Apple Watch can monitor heart rhythms with FDA approval

September 18, 2018
by Thomas Dworetzky, Contributing Reporter
The new Apple Watch Series 4 can look into your heart – or at least monitor its rhythms, thanks to a pair of ECG apps that can work with it.

The FDA-approved electrocardiogram apps, also given the thumbs up by the American Heart Association, can pick up atrial fibrillation, unusually slow or unusually fast heart rates and record the data for use by clinicians. And if you fall and can't get up, the phone can know that and even make an emergency call.

“The ability to access health data from an on-demand electrocardiogram or ECG is game-changing, especially when evaluating atrial fibrillation – an irregular and often rapid heart rate that can increase a person’s risk of stroke, heart failure and other heart-related complications,” Ivor Benjamin, president of the American Heart Association said.

Apple was even more effusive, with its COO Jeff Williams telling the audience at the news conference at the company's Cupertino HQ, “the Apple Watch has become an intelligent guardian for your health.”

The apps are not, however, a replacement for the doctor's ECG machine, so some care is needed.

“This will be, from what I see, a rhythm recording device,” American College of Cardiology president Dr. Michael Valentine told NBC News, adding that, “I would caution people who think you could determine other cardiac problems such as heart attacks from a wrist recorder.”

That said, the device has a big plus.

"There are many patients we see that have palpitations or rapid heart rates and we put a monitor on them and the patient returns to the office and states that you didn’t capture their symptoms when the monitor was on," Valentine said.

The device could also be helpful for between-visit monitoring of patients diagnosed with heart rhythm abnormalities, Dr. Lawrence Phillips, a cardiologist and assistant professor of medicine at New York University Langone Health, told the network.

"The second group of patients it could help would be those already diagnosed with a heart rhythm abnormality, and this could give information for follow-up," Phillips said.

“Health care products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health,” FDA commissioner Dr. Scott Gottlieb said in a statement.

“Due to the great promise of these technologies and the rapid pace of change, the FDA is working to modernize our regulatory approach to better enable and more efficiently spur innovation in this novel area, to improve the health and quality of life of consumers and patients.”

More news of wearable medical tech hit in February, when Empatica announced that its Embrace artificial intelligence-based smart watch received FDA clearance to monitor grand mal seizures and alert caregivers that help is needed.

“EEG's can't be used all day, every day like Embrace can, so EEGs miss a lot of important events that Embrace can catch,” Rosalind Picard, director of the Affective Computing Group and chief scientist at Empatica, told HCB News. “Embrace does not aim to replace the EEG. It gives complementary information, not the same information.”

Embrace uses advanced machine learning technology to identify the convulsive seizures. It’s different from other seizure detection systems in that it quantifies physiological changes in sympathetic nervous system activity.

According to Picard, her team worked for years on creating wearable stress and emotion sensors, and accidentally discovered they could track changes in the skin elicited by brain activity related to the most dangerous types of seizures.

The latest Apple 4 apps aren't the only wrist-based heart-monitors. AliveCor launched its Kardia Pro artificial intelligence platform for atrial fibrillation in the U.S. market in February, 2017.

The Kardia band lets Apple Watch users capture their ECG to detect normal sinus heart rhythms and atrial fibrillation (AFib). It was the first FDA-cleared medical device accessory for Apple Watch, according to a company statement.

“KardiaBand paired with SmartRhythm technology will be life-changing for people who are serious about heart health,” said Vic Gundotra, CEO, AliveCor at the time. “These capabilities will allow people to easily and discreetly check their heart rhythms when they may be abnormal, capturing essential information to help doctors identify the issue and inform a clear path of care to help manage AFib, a leading cause of stroke, and other serious conditions.”