Xilas Medical, Inc. Receives 510k Clearance From FDA For Its TempTouch Home Temperature Monitoring Device
The TempTouch is an infrared thermometer intended 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, non-invasive tool, which 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.
"By preventing foot ulcers, we can prevent diabetes-related amputations which is a significant development for the millions of people who have diabetes," said Don Lawson, CEO of Xilas Medical, Inc. "More than 6 percent of Americans are diabetic, and many of them have a loss of sensation in their feet, which makes it difficult for them to feel inflammation or the beginnings of an ulcer. TempTouch(R) is a way for them to easily test for potential problems, and take action to prevent complications. Now that the TempTouch(R) is commercially available, millions of diabetic patients will be able to benefit from this product and improve their quality of life."
The TempTouch was clinically tested in two trials sponsored by the National Institutes of Health (NIH), and the studies found a ten-fold 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.