Philosys receives FDA clearance for iPhone-connected glucometer

By: Aditi Pai | Aug 20, 2014        

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GmateNew York City-based medical device maker Philosys received FDA 510(k) clearance this week for its smartphone-connected glucose meter, Gmate Smart.

To use the Gmate Smart glucometer, users launch the device’s connected app, plug in their Gmate glucometer through the audio jack, insert a test strip into the glucometer, add a blood sample, and view results on the app. Gmate Smart’s app is only compatible with iOS devices.

With each test that a user takes, they can add notes to accompany the reading, including nutrition data, fitness data, or medication information. The app also offers a log so users can look back at old readings. Users can search through old readings by date or view charts of average blood glucose test results within one, seven, 14, 30 and 60-day periods.

Philosys has already started preorders on the device to retailers and insurance plans, Mike Tickle, senior VP of sales at Philosys told MobiHealthNews. He also said the device will likely be sold at different pricepoints, ranging from $8.95 to $19.95.

The glucometer received its CE Mark in August 2012. At the time, MobiHealthNews reported that Philosys was looking for a telecom company to partner with it to bring the device to market in Europe.

Moving forward, Philosys wants to bring the data into the cloud so patients can share data with caregivers and pharmacists.

A similar device, Sanofi’s iBGStar, which uses an iPhone’s dock connector to sync the glucometer received its first FDA 510(k) clearance in December 2011.

While Sanofi offers a glucometer that connects directly to the mobile, another company, Glooko, offers users a cable to connect some of the most popular off-the-shelf glucometers to a smartphone to view and record readings. The company announced its Android-compatible cable in October 2013, three years after it launched a cable for iOS devices.

Another device, made by LabStyle Innovations, called Dario, is still seeking FDA clearance. The company received its CE mark certification in September 2013 and this year Labstyle partnered with nutrition app maker FatSecret. With this partnership in place, Dario users can log food from FatSecret’s database, an important part of the routine for a person with diabetes.

  • VoyageMD

    The most important (and missing) aspect is what to do with the data? This looks like another example of representing data rather than being creative. As always we need a clinical trial to prove value.