Medical device manufacturer DexCom is busy developing an Apple Watch app, the company told the Wall Street Journal. The app will display information gathered from its diabetes glucose monitor on the screen, and may prove a boon for the millions of diabetes sufferers worldwide.
Wall Street Journal reporter Kate Linebaugh has seen a picture of the app; which converts data from a diabetes glucose monitor into a simple graph – all highly convenient. Moreover, DexCom has also developed a monitor that uses a hair-thin sensor placed under the skin to measure blood glucose levels every five minutes.
The Food and Drug Administration (FDA) has been scrutinising health-related software, but relaxed its stance somewhat following January, months after a group of software engineers developed a system for monitoring diabetes patients’ blood sugar over the Internet using a DexCom device – and spread that app without first securing the FDA’s approval, an act which neatly circumvented the guidelines, giving a tacit green light for developers.
The group’s effort challenged the slow pace of innovation and regulatory approval in the field. It also highlighted the growing role that Silicon Valley companies and software developers hope to have in monitoring and maintaining people’s health.
DexCom’s monitors will remain Class III devices, but software that helps display the data they produce on mobile devices or smartwatches now only needs to be registered with the FDA and doesn’t require prior marketing approval.
DexCom submitted an iPhone app for review at the FDA, which ultimately approved the app within a reasonable timeframe. However, with the FDA relaxing its health-app rules, it won’t have to go through the same procedure with the Apple Watch app.