AFrame Digital, a medical device manufacturer based in Reston, Virginia, received clearance from the United States Food and Drug Administration (FDA) for its MobileCare monitoring system. The Class II approval of the device follows Class I approval by the FDA in 2009.
According to a press release by the company, the MobileCare health monitor uses a specialized wireless wristwatch device to monitor patient gait. The device can transmit real-time data to caregivers or other healthcare providers through a smartphone, tablet or other mobile devices.
The Bluetooth-powered device includes a panic button and is designed to deliver "continuous, real-time health and safety monitoring on an end-to-end FDA-cleared cloud-based medical data platform." Caregivers will have the ability to generate custom alerts based on a patient’s wellness profile or individual care plan. This will give both caregivers and patients a higher level of independence.
Cindy Crump is CEO and founder of AFrame Digital. In prepared remarks, she stated, "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." She continued, "We advance this mission by delivering the most advanced real-time telemonitoring solutions in the market."
- Changing a Colorant in an Approved Medical Device, What Should I Know? - Webcast
- Reduce Risk! Control Costs! Get to Market Faster! The Customer Solution Centre is Your Pathway to Successful Device Development. - Webcast
- Innovating within Cost Constraints to Get More Bang for Your Buck - Webcast
- Conformal Coatings for Tomorrow’s Medical Technologies - Webcast
- ISO80369 Standards Bring Changes to Medical Device Companies - Webcast
- Automation in Machining - Webcast