Xilas Receives FDA Clearance for TempTouch

Xilas Medical's TempTouch home infrared temperature probe has received 510(k) clearance from the FDA for the intermittent measurement and monitoring of human skin surface temperature in the home or clinic for use with people of all ages.

The monitoring device is a portable, noninvasive tool that diabetic patients use daily at home to monitor foot temperature fluctuations, which are indicative of pending foot problems. In diabetes, patient involvement to identify early warning signs of the disease process is imperative to reduce the incidence of complications and prevent morbidity. For people with this chronic disease, foot ulcers are one of the most common precursors to diabetes-related amputations.

The TempTouch was clinically tested in two trials sponsored by the NIH, and the studies found a tenfold reduction in foot ulcers for people using the device. As a result of these trials, the TempTouch has been proven to significantly reduce diabetic foot ulcers by providing patients with an early warning of inflammation, which occurs before an ulcer actually breaks the surface of the skin. Once the inflammation has been detected, patients in the trials were able to reduce activity levels to avoid more serious problems such as ulceration.