US-based Bruin Biometrics has obtained CE Mark approval in the EU to market its SEM scanner, a class IIA medical device intended to detect pressure ulcers before they show up on skin's surface.
The hand-held device is intended to detect localized tissue edema and pressure induced tissue damage that may result in the formation of pressure ulcers (also known as pressure sores, or decubitus ulcers) before damage becomes visible on the surface of the skin.
The point of care diagnostic tool measures increased fluid content within the skin and underlying tissue known as subepidermal moisture (SEM).
In clinical studies, the device has demonstrated the ability in identifying pressure-induced tissue damage, including pressure ulcers, up to ten days before damage becomes visible on the skin's surface.
According to Bruin Biometrics, early detection of pressure ulcers with its SEM scanner can lead to targeted interventions, reduced ulceration severity, and early recovery, as well as decreased hospital days.
In addition, the scanner also provides advantages over other diagnostic modalities including objective, evidence-based measurements; non-invasive, rapid results; clear risk assessment documentation; standardized patient assessment; and minimal technical skills for operation.
The SEM scanner, which can serve as a biophysical marker of inflammation indicative of impending skin damage and pressure ulcer formation, has been developed by the company in cooperation with University of California at Los Angeles.
Bruin Biometrics will officially introduce the SEM scanner at the upcoming MEDICA conference in Dusseldorf, Germany, from 20-23 November 2013.
