Sensor-based diagnostic products developer Bruin Biometrics (BBI) has commenced a multi-center and pivotal clinical study to assess performance of the SEM Scanner in detecting early-stage pressure ulcers.
Pressure ulcers are a common medical problem, which can cause pain, disfigurement, infection and death. They are also known as bedsores, pressure sores and decubitis ulcers.
SEM Scanner is a hand-held non-invasive device, which evaluates sub-epidermal moisture. It is also a biomarker which has been found to detect early-stage pressure ulcers as much as ten days earlier than visual observation.
In the trial, the company plans to recruit around 400 at-risk patients at ten sites in the US and the UK.
The sites comprise of acute care, nursing home and long-term rehabilitation institutions.
BBI said that the study brings it closer to an FDA review of the handheld scanner, which is expected to be launched in the US in early 2017.
Bruin Biometrics product vice president Rachael Lester said: "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."
Currently, SEM Scanner is marketed in the UK and Ireland, as well as recently approved for commercial use in Canada.