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FDA Grants De Novo Authorization to Pressure Ulcer Risk Assessment Device

January 7, 2019


Bruin Biometrics, LLC has been granted U.S. Food and Drug Administration marketing authorization for the SEM Scanner, a wireless handheld device that is indicated for use as an adjunct to the standard of care when assessing patients who are at increased risk for pressure ulcers.

The SEM Scanner is the world’s first FDA-authorized device to objectively alert clinicians to specific anatomical areas of a patient’s body at increased risk for developing pressure damage. Patient risk assessments are performed with the SEM Scanner before visible damage manifests at the skin surface – a world and clinical first.

Current clinical decision making relies on assessing a patient’s overall risk for pressure ulcer development and then completing a subjective skin and tissue assessment. Both methods suffer from not being able to direct clinicians to where the risk is building until damage is visible at the skin’s surface. Once pressure injuries (also known as pressure ulcers, or bed sores) become visible on the skin’s surface, tissue damage has already occurred.

Elevated readings from the SEM Scanner provide objective clinical information that directs clinicians to heels and sacrums at risk of developing pressure ulcers, even before the damage is visible. These data can facilitate earlier, anatomically specific interventions designed to reverse the damaging effects of pressure and shear and prevent the pressure injuries from breaking through the skin.

Still the number one most reported patient safety harm in many U.S. states, pressure ulcer incidence has remained stubbornly persistent. More than 2.5 million people annually develop bed sores in the United States, including nearly one out of 10 patients in hospitals and almost one-third of patients in long-term acute care.

Bed sores can lead to pain, disfigurement, infection and complications such as sepsis, cellulitis, and MRSA. 60,000 Americans die each year from complications from pressure ulcers – an equivalent mortality rate to the opioid crisis — at an annual cost of up to $11.6 billion to the U.S. health care system. These injuries result from pressure and shear causing localized damage to the skin and underlying tissue, typically at areas of bony prominence, such as the heels and sacrum.

Outside the United States, clinicians have been using the SEM Scanner in conjunction with existing risk assessment tools since 2014. U.K. NHS and private providers have enjoyed and won numerous awards for innovation and patient safety, including the Health Service Journal’s Patient Safety Award for Innovation (2017) and the Journal of Wound Care‘s Most Innovative Product (2018) for their use of the SEM Scanner.

See Full Press Release at the Source: FDA Grants De Novo Marketing Authorization to First-of-its-Kind Device for Objectively Assessing Patients at Risk of Pressure Ulcers

Press Release by Bruin Biometrics LLC

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