist picked up an Apple Watch 4  at the Galleria Apple Store in St. Louis today.  The Apple employee who retrieved it told me that ECG recording capabilities were expected in the fall. Of course fall began today and it is not at all clear when, if ever, Apple will provide the software update to its AW4 that will provide ECG capabilities.

Fortunately, consumers already have the capability of  recording a medical grade single lead ECG with any Apple Watch 2 or 3-using the KardiaBand from AliveCor.

Apple has hubristically proclaimed the AW4 as the  ultimate guardian of our health and while setting it up I was asked if I wanted the watch to notify me if my heart rate dropped below 40 bpm for 10 minutes. Sure! Let’s see how irritating this feature will be.

 

 

After setting up the new watch I immediately attached my KardiaBand and installed the Kardia Apple Watch app.

I was able to open the Kardia app and it performed its normal SmartRhythm monitoring but when I tried to record an ECG, alas, nothing happened.

It appears that the KardiaBand does not work with the new Apple Watch 4. Yet.

I was informed by Ira Bahr at AliveCor that their “testing on AW4 is not yet complete. So at present, the device is not supported.”

Now I face a difficult decision-Do I wear my new AW4 with a non KardiaBand wrist band (and no ECG capability) or wear my old Apple Watch with the KardiaBand (and outstanding ECG capability.)

ACP

Apple’s Alternative Facts And The Giant Watch Restaurant Next Door To AliveCor

As I pointed out Friday,  Apple’s claim that the ECG sensor on their new Apple Watch 4  (available “later this year”) is  “the First ECG product offered over the counter directly to consumers” is totally bogus.

AliveCor’s Kardia mobile ECG device was approved by the FDA  for over the counter direct to consumer sales on February 10, 2014. Apple had to have known this as they worked with AliveCor to bring the first Apple Watch based ECG device to FDA approval in 2017.

I tried but failed to get AliveCor founder Dr. David Albert’s thoughts on Apple’s disinformation but Yahoo finance was able to speak to Vic Gundotra, the CEO of AliveCor:

Over at the headquarters of AliveCor, a startup based in Google’s hometown of Mountain View, they, too, were surprised by the announcement, CEO Vic Gundotra said in a phone interview on Thursday. Gundotra is a former Googler, widely known as the executive behind the Google+ social network.

Specifically, Gundotra says that his company was confused by Apple’s claims that the Series 4 will be the first over-the-counter ECG testing device for consumers. AliveCor is a 49-employee startup that makes over-the-counter ECG testing devices and software, including an FDA-cleared band for the Apple Watch, called KardiaBand, and a version that attaches to a smartphone, called Kardia.

Gundotra was also surprised by Apple’s claims of ECG primacy

“We were watching [the announcement], and we were surprised,” Gundotra said. “It was amazing, it was like us being on stage, with the thing we’ve been doing for 7 years,” referring to AliveCor’s product for detecting atrial fibrillation  (AFib), a tough-to-spot heart disorder that manifests as an irregular, often quick heart rate that can cause poor circulation.

“Although when they said they were first to go over-the-counter, we were surprised,” he continued. “Apple doesn’t like to admit they copy anyone, even in the smallest things. Their own version of alternative facts.”

One man’s alternative fact is another (less polite) man’s lie.

Gundotra apparently views Apple’s entry as a good thing

“We love that Apple is validating AFib; just wait until you see what AliveCor is going to do next,” he said. “We were a great restaurant in a remote section of town, and someone just opened a giant restaurant right next to us, bringing a lot more attention.”

And as I pointed out previously, the AliveCor mobile ECG device (not the Kardia Band) is significantly cheaper than an Apple Watch and has multiple studies showing its accuracy. Interestingly, Gundotra indicates AliveCor sales has increased after the Apple announcement,.

