Apple Adds Heart-Monitoring, Fall-Detection Features to Its Watch
September 12 2018 - 7:18PM
Dow Jones News
By Peter Loftus and Tripp Mickle
Apple Inc. 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 additions, which Apple revealed Wednesday, are a
prominent example of Silicon Valley's moves into medical
monitoring. Yet the technology's risks suggest the challenges of
broadening access to tests and data that have been limited to
doctors.
The latest version of the Apple Watch is equipped with
electrodes and sensors that turns it into an electrocardiogram able
to measure a heart's electrical activity and detect potentially
dangerous disorders.
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.
(END) Dow Jones Newswires
September 12, 2018 19:03 ET (23:03 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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