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Medical Devices / Submissions and Approvals

Philosys' Gmate Smart System for Mobile Devices Nabs FDA Approval

Aug. 19, 2014
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South Korean devicemaker Philosys received FDA 510(k) clearance to market its mobile device-compatible Gmate Smart Blood Glucose Monitoring System in the U.S.

The quarter-sized meter connects to the iPhone, iPad or iPod touch via the headphone jack and delivers blood glucose test results using the company’s free Gmate Smart app, Philosys said Friday. Users can set goals, graph and chart glucose levels, and email or text blood glucose test results directly to a healthcare provider.

According to Philosys, the ability to monitor patient symptoms and provide real-time treatment options will be cost-effective, reduce errors and improve patient experience.

The patent-pending technology runs on the iOS operating system and does not require an adapter or Bluetooth technology, according to the company. — Kellen Owings

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