AFrame Digital, a Reston, Va.-based maker of telemonitoring technology, has received 510(k) clearance from the FDA to sell its MobileCare Monitor as a Class II medical device in the US. The company has had less-stringent Class I approval for its flagship monitoring product since 2009.
MobileCare Monitor is a wristwatch-like device that offers continuous, real-time monitoring for seniors, people with chronic diseases and others who might have high health and safety risks. The monitor links by Bluetooth to personal medical devices, measures patient gait, automatically detects falls and offers a panic button for wearers to summon help.
In case of a fall or an abnormal reading, the system sends an alert to designated caregivers via a smartphone or other mobile device. Patients and their caregivers also can view data in real time through a Web-based portal, featuring dashboards and drill-down decision trees.
The monitoring platform is intended to support the Program of All-inclusive Care for the Elderly (PACE) model of caring for older adults, according to the company. “Telemonitoring is increasingly important for health providers, accountable care organizations and PACE programs as they transition to performance-based models of payment and patient-centric models of care,” Jill DeGraff Thorpe, AFrame Digital’s VP for strategic initiatives, explains in a press release.
“A benefit of MobileCare Monitor is that it places a virtual safety net under individuals as they go about their daily activities. Not only do they enjoy greater independence and mobility, their formal or informal caregivers do too, including members of their family,” adds AFrame Digital COO Bruce Wilson. “Also, it successfully leverages technology to enable unparalleled personalized support, since caregivers can customize alerts based on each patient’s individual care plan or wellness profile.”