Egret Technologies' client today filed a Bluetooth LE-enabled medical device submission to the U.S. FDA. The device is based on a Nordic Semiconductor Ultra Lower Power (ULP) radio transceiver implementing the Bluetooth 4.0 protocol.   The device has a complimentary iPhone application and is for patient self-monitoring of a chronic disease.

This submission is coincident with the U.S. FDA issuing guidance on wireless medical devices through their final guidance document "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff".