Is the new Apple Watch really a medical device?

Press reports have highlighted the Series 4 Apple Watch’s new FDA-cleared features and focussed on its use a potential medical device. Lu Rahman looks at what the product offers and is somewhat sceptical of its latest labelling.

When Apple made its first foray into the wearables market back in 2015, the world went a little bit crazy for the tiny device that offered the ability communicate as well as offering up a health and fitness companion at the same time.

“Apple Watch begins a new chapter in the way we relate to technology and we think our customers are going to love it,” said Tim Cook, Apple’s CEO. “We can’t wait for people to start wearing Apple Watch to easily access information that matters, to interact with the world, and to live a better day by being more aware of their daily activity than ever before.”

“Conceived, designed and developed as a singular product, Apple Watch merges hardware and software like never before,” said Jony Ive, Apple’s senior vice president of design. “In Apple Watch, we’ve created three beautifully curated collections with a software architecture that together enable unparalleled personalisation in a wearable device.”

Fast forward to 2018 and the Apple Watch had continued to evolve and is taking on a new role ­- as a medical device. According to its maker: “Apple Watch Series 4 with watchOS 5 brings advanced activity and communications features, along with revolutionary health capabilities, including a new accelerometer and gyroscope, which are able to detect hard falls, and an electrical heart rate sensor that can take an electrocardiogram (ECG) using the new ECG app, which has been granted a De Novo classification by the FDA.”

The Series 4 watch is arguably the company’s most health-conscious device to date, offering features that has seen the FDA clearing the product as a Class 2 medical device. The Verge, explains the De Novo classification via Jon Speer, the Greenlight Guru: “Historically, claiming something is “de novo” is a less common way of getting devices to market, but it’s becoming more popular, adds Speer, as we blend fitness gadgets with emerging technology. “We’re going to continue to see these wearable technologies cross over and become regulated as medical devices… Think about things that are indicators of your health: blood pressure, heart pressure, respiratory rate, maybe things like diabetes management. The possibilities seem endless.”

According to Fortune, Apple sold eight million Apple watches in the final quarter of 2017.

“We’re thrilled Apple Watch has become an essential part of people's lives,” said Jeff Williams, Apple’s chief operating officer. “The completely redesigned Apple Watch Series 4 continues to be an indispensable communication and fitness companion, and now with the addition of groundbreaking features, like fall detection and the first-ever ECG app offered directly to consumers, it also becomes an intelligent guardian for your health.”

The features are an advanced ECG for heart monitoring, and the capability to notify the user of an irregular heart rhythm. There are some provisos however, as you can’t use these functions unless you’re over 22, and the irregular heart rhythm capability is only designed for people who haven’t been diagnosed with atrial fibrillation.

One question I have - can this really be a medical device? Well Apple did its groundwork and in order to create a product that could identify irregular heart rhythms, it set up a study (albeit small, with 600 participants) with Stanford Medicine so that the technology could be fine-tuned and used to detect conditions such as atrial fibrillation.

The Class 2 classification highlights that the device will not fatally affect a user if it doesn’t work, unlike a Class 3 product. So the jury’s out on its usefulness as medical device. Clearly highlighting that a person has an irregular heart rhythm is valuable, however, those with a pre-existing condition would obviously need a more sophisticated product as this device is unsuitable.

In terms of monitoring trips and falls, again, this is a useful feature on the new watch. However, in the UK. There are a range of initiatives that the NHS is rolling out that cover this type of injury such as gyroscopes in the form of wearables that help measure an elderly person’s gait and which mean a physiotherapist can create an exercise programme that reduces the risk of a trip or fall.

While the Series 4 Apple Watch is a great device with new useful features, I’m not sure we’ll see healthcare professionals relying on its data anytime soon.