Silicon Valley-based startup Glooko announced two new executive hires this week and that its MeterSync Cable and Logbook iOS app received Class II FDA Clearance 510(k). The company appointed Rick Atlinger, who previously served as a vice president at Intuit Health, as its first CEO. Glooko co-founder Yogen Dalal filled in as interim CEO since the startup’s founding. Altinger launched Intuit’s healthcare provider services and spearheaded the company’s acquisition of patient portal company, Medfusion in 2010. Dean Lucas, who previously worked at Doximity and Epocrates, also joined Glooko this week as the company’s VP of product development. Glooko, which enables 15 of the most popular off-the-shelf glucose meters to connect to the iPhone via the company’s Metersync Cable, had previously registered its device and app as a Class I device with the FDA. Altinger told MobiHealthNews that the FDA clearance cost the startup about $1 million. “I’ll be honest with you, we were on the ragged edge as a Class I device,” Altinger told MobiHealthNews. “I don’t think there will be any other comparable device like ours that registers as a Class I now that the FDA has come out with clearer guidelines. [As a Class I] you really can’t touch any data from a Class II medical device, and all glucose meters are Class II devices. I can’t speak for the FDA but from our perspective, if you are going to take the data out of that device and manipulate it in any way, shape, or fashion, you’ve got to get Class II clearance.” Now that Glooko is FDA cleared it can present blood glucose data in various charts and graphs in its app and enable users to manually track their food intake, activity levels and more. Altinger said that those annotations are what makes the information in the Glooko Logbook app valuable to clinicians and diabetes educators. The blood glucose data alone is not all that helpful, he said. The charting capabilities for Glooko’s app are still fairly simplistic: chart by time of day, chart by date, and chart by analysis of time of day.
