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 This week, two Silicon Valley startups received a green-light from
the U.S. Food and Drug Administration for mobile applications that
monitor patients from home, a step forward for a nascent digital
health industry that has pressed for more clarity from the agency on
regulations.
AliveCor said it received the FDA's approval to detect serious heart
conditions in electrocardiogram (ECG) readings taken from a mobile
device. The company says its newly-approved algorithm can detect
atrial fibrillation, a form of cardiac arrhythmia that affects about
one in four adults over the age of 40. If its smartphone-compatible
heart-monitor device detects an abnormality, a physician could
intervene before the patient experiences a stroke or other
life-threatening event.
The device fits most smartphones and rests on a patient's finger or
chest to record an ECG.
"Atrial fibrillation is very hard to identify," said Euan Thomson,
AliveCor's chief executive. "A large group of people have it, but
don't know they have it."
Thomson said AliveCor can detect the condition and send the data to
a cardiologist for review. The company plans to incorporate this
algorithm into its application and make it available to consumers by
September.
In addition, startup Vital Connect received approval for a patch --
the "HealthPatch MD" -- that patients can attach to one of three
areas on their chest and view their own biometric data on a mobile
device.
Sensors embedded in the band-aid sized patch track heart rate, pulse
variability, respiratory rate, skin temperature, steps, "fall"
detection and more.
Valeska Schroeder, the company's vice president of product
management, said the medical device will hit the market in the
United States, and potentially also Canada and Europe, by the end of
the year. Patients need a prescription to buy the device.
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What is unique about Vital Connect is that it puts the data in
context, Schroeder explained. If a patient's heart rate spikes when
they are lying flat in bed, that is typically a worrisome sign. But
during exercise or a fall, it is a typical occurrence. If they opt
in, physicians get notified when their patients hit or exceed set
thresholds.
Vital Connect first hit the headlines when Apple poached one of its
senior executives, Ravi Narasimhan, as part of a larger effort to
hire talent from the medical field.
"We know we are working in a hot market," said Schroeder. "We know
other firms are interested in making related products."
These companies are taking different approaches, but they share the
goal of helping doctors track patients remotely and take steps to
prevent fatal outcomes. Data may also inform physicians about
whether their patients should schedule an in-person or emergency
room visit.
According to the Centers for Disease Control, 129.8 million people
visited the emergency room in 2010 and 13 percent of these visits
resulted in hospital readmission.
"By getting an intelligent device in the hands of a patient, we hope
to fulfill the vision for mobile health," said Thomson.
(Reporting By Christina Farr; editing by Andrew Hay)
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