The Journal of mHealth Vol 1 Issue 1 (Feb 2014) | Page 12

Industry News

Samsung Receives
FDA Clearance for
S Health App
For the first time, Samsung has received FDA
510(k) clearance for its S Health app. The categorisation of the clearance as a cardiology
signal transmitter suggests that the clearance will allow S Health to interface with
additional connected medical devices in
the United States.
Samsung’s S Health app originally launched for Galaxy
S III users in the UK in the summer of 2012. At the
time, it received data from Lifescan’s OneTouch UltraMini/UltraEasy Blood Glucose Meter via a USB connection. It also worked with Omron’s blood pressure
monitors and one of its body composition scales via
Bluetooth, and similar devices from A&D.
That release never found its way to the US, possibly
because of FDA clearance concerns. S Health finally
launched in the US with the Galaxy S4, but rather than
connecting to third party medical devices, it relied on
manual entry and purported to connect to three devices
from Samsung: a weight scale, a heart rate strap, and a
wrist-worn activity tracker. Those devices have still not
been made available for purchase in the US, although
the weight scale and heart rate strap can be purchased in

Samsung’s UK
store.
“S Health peripherals, specifically the
Heart Rate Monitor Band
and Connected Weight
Scale, will be available before
the end of the year,” the company
told MobiHealthNews in an email last August. “Samsung is working on perfecting the S Band and will announce when we’re ready for its commercial launch.”
Meanwhile, Samsung has continued to work on the S
Health app in several ways. In August, the company
added gamified avatar characters to the Korean version
of the app. In October, Cigna and Samsung announced
a multi-year partnership to enhance the app with content from Cigna.
Samsung filed for clearance in July 2013. If FDA clearance is the factor that has held the company back from
launching the various UK device connectivity features
in the United States, this clearance could pave the way
for rapid changes for US Samsung customers. 

mHealth Alliance announces
move to South Africa
The international organisation,
composed of more than 300 organisations from 59 countries, has
announced a move to South Africa
in 2014 and a co-location with the
Johannesburg-based Praekelt Foundation, a long-standing leader in

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February 2014

the development of programs that
promote social well-being. Organisation officials say the move “reflects the alliance’s natural evolution
to engage in projects and initiatives
that focus on specific countries or
regions, while still maintaining the

powerful global voice it has cultivated through its relationship with
the UN Foundation.”
“We’re proud of the catalytic role
that the alliance has played in moving the mHealth, as well as the