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."