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In September, FDA granted de novo classification to two apps offered in the new Apple Watch Series 4, which the tech giant says have been “redesigned and re-engineered to help users stay connected, be more active, and manage their health in powerful new ways.”

But some in industry have raised concerns over potential favoritism by FDA in granting that clearance. In addition, medical experts also question the benefit of such apps.

Apple’s two new apps — one that creates an electrocardiogram similar to traditional electrocardiograms and one that analyzes pulse rate data to identify irregular heart rhythms — are cited by FDA as an example of tools that allow consumers and providers to supersede the traditional, physical constraints of healthcare delivery and make the most of the opportunities offered by mobile technology. The says it agency “worked closely with the company as they developed and tested these software products.”

“The clearance letters — posted the FDA’s website — are dated September 11. What’s remarkable about them is that Apple apparently filed its ECG clearance application on August 14, 2018, and the Irregular Rhythm Notification Feature application on August 9, 2018,” notes Bradley Merrill Thompson in an article titled, “FDA’s Dramatic Announcement of Apple’s Clearances: Is There a Level Playing Field at FDA?”

De novo requests, he says, are for the first-of-a-kind device, which typically take longer to clear than a follow-on device cleared through the 510(k) process.

“In thinking about Apple’s clearances, I am focused less on the duration of FDA’s review — because I don’t know what went on during the years before —and more on the timing of the two decisions,” he says. “While the two FDA letters are dated September 11, it looks to me like they might’ve been posted to the FDA website on September 12 — the exact same day as Apple’s event.”

Beyond the question of the timing of the clearance, though, is the clinical benefit of these types of apps. “Inappro­priate, broad screening can lead to further inappropriate testing, which can lead to misappropriation of resources and, at worst, can lead to invasive testing or harm to the patient than would have normally occurred,” says Northwestern Medicine cardiologist Susan Kim, MD.

“I’ve definitely had patients with whom access to this kind of monitoring almost creates more anxiety in some ways. In some cases, I’ve recommended putting their heart rate monitors away because their concern about every second or minute of their heart rate can interfere with their daily life and become out of proportion to the degree of their problem.”

Will the apps do more harm or more good for patients? Kim says she “would land somewhere in the middle.”

Sherrie Trigg

Editor and Director of Medical Content

Read Thompson’s article here.