Bruin Biometrics (BBI LLC) announces the start of a multicenter clinical trial evaluating how well its handheld SEM Scanner detects early-stage pressure ulcers compared to the standard of care.
The study, which is seeking up to 400 patients at 10 sites in the United States and United Kingdom at risk for developing pressure ulcers, reportedly brings BBI closer to an FDA review of the product, according to the company in a media release.
It is hoped that the new study will replicate the results of an independent study conducted at Royal College of Surgeons Ireland in 2015 demonstrating that the SEM Scanner is able to accurately detect early-stage pressure ulcers up to 11 days ahead of clinical judgment, per the release.
“This clinical trial is an important step in bringing a technology that is revolutionizing detection and prevention of pressure ulcers to US clinicians and patients. We have seen outstanding results in the UK where several hospitals have been able to reduce hospital-acquired incidence to zero using the SEM Scanner,” says Rachael Lester, vice president of product at Bruin Biometrics, in the release.
The SEM Scanner is currently available in the United Kingdom and Ireland, and was recently approved for commercial use in Canada. BBI expects to launch the SEM Scanner in the United States early in 2017.
[Source(s): Bruin Biometrics LLC, PR Newswire]