“Ours is $99, theirs is $399, our sales popped yesterday, big time,”

Antialternafactively Yours,

-ACP

The New Apple Watch 4: Cardiac Accuracy Unknown, “Game-Changing” Benefits Overblown

On February 10, 2014 AliveCor, Inc. announced that its heavily validated personal  mobile ECG monitor had received FDA over-the counter clearance. Previously the device, which allows recording of a single-lead ECG and, in conjunction with a free smart-phone app, can diagnose atrial fibrillation was only available by prescription.

Since 2013, I have been successfully using this device with my patients who have atrial fibrillation (and writing about it extensively)

Apple COO Jeff Williams standing in front of (presumably) an ECG obtained by Apple Watch 4. It’s OK quality (but smallish p waves). Is that the best they could do? Notice that it is making a diagnosis of sinus rhythm. This PDF can be mailed “to your doctor.”

I was shocked, therefore, to hear the COO of Apple, Jeff Williams, announce that Apple will be offering in its new Apple Watch 4  “the first ECG product offered over the counter directly to consumers.”

This seemed blatantly inaccurate as AliveCor’s device clearly preceded by 4 years Apple’s claim.

Furthermore, AliveCor’s Kardia Band which converts any Apple Watch into a single-lead ECG  (which I’ve written about here and here) has been available and providing the Apple Watch-based ECGs since November 30, 2017.

AliveCor has an outstanding website which documents in detail all the research studies done on their products (there are dozens and dozens of linked papers) and all of their press releases dating back to 2012. It also explains in detail how the product works.

The title of their November 30, 2017 release was  FDA Clears First Medical Device Accessory for Apple Watch®

AliveCor shortly thereafter (December 12, 2017) announced Smart Rhythm , an Apple Watch app that monitors your rhythm and alerts you if it thinks you are in atrial fibrillation. I’ve discussed Smart Rhythm here.

Apple’s Watch will tell you that you are not in atrial fibrillation. Given that we don’t know how accurate it is, should that be reassuring?

The new Apple Watch’s rhythm monitoring app sounds a lot like Smart Rhythm but without any of the documentation AliveCor has provided.

So, within 10 months of Alivecor providing the world with the first ever wearable ECG (and proven its accuracy in afib) Apple seems to have come out with a remarkably similar product.

The major difference between Apple and AliveCor is the total lack of any reviewable data on the accuracy of the Apple device. Yes, that’s right Apple has provided no studies and no data and we have no idea how accurate its ECG device is (or its monitoring algorithm).

For all we know, it could diagnose sinus rhythm with frequent APCS or PVCs consistently as atrial fibrillation, sending thousands of Watch 4 wearers into a panic and overloading the health care system with meaningless alerts.

Apple’s website claims

Apple Watch Series 4 is capable of generating an ECG similar to a single-lead electrocardiogram. It’s a momentous achievement for a wearable device that can provide critical real-time data for doctors and peace of mind for you.

Apple’s “momentous achievement” was actually achieved 10 months earlier by AliveCor and if its monitoring algorithm and ECG system are significantly worse than the proven AliveCor system they will be destroying the peace of mind of users.

Electrodes built into the Digital Crown and the sapphire back crystal allow sensing of cardiac electrical signals. Did Apple get this idea from AliveCor?

After describing the Apple Watch’s new health features, Jeff Williams introduced Ivor Benjamin, MD, the President of the American Heart Association. Benjamin proceeded to describe the new Apple Watch cardiac features as “game-changing”, noting that the AHA is committed to helping patients be “proactive.”

Does  Benjamin have access to the accuracy of the Apple Watch ECG sensor? If so, he and the AHA should immediately share it with the scientific community. If not, by endorsing this feature of the Watch he should be ashamed. Users need to know if he or the AHA was paid any money for this appearance. Also, we should demand to know if (as the prominent AHA logo suggested and news reports implied) the AHA is somehow endorsing the Apple Watch.

Frequent readers know I’m a huge Apple fan but this Apple Watch business makes me think something is rotten in the state of Apple.

Skeptically Yours,

-ACP