Published time: September 24, 2013 22:01
Doctor Antonella Tosti, Dermatologist University of Miami School of Medicine, uses an iphone as a dermatoscope as she examines Michael Casa Nova,12, for symptoms of skin cancer due to sun exposure (Joe Raedle/Getty Images/AFP)
The US Food and Drug Administration will begin regulating a heightened category of mobile applications that run on smartphones that will function as traditional medical devices.
The FDA said Monday it will focus on health apps that turn
smartphones into medical devices, such as a heart monitor or
blood pressure gauge, or serve as an accessory to an existing
device.
The agency said most wellness apps that are designed to help
people stay healthy don’t pose much risk if they malfunction and
thus won’t be federally regulated.
Industry analysts say about 17,000 medical apps, with
capabilities that range from calorie counters to ophthalmoscopes
that detect retinal detachment or glaucoma, are available.
More complex apps increasingly in development perform test and
functions traditionally done in a doctor’s office.
“Mobile apps have the potential to transform health care by
allowing doctors to diagnose patients with potentially
life-threatening conditions outside of traditional health care
settings, help consumers manage their own health and wellness,
and also gain access to useful information whenever and wherever
they need it,” Dr. Jeffrey Shuren, director of the FDA’s
Center for Devices and Radiological Health, said in an agency
statement.
FDA officials said Monday they have already approved 75 of these
“mobile medical applications,” including 25 in the last
year.
Some recent approved apps include the Gauss Pixel App, which
helps medicals professionals measure the amount of blood loss in
surgical procedures, and AliveCor, which turns a smartphone into
an electrocardiogram measuring heart rhythms. Patients can then
email the reading to their doctor for analysis.
Many of these tools can cost $100 or more, though sales data is
still limited.
Copyright: RT