Bruin Biometrics, a provider of biometric-sensor based medical devices, has received support from EU Scientific Community for its SEM (sub-epidermal moisture) scanner technology.
After two weeks of clinical briefings to more than 200 pressure ulcer experts in the EU, the company secured substantial concurrence on both the clinical validity of SEM and the clinical utility of BBI’s SEM scanner.
Bruin Biometrics Sales vice president Mark Bruns said: "From our post-briefing surveys, over 90% of the respondents drawn from the European Wound Management Association and European Pressure Ulcer Advisory Panel agree that SEM is a meaningful biomarker for early indication – up to 10 days before damage is visible on the skin – of pressure-induced tissue damage, acknowledging years of research led by Professor Barbara Bates-Jensen of UCLA.
"Slightly more than 40% of those surveyed provided responses. Of those, a substantial majority further agreed that our SEM Scanner can be used to assess pressure-induced tissue damage.
"We’re honored to have the support of the international community of pressure ulcer experts as we take the next steps to market this innovative device to wound management clinicians worldwide."
The company’ SEM scanner obtained CE Mark approval and the device is currently in full commercial launch in the EU. The scanner is yet to receive approval from the US Food and Drug Administration approval is not currently for sale in the US.