company AFrame Digital landed FDA clearance to market its MobileCare Monitor as a Class II medical device, which
has had Class I approval since 2009, according to the press release.
The wristwatch-based health monitor can measure patient gait and provide real-time data, generating an alert to designated caregivers via a smartphone or other mobile device, the company said.
"Our corporate mission is to support the health and safety of elderly adults as they age in place, as well as post-acute patients across care settings and patients at risk for hospitalization," founder & CEO Cindy Crump said in prepared remarks. "We advance this mission by delivering the most advanced real-time telemonitoring solutions in the market."
The device, which links by Bluetooth to personal medical devices, offer a panic button for patients to call for help, according to the press release.
Company COO Bruce Wilson said the device is the 1st of its kind to deliver "continuous, real-time health and safety monitoring on an end-to-end FDA-cleared cloud-based medical data platform." Caregivers can customize alerts based on each patient’s individual care plan or wellness profile, and both patients and caregivers can enjoy enjoy greater independence and mobility, Wilson added.