A recently published article in the New York Times has suggested that the Series 4 Apple Watch, which comes equipped with an in-built electrocardiogram (ECG), should not be considered a medical device.
The Series 4 Apple Watch was released in September this year amongst much fanfare, with users praising the fitness-centric software update, watchOS 5, that was released almost simultaneously, with the device.
The software update brought in a host of new features for the previous iterations of the wrist-dwelling devices (except the 1st generation Apple Watch, which Apple has now ended support for) and was pre-installed on the Series 4.
The Apple Watch Series 4 also has a larger screen, louder speakers and up to two times faster performance than the previous generation. The devices are also being billed as one of the first over-the-counter ECG devices and have an inbuilt automatic fall detection function.
Upon release, the Apple Watch Series 4 received support from the American Heart Association (AHA), with the Association president making an appearance at the device launch. Dr Ivor Benjamin is AHA president and the director of the Cardiovascular Centre at the Medical College of Wisconsin. Dr Benjamin praised the lifesaving potential of technology and applauded Apple’s commitment to innovation and commitment to health.
It’s the newly introduced ECG feature that has brought the device a lot of attention among medical professionals and users alike. However, an article recently published in the New York Times advised restrain in referring to the Apple Watch Series 4 as a medical device.
The article ‘That New Apple Watch EKG Feature? There Are More Downs Than Ups’ was written by Indiana University School of Medicine paediatrics professor Dr. Aaron Carroll, and he went on to call into question the potential for both false positives and negative aspects of the newly released device.
While he did acknowledge the possible positives of the device, Carroll said, “just because something seems like a good idea doesn’t mean it is.”
Carroll ultimately criticises the potential for false-positive or false-negative test diagnosis that could result from using the Series 4 ECG function, adding that watch users could potentially be 'clogging' up an already stretched healthcare system by taking watch ECG results as a legitimate diagnosis of a problem.
Likewise, people who may need to see a healthcare professional for a legitimate undiagnosed health issue could fore-go a necessary medical check-up as a result of taking a watch ECG and the device perhaps indicating everything is fine.
This risk was also raised by the FDA when Apple submitted a De Novo request to the FDA for regulatory classification of the ECG app in early August. The FDA determined that for the uses of the ECG app outlined by Apple, the ECG app can be classified as class II.
A de novo submission is mainly aimed at device manufacturers who have a new product they are looking to seek FDA clearance or approval for. Entirely new devices are automatically considered to be Class III in the US. However, many new products are not high risk, this is why the FDA has the "de novo" process. Most companies filing a “de novo” submission will have a device that is deemed to be “novel” with no existing classification or predicate device on the market.
It’s important to clarify that the Apple watch hasn’t received FDA approval, just FDA clearance. FDA approval is reserved for Class III products or technologies that are deemed to be a higher risk but also carry a higher potential benefit to the user. As the Apple Watch has been given a Class II classification it isn’t eligible for FDA approval.
FDA Commissioner Scott Gottlieb issued a statement highlighting the administration’s efforts to keep pace with a healthcare and medical device industry that is increasingly seeing an advance in digital health-focused products and devices.
Gottlieb said, “With these advances has come a new swath of companies that are investing in these new opportunities. These firms may be new to health care products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas.
“A great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch. One app creates an electrocardiogram, similar to traditional electrocardiograms, to detect the presence of atrial fibrillation and regular heart rhythm, while the other app analyses pulse rate data to identify irregular heart rhythms suggestive of atrial fibrillation and notify the user.”
The FDA recently launched a pilot programme called the “Pre-Cert for Software Pilot,” the move is meant to allow companies to develop technologies more rapidly, while still maintaining some government oversight over those projects.
The programme allows for nine technology companies, including Apple, to get their products pre-cleared, rather than going through the FDA’s standard application and approval process. Effectively 'fast-tracking' medically and health features from these companies to market, faster than the previous standard route.
In his article, Carroll added that he believes that one of the major problems with the device is that the people who would benefit most are least likely to get it.
Carroll went on to say: “I happen to own an Apple Watch. I find the other functions useful and fun. I even enjoy aspects of the activity monitoring. But I’m under no illusion they will help me lose weight or exercise more or improve my heart health. I own one because I want it, not because I need it. That’s the same criterion you should use, too.”
Whilst Carroll wrote his article in response to the newly added ECG feature on Series 4 Apple Watches, there is already a third party Apple Watch band with a built in ECG function being sold under the brand name 'Kardiaband'. The band is priced at an initial cost of £199 and requires the user to purchase a premium membership for the accompanying Kardia app for £9.99/month or £99/year in order to use the device.
Kardiaband is compatible with previous versions of the Apple Watch, and the company states on the website product page that, "KardiaBand is a medical device that is regulated per federal and international regulations."
Dr. Carroll position in his NYT article is possibly right - we shouldn't call the Series 4 Apple Watch a medical device, but perhaps the potential benefits these health-driven devices bring are an ultimately positive aspect and an argument for more people to use them. Perhaps in the not too distant future these sort of healthtech devices will be a real aid to healthcare professionals and patients alike.
Dr. Aaron Carroll currently serves as a research mentor at the Indiana University School of Medicine, his faculty profile page is here
You can read the FDA's review of Apple's de novo request here