DexCom is designing an app that will enable Apple Watch to display readings from DexCom’s glucose monitor, according to Kate Linebaugh writing in The Wall Street Journal. She reports that the FDA in late January loosened its regulatory treatment of such apps—perhaps partly in response to a group of software engineers who developed a system—called NightScout—for monitoring their diabetic children’s glucose levels over the Internet.
Linebaugh reports that DexCom’s under-the-skin sensor, which measures glucose levels every five minutes, will remain a class III device—subject to the strictness level of regulatory scrutiny. In contrast, under the relaxed FDA rules, the app would need to be registered with the FDA but wouldn’t require advanced marketing approval.
Linebaugh writes, “Steve Pacelli, DexCom’s head of strategy, said the regulatory nod for the iPhone app came in January, much faster than the company expected.”
In the home healthcare realm, tension exists between consumer electronics makers and traditional medical device manufacturers. The latter pursue differentiation through proprietary software, experience three- to five-year development cycles, require high reliability, maintain security in accordance with HIPAA patient privacy mandates, and reach volumes of about 1000 to 1 million units per year. The consumer electronics companies—and groups like the NightScout team—pursue low costs, less-than-one-year development cycles, open-source software, moderate reliability and security, and high volumes. The FDA’s move with regard to the DexCom app seems to be seeking a middle ground.—Rick Nelson
