FDA Will Regulate Only Some Mobile Health Apps

The Food and Drug Administration (FDA) said last week that it would only regulate some of the growing numbers of mobile health apps, focusing specifically on those that could pose greater risks to patients. The agency intends to “exercise enforcement discretion,” according to a release, meaning it will not enforce requirements under the Federal Drug […]

FDA Clears Verizon Wireless Device for Home Health Use

Verizon Wireless recently received clearance from the Food and Drug Administration (FDA) for a mobile device intended for home health usage. Approved as a Class II medical device, the Verizon Wireless Converged Health Management Device (CHM) is a remote monitoring software solution that collects and stores biometric data from other physiological devices, allowing such health […]