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510k Approval for SMART Meter and App for Improving Diabetes Health

Wed, 08/20/2014 - 10:06am
PR Newswire

Gmate SMART connects with iPhone, iPad and iPod touch to deliver accurate and fast blood glucose results

Gmate SMART Philosys announces it has received U.S. Food and Drug Administration (FDA) 510K approval for the highly anticipated Gmate SMART Blood Glucose Monitoring System. The Gmate SMART meter is the size of a quarter and connects to the headphone jack on the iPhone, iPod touch or iPad, while using the free Gmate SMART app to deliver blood glucose test results, without the use of an adapter or Bluetooth device. The patent pending technology uses the operating system of the iOS device. For many people in the US, their iPhone, iPad or iPod touch has become an integral part of organizing their daily lives. The Gmate SMART app and meter integrates diabetes management directly to an iOS device while providing the following features: goal setting, graphing, and the ability to email or text blood glucose test results directly to your healthcare provider. This platform launches diabetes management into the future of better care, for a better you.

According to Center for Technology Innovation at Brookings, chronic diseases such as diabetes are costly and taxing on the current system. The use of mobile technologies that monitor patient symptoms and provide real-time treatment options have the potential to control costs, reduce errors, and improve the overall patient experience.1 Mike Tickle, Senior VP of Philosys' Sales adds that, "This is an exciting time for Philosys as we continue our efforts to be a technology leader for the diabetes mobile monitoring arena. The Gmate SMART will give our customers TeleHealth capabilities with the accuracy and quality they deserve at a cost effective price."

FDA 510K approval is an important milestone for Philosys in offering this technology to people with diabetes in the US, as well as globally. Philosys continues to move forward in their commitment to providing innovative health solutions to people with diabetes around the world.

1 Governance Studies The Brookings – Institution Improving Health Care through Mobile Medical Devices and Sensors

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