AgaMatrix, the medical device maker that launched the first iPhone-connected blood glucometer in the United States, has received U.S. Food and Drug Administration (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, an online resource for mobile health news. ”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, the new Health Manager is cleared for iPhone only. The application serves as a digital logbook, to which users can upload glucose information from a glucose meter using an AgaMatrix cable. It connects 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 is not available for purchase by consumers, partly because the company did not want to release a 30-pin cable in a market where Apple has phased it out, and the iPhone 5 version is not yet ready, Flaherty said. WaveSense app users have been entering glucometer data manually, he said.
Health Manager also mimics WaveSense by allowing users to enter information about carbohydrates and insulin in the app. Unlike the existing app, it includes a space for users to manually input weight information. This functionality, and the app’s more general name, suggest that AgaMatrix possibly might 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 for home use only, whereas the app was intended for both home and professional settings. Flaherty said that AgaMatrix aims to keep abreast of advances in technology; the company eventually plans to connect to Android devices.
AgaMatrix has not publically unveiled its newest app, and Flaherty declined to reveal a planned release date to MobiHealthNews.