AgaMatrix, the medical device maker that launched the first iPhone-connected blood glucometer in the United States, has received FDA 510(k) clearance for a cloud-connected app called AgaMatrix Health Manager, according to an FDA clearance document.
"The big differentiation with this version is it now has cloud connectivity, so we can connect more broadly," Joe Flaherty, Senior Manager of Strategic Marketing for AgaMatrix, said when contacted by MobiHealthNews. "Patients can share information wherever they want and can share it with their doctors and their caregiver."
Like AgaMatrix's existing app, the WaveSense Diabetes Manager, Health Manager is cleared for iPhone only. The application will serve as a digital logbook, to which users can upload glucose information from a glucose meter using an AgaMatrix cable. It will connect to both the Presto and Jazz glucose meters from AgaMatrix, but not IGBStar, Sanofi's iPhone-connected glucometer device which AgaMatrix manufactures. The IGBStar app is not cloud-connected.
Although the AgaMatrix connector cable is FDA-cleared, it's not available for purchase by consumers, partly because the company didn't want to release a 30-pin cable in a market where Apple has phased it out, and the iPhone 5 version isn't ready, according to Flaherty. Users of the existing WaveSense app have been entering glucometer data manually, he said.
Like the WaveSense app, Health Manager allows users to enter information about carbohydrates and insulin in the app. Unlike the existing app, it will also include a space for users to manually input weight information. This functionality, and the app's more general name, suggest that AgaMatrix could possibly be branching out beyond diabetes.
"We know patients want information about weight and that obesity and diabetes are highly correlated," Flaherty said. "We're providing a tool that will capture the data they need and share it very efficiently."
The new app has over-the-counter clearance, but it is described as for home use only, whereas the app was intended for both home and professional settings. Flaherty said that AgaMatrix's mission is to maintain category leadership by getting out front of any advance in the technology. He said the company does plan to connect to Android devices eventually, something that very few companies, such as Glooko, can currently boast.
The company has not made an official announcement about the new app, and Flaherty declined to comment about a planned release date.