Sensor technology company Bruin Biometrics (BBI) has seen its SEM Scanner granted marketing authorisation from the Food and Drug Administration (FDA).
The device’s purpose is to alert clinicians to specific anatomical areas of a patient’s body at increased risk for developing pressure damage.
The SEM Scanner received European CE Mark approval in 2014 and Health Canada clearance in 2016 and is in full commercial use in Canada and the European Union including the UK, Belgium and Spain.
FDA granted marketing authorisation for the SEM Scanner under its de novo review process for novel low- to moderate-risk devices that are not substantially equivalent to an already legally marketed device.
Authorisation was based, in part, on data from a clinical study assessing performance of the SEM Scanner compared to visual skin assessment by nurses in 182 patients at risk for pressure ulcers at 12 hospitals and skilled nursing facilities in the U.S. and United Kingdom.
BBI CEO Martin Burns said: “Our singular objective is to reduce pressure injury incidence by helping clinicians make prevention real. Total prevention of avoidable pressure injuries is mathematically impossible under the current standard of care. Prevention success demands objective, early, anatomically specific data. For the first time, in the US, clinicians will have access to anatomically specific risk assessment data that can be gathered from increased risk patients in all care settings. We are optimistic of the impact these data will have on prevention strategies in the U.S.A.”
