Today, our client, Xilas Medical, announced that its TempTouch® home infrared temperature probe has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). As a result, the TempTouch® is now commercially available in the United States.
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.
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.
This is a great step forward for our client. We are in the process of handling the media outreach to promote this very good, and positive news.