Doctor and Medical Device Company Take Issue With Apple’s ECG Claims

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Regarding Apple’s claims of 98% accuracy when detecting aFib (Atrial Fibrillation), Dr. Venkatesh Murthy, a cardiologist from the University of Michigan had this to say to Health News Review:

Neither of these sets of data have been published or peer-reviewed … In both of these data sets, researchers knew who had AFib. The numbers will change significantly when tested on a large population of people.
“The big problem with this conclusion is that this population has a prevalence of AFib that is probably 100-fold larger than Apple’s target market,” Murthy said. “This is not good. However, the major caveat here is that we are still lacking most of the information needed to be sure how this experiment was done, so we really are just guessing.”

I can understand his concern. It’s jarring, especially in the medical community, when a big-name tech company that’s never made mainstream medical devices before comes out and says they’ve added this medical functionality to their product and it’s 98% accurate.

The onus should be on Apple to provide the study data and prove that claim.

Just as well, medical device company AliveCor had some beef with Apple when it said it was the first OTC (over-the-counter) device to receive FDA clearance, a claim they believe should rest squarely on their KardiaBand. Unfortunately they failed to consider the fact that the KardiaBand is not a smart watch, nor a single purpose device at all. The KardiaBand is entirely useless without an Apple Watch, itself; one cannot buy a KardiaBand alone and expect to be able to monitor heart rhythm. Therefore, while it technically is the first OTC product, it is not the first device. The article in Cardio Brief even calls it an “accessory.”

The distinction is there for those who bother to look.

Spending a few moments reading some of its reviews on Amazon, the KardiaBand doesn’t seem to be faring too well with consumers, running with a 2.5/5 star rating.

Now, their new product is a much more substantial reader that can detect up to 100 different diseases. There isn’t much info on this new device besides the fact that it’ll have 6 leads which should be more accurate in measurement gathering. We don’t even have a name yet and certainly not a price. I wouldn’t be surprised if it landed in the same $400-500 price range as the Watch itself.

For most consumers that want a watch, this won’t matter. Do you pick the dedicated device that’s likely to be expensive and still buy a Watch that does almost the same thing? Probably not. Those who have actual heart problems won’t rely on the Watch for a diagnosis. AliveCor should understand that. If I had to guess, AliveCor took the defensive position because they saw Apple build into the Watch something they spent a lot of time on and wanted to become a decent slice of the Watch band market. Now, their band has no purpose and the announcement of their dedicated device so early screams “don’t forget about us, we’re relevant, too!”