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 information to be transmitted to a secured remote server, very much like other telehealth devices.
The stored information, which can be accessed by clinicians for analysis and intervention, can also be reviewed by patients, allowing them to receive educational and motivational content from clinicians.
The CHM device is designed specifically for use in the home, as the FDA Class II 501(k) summary explicitly states that the device is not intended for use in surgical rooms, intensive care units, intermediate or step-down units, or in emergency vehicles.
The 501(k) summary also notes that the device may be used in conjunction with several other supported patient monitoring devices, such as Ideal Life Inc.’s Blood Pressure Cuff and Glucose Monitor Model.
Written by Jason Oliva