FDA clears Bruin Biometrics’ wireless device to detect bedsore risk

The FDA granted Bruin Biometrics marketing approval for a wireless, hand-held scanner that warns doctors that their patients are at risk of developing pressure ulcers, or bedsores. The device is the first of its kind that assesses risk before damage shows up on the skin surface. 

The current approach for managing pressure ulcers relies on judging a patient’s overall risk for developing pressure ulcers and then performing a subjective skin and tissue assessment. Problem is, neither method points doctors to areas of risk until pressure injuries are visible on the surface—at which point the tissue has already been damaged. 

“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, clinicians will have access to anatomically specific risk assessment data that can be gathered from increased risk patients in all care settings,” said Bruin Biometrics CEO Martin Burns, in a statement.  

The device objectively alerts physicians to specific areas of a patient’s body that are at increased risk for pressure damage—namely, the heels and the sacrum, a bone at the base of the spinal column—before damage is visible. This information could help doctors intervene earlier, warding off pressure ulcers before they break through the skin. The SEM Scanner is indicated for use as an add-on to standard of care when evaluating patients who are at higher risk of pressure ulcers. 

“The anatomically specific information combined with tailored preventive actions may ultimately translate into fewer pressure sores, decreased costs, increased quality of patient care, increased patient satisfaction and decreased risk for adverse events due to pressure ulcers such as in-hospital mortality, prolonged length of stay, discharge to an extended care facility rather than to the home, and infection,” said Ruth Bryant, Ph.D., a SEM Scanner study investigator and director of nursing research at Abbott Northwestern Hospital in Minneapolis. 

The SEM Scanner has been used in the European Union since 2014 and Canada since 2016. Bruin Biometrics has hired “sales leaders, implementation and education professionals” ahead of its U.S. launch. 

"Approximately 20 U.S. and EU professionals are scheduled to attend formal office and field-based training in the U.K. in mid-January 2019,” Burns said.