Apple took a big step toward turning its smartwatch into a medical device, adding new heart-monitoring and fall-detection applications that doctors say could help detect serious medical conditions but also trigger false alarms and unnecessary medical care.
The new electrocardiogram, or ECG, app carries a potentially big benefit: helping catch silent killers like a heart-rhythm disorder known as atrial fibrillation that is missed in many patients who don’t have symptoms.
About 2.7 million Americans and 34 million people world-wide are estimated to have atrial fibrillation, which can increase the risk of stroke. Standard ECG tests are typically given in doctor’s offices and hospitals, and involve attaching electrodes to a patient’s chest.
The Apple Watch ECG “could be beneficial to lots of patients” by picking up intermittent rhythm problems, said C. Michael Valentine, president of the American College of Cardiology and a cardiologist with Centra Medical Group in Lynchburg, Va.
Yet doctors also raised concerns about potential risks from relying on the app. Dr. John Mandrola, a cardiac electrophysiologist in Louisville, Ky., said the ECG feature could misdiagnose patients because of inaccurate readings, or lead to overtreatment of patients.
The watch may also detect cases of low-risk atrial fibrillation that don’t need to be treated, said Eric Topol, a cardiologist and director of the Scripps Translational Science Institute. This could lead to unnecessary prescriptions for blood thinners that carry bleeding risks, he said.
Dr. Topol said it isn’t clear whether the watch’s benefits in detecting asymptomatic cases outweigh such risks.
Due to the potential for serious impact, Apple asked the U.S. Food and Drug Administration to greenlight marketing of the ECG app and irregular-rhythm notification feature on the watch.
The agency granted the clearance on Tuesday, and said in a statement Wednesday that the features “may help millions of users identify health concerns more quickly.”
Yet the FDA also said the watch isn’t intended to provide a notification of every episode of irregular heart rhythm. The agency also said the ECG data displayed on the watch is for informational purposes only and isn’t intended to be interpreted by the user without consulting a health-care professional.
The Apple Watch can store readings and classifications from its ECG app in a PDF file that can be shared with physicians.
Last year, the FDA approved AliveCor Inc.’s KardiaBand, a sensor-equipped band that enabled Apple Watch to perform electrocardiograms. The new Apple Watch has the function built-in.
Other tech companies have been developing digital-health products. FDA Commissioner Scott Gottlieb said in a statement the agency wants to work with the developers to spur innovation, while adding that “as regulators, we will put patient safety at the forefront of what we do.”
For Apple, the addition of medical apps broadens the appeal of a device that has largely been marketed as a fitness and fashion product. The company is selling about 40 million watches a year, according to analysts, making it a small but growing contributor to the company’s revenue.
Apple has been taking steps to exploit the potential health benefits of its mobile devices. Last year, the company started the Apple Heart Study, testing whether the Apple Watch can detect heart irregularities. It also updated its mobile software this year to allow people to add medical records to their device.
The release of the new Apple Watch “really establishes the company’s increasing efforts to push the watch as a serious medical device,” Evercore ISI analyst Ross Muken said in a research note.
The watch also will can alert the user if their heart rate exceeds or falls below a specified threshold.
The new fall-detection technology on the watch uses a built-in accelerometer and gyroscope to identify when hard falls occur.
By analyzing wrist trajectory and impact acceleration, Apple Watch sends the user an alert on the watch face that says “It looks like you’ve taken a hard fall.” Users may dismiss the alert or initiate a call to emergency services.
If Apple Watch senses the wearer is immobile for 60 seconds after the notification, it call emergency services, and send a message along with location to emergency contacts, Apple said.