Aframe Digital Receives FDA Class II 510(k) Clearance for Mobilecare Monitor

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AFrame Digital can now market its MobileCare Monitor system as a Class II device. MobileCare Monitor places a virtual safety net under the elderly and patients managing chronic health issues allowing them to go about their daily activities with greater independence and mobility. Caregivers can make more informed medical decisions and customize alerts based on each patient's care plan or wellness needs.

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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.

AFrame Digital announced today that it received FDA 510(k) clearance to market its flagship MobileCare Monitor℠ system as a Class II device. Since 2009, MobileCare Monitor has been cleared as a Class I device.

AFrame Digital customers include health systems, rehabilitation centers and providers of PACE, home health and senior services. The MobileCare Monitor service offers a scalable, hosted platform for care professionals to support patients across the continuum of care. Someone wearing AFrame Digital’s wireless, wristwatch-based health monitor can press a button to request help. Also, if that person experiences a fall, or has a vital sign reading outside their personal baseline or target range, the system will generate an alert in real-time to caregivers through their mobile communications device of choice.

MobileCare Monitor also offers a patented method for non-intrusively and continuously gathering data about a person’s activity, which is combined with vital sign and gait data to create individualized baselines of wellness. Vital sign data is obtained wirelessly from Class II FDA-cleared devices such as Bluetooth-enabled glucometers, pulse oximeters, weight scales and blood pressure cuffs.

“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. We advance this mission by delivering the most advanced real-time telemonitoring solutions in the market,” states Cindy Crump, CEO and Founder of AFrame Digital.

According to AFrame Digital’s COO Bruce Wilson, “MobileCare Monitor is first in its class for delivering continuous, real-time health and safety monitoring on an end-to-end FDA-cleared cloud-based medical data platform. 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. 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.”

“Customers that have selected AFrame Digital after rigorous market evaluation tell us they value the simplicity and comprehensive feature set of MobileCare Monitor,” states Kelly Besecker, VP Sales and Marketing. “MobileCare Monitor makes health-related data accessible in real-time with easy-to-navigate dashboards and drill-down options so clinicians and caregivers can make better treatment decisions.”

“Healthcare providers are increasingly comfortable with telemonitoring because of the insight they gain into the health and wellness of their patients as they go about their daily activities. With telemonitoring, health professionals can assess independent confirming patient-related data as a cross-check for patient-reported data. Tele-monitoring 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,” says Jill DeGraff Thorpe, AFrame Digital VP for Strategic Initiatives.

About AFrame Digital, Inc.
AFrame Digital provides advanced telemonitoring solutions that protect the safety and health of patients and residents in hospital, long-term care, senior living and home settings. Its industry-leading FDA-cleared MobileCare Monitor℠ system provides continuous monitoring of seniors, patients managing chronic conditions and other at-risk individuals as they go about their daily activities, with real-time fall detection and proactive, exceptions-based status reports and alerts based on personalized wellness profiles to help caregivers quickly attend to or avert crises. AFrame Digital is the recipient of multiple industry awards, including the Cellular Technology Industry Association's Emerging Technology Award for Health and Wellness Solutions (Enterprise Class), the Northern Virginia Technology Council's Destination Innovation Award for Small Business and the Virginia Commonwealth Research Commercialization Fund.

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Kelly Besecker
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