After years of coming close, Apple has officially broken into the medical device space.
The company announced Wednesday that it received Food and Drug Administration clearance to market its latest Apple Watch, which is capable of conducting an electrocardiogram to measure heart rhythm. The company also received clearance to alert people who may be at risk for atrial fibrillation, an irregular heartbeat that can lead to more serious health concerns, based on measurements the watch takes.
Theirs is the first electrocardiogram ever to be available over the counter, Apple’s COO Jeff Williams said. The Apple Watch Series 4 will cost at least $399.
Apple wasn’t the only one bragging about the move Wednesday. FDA Commissioner Scott Gottlieb also jumped in to tout his agency’s role in the clearance.
“Our message today is clear — we want software developers to create new, innovative technologies that can help consumers take control of their health,” he said in a press release. “The FDA worked closely with [Apple] company as they developed and tested these software products, which may help millions of users identify health concerns more quickly.”
People who have already been diagnosed with atrial fibrillation or who are under 22 years old should not be using these apps, according to the FDA’s classification order, posted online shortly after the announcement. It also isn’t intended to pick up on any other forms of irregular heart rhythms — and it isn’t guaranteed to pick up every time a person’s heartbeats are off.
For people who think they have heart palpitations, this new feature might be particularly useful. Getting an EKG when people are actually having symptoms is important in those cases, said Dr. Gregory Marcus, a cardiologist at UCSF Health. “This is a very handy way to allow that to happen.”
“We know that atrial fibrillation is an important cause of stroke and that people can be asymptomatic,” he said. But he warned that in one study, he and his colleagues found that among people who might have had atrial fibrillation who were not hospitalized, a different smartwatch was only able to correctly diagnose people about 67 percent of the time. (The statistics were much better when patients were in the controlled setting of the hospital.)
That smartwatch setting didn’t use the new Apple Watch — but still, Marcus said, “in my mind, the next appropriate step is to rigorously study this and not to feel like this is the stopping point.”
In the past, Apple has shied away from making specific medical claims or interpretations, even as it unveiled tools to measure health-related statistics like a person’s heart rate. For the most part, the company has focused far more on general, wellness-type data collection — like how much a person moves.
That simpler data collection has largely fallen into a kind of gray area that the FDA has explicitly said it will ignore for now — that is, it’s fallen into the zone where the agency is exercising “enforcement discretion.”
But the agency has always said it will regulate any smartphone or app that becomes a medical device itself — and it’s been especially clear that it will be regulating anything that deals with the way hearts behave and sound. That includes things like accessories that turn a phone into an ultrasound screen, a remote control for IV pumps and — of course — an EKG.
Apps like these, in the agency’s eyes, come with more potential for harm. People could misinterpret the data and stop taking their heart medications, cancel or make appointments with a cardiologist, or even dismiss the symptoms of a heart issue.
Apple has done testing and labeled the devices to mitigate these risks, the clearance documents note.
This clearance isn’t the first time that an Apple Watch app or accessory has received the FDA’s blessing; a third-party band designed to be used with the Apple Watch received clearance for heart rate monitoring in November.
The app’s hefty price tag could put it out of reach for some people who might benefit from its new features, said Vic Gundotra, the CEO of AliveCor, which produced the third-party wristband.
“Apple Watch is great for affluent people who are comfortable with the technology, but medical technology can’t succeed unless you can get it in the hands of the people who need it and can use it,” he said. “Millions of older people may struggle with the Apple Watch’s technology or its expense.”