Wireless MedCARE Receives FDA Clearance of VivaTRAK™
FDA Clearance follows clinical evaluation at Medical Facilities of America; Wireless MedCARE preparing to offer service to long-term care market.
Roanoke, VA (PRWEB) August 18, 2010
Wireless MedCARE, LLC (http://www. wirelessmedcare. com) today announced it has received FDA 510(k) clearance to market its VivaTRAK™ sensor assisted care system.
VivaTRAK improves patient care while increasing operational efficiency and documentation of care activities associated with preventable conditions such as pressure ulcers and falls.
VivaTRAK is a complete system that monitors the activity of patients and their caregivers in nursing homes. The system ensures that care tasks are completed on time and documented in healthcare records for quality assurance, reimbursement and liability-risk mitigation purposes. It is a patient-focused and sensor-assisted care system that uses a patented fiber optic sensor to monitor a patient’s activity while in bed, processes this data in a proprietary data server, provides the appropriate notifications, and reports to the nursing staff – and then verifies their response to record that care was actually delivered.
“Since founding the company four years ago our focus has been on delivering to the healthcare market an innovative system that addresses quality of care and operational efficiency problems,” said Dan Wrappe the CEO of Wireless MedCARE. “This FDA 510(k) clearance of the VivaTRAK sensor assisted care system validates that the vision for the company is now reality. This milestone could not have been achieved without the support of our collaborative partners, employees, and investors. Now, we look forward to market entry.”
The 510(k) included data from a successful clinical evaluation at the Raleigh Court Healthcare Center operated by Medical Facilities of America, Inc. (MFA). The clinical evaluation was conducted with oversight by the Institutional Review Board of the Carilion Clinic located in Roanoke, Va.
“In an environment of shrinking revenue from government programs, the long-term care industry needs better tools,” said Keith Helmer, chief operating officer of MFA. “Our company has been pleased to assist WMC in shaping the system feature set and view VivaTRAK as an innovation in healthcare delivery.”
Wireless MedCARE is preparing to launch the VivaTRAK solution as a service in the fourth quarter of 2010. The system includes patented sensor technology for which the company holds the exclusive license (U. S. patents 7,189,958 and 7,196,317).
About Wireless MedCARE, LLC
Wireless MedCARE, LLC is a privately funded, early-stage company applying advanced wireless, sensor and information technology to healthcare. The company offers sensor assisted care systems with a strong emphasis on web-enabled and wireless technologies. To learn more, visit: http://www. wirelessmedcare. com (http://www. wirelessmedcare. com).
# # #
