The FDA has given the approval to RTX Healthcare to market its Wireless Telehealth Gateway product, designed for home monitoring, e-health, and remote disease management applications.

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.