RTX Healthcare has announced that the U.S. Food and Drug Administration has issued a 510(k) Premarket Notification Clearance to the Company for the RTX3320 PSTN Wireless Telehealth Gateway, designed for home monitoring, e-health and remote disease management applications.
The device provides immediate benefits to patients by utilizing advanced wireless and Internet technologies, carefully implemented for seamless and automated operation with a minimum need for patient interaction to improve patient quality of life, convenience and compliance in their daily monitoring.
"The advantage of the Wireless Telehealth Gateway for patients and healthcare providers is its simplicity and reliability," said Chris Tubis, President and CEO, RTX America. "The Wireless Telehealth Gateway is the first and only FDA approved wireless connectivity device for remote patient monitoring, creating what has been a missing link between standard wireless patient monitors, currently available, and any electronic patient health record managed by a healthcare provider."
"The recent integration of the Wireless Telehealth Gateway solution into our suite of home monitoring telemedicine products has enabled us to package a non-invasive, practical solution with pricing suitable for any scalable remote patient monitoring program," said James R. King, Senior Systems Engineer, Healthcare Vision, Inc. "The Wireless Telehealth Gateway technology is dependable with simple configuration and deployment procedures. Most importantly, we have found that its hands-free operation does not introduce any disruption in the patient's daily measurement routine."
The Wireless Telehealth Gateway is a wireless Bluetooth-to-PSTN gateway designed for home use by patients. It is intended to be used in combination with a variety of patient monitors upon the prescription of a licensed physician or other authorized healthcare provider. Its purpose is to transmit selected medical information -- such as weight, blood pressure or blood glucose levels -- over a normal residential telephone line directly to the healthcare facility. The Wireless Telehealth Gateway is fully compliant with the Health Insurance Portability and Accountability Act (HIPAA) of 1996, thus ensuring protection of confidentiality and security of patient health data.
The Wireless Telehealth Gateway serves as the remote communications link between compatible patient monitors and the compatible healthcare facility at another location - which could be a physician office, disease management center, or other out-of-hospital caregiver facility.
The Wireless Telehealth Gateway is a "black box" device that is not connected to or operated by the patient. The device does not measure, interpret or make any decisions on the vital data it conveys. Rather, when the device has received the measured values, it stores the data and generates a call using the analog phone line, conveying the data to a remote facility.