FDA approval for Smartheart

The device transforms any smartphone into a personal Hospital-Grade ECG

Tel Aviv/Zurich, 25 June 2012 – SHL Telemedicine Ltd. (SIX Swiss Exchange: SHLTN),
a leading provider and developer of advanced personal telemedicine solutions,
announced today that it has received the approval of the American Food and Drug
Administration (the FDA) for the marketing of the SmartheartTM – an innovative device in
the Mobile Health field. The SmartheartTM has received already a marketing approval in
Europe according to the EU Medical Directive (the CE).

Through innovative technology developed by SHL, the SmartheartTM will enable any
individual who owns a smartphone (iPhone, Android and Blackberry) to perform a
Hospital-Grade ECG. The SmartheartTM enables the user to send the ECG results in real
time to the company’s telemedicine call center, to his personal physician or cardiologist,
upload it to his personal medical record or send it to the hospital for medical diagnosis.
The ECG results can be viewed and examined any time, on the smartphone, through
secured access. The SmartheartTM can be used by anyone, anytime, anywhere.

Erez Alroy, Co-CEO of SHL, commented: “We are proud to have received FDA
approval for our new revolutionary device. The Smartheart transforms any smartphone
into a Hospital-Grade ECG that allows the user to perform a quick and simple test, equal
in quality to a professional hospital ECG examination. We believe the SmartheartTM is a
technological breakthrough, positioning SHL at the forefront of the mHealth market,
opening up access to new target audiences, both in existing and new markets.”

Studies claim that mHealth technologies will revolutionize the health services market,
and that this market is expected to grow at significant rates, from US$0.5 billion in 2010
to over US$8 billion in 2018. The significant growth is already witnessed today, with
more than 60% of U.S. physicians using tablets and smartphones (suitable for the use
with SmartheartTM) as a part of their routine care.

In addition, global ECG devices market forecasts to reach US$4.1 billion by 2015 at a
CAGR of 9.7%. The SmartheartTM’s relevant market is 60% of the total market.

Facebook
Twitter
LinkedIn
Pinterest