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Stages of formation of bedsores.

FDA Grants Clearance to the First Device for Assessing the Risk of Pressure Ulcers

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Bruin Biometrics, a biotechnology company from California has been granted marketing authorization by U.S. Food and Drug Administration (FDA) for their SEM Scanner. This scanner assesses patients who are at the risk of pressure ulcers.

SEM Scanner is a wireless handheld device that can be used by clinicians. It is said to be the first FDA-authorized device to help to evaluate those bodily areas of patients which are at the risk of developing bedsores.

Pressure ulcers or bedsores are the wounds on the body due to prolonged pressure over the skin.

In January 2019, FDA has given the authorization to SEM Scanner under its De Novo assessment process. The authorization was based on the data collected from a clinical study.

This scanner has already been under complete commercial use in European Union and Canada. According to the company, no adverse effects have been reported yet.

According to reports, more than 2.5 million people annually suffer from pressure ulcers in the United States. The authorization of the SEM Scanner became significant because current decisions of clinicians are subjective.

Even after completing the skin and tissue assessment, clinicians sometimes fail to detect the areas of pressure ulcers’ risk. By the time the sore becomes visible at the surface of the skin, the tissues are already damaged.

As claimed by the company, the analyses of the SEM Scanner give objective clinical information. This leads clinicians to start working on risks of developing pressure ulcers before the damage actually occurs. The data by SEM Scanner enables to carry specific interventions to reverse the damaging effects.

Dr. Ruth Bryant, a SEM Scanner study investigator stated that SEM Scanner will enable to resolve the bedsore issues easily. It will lead to fewer pressure sores, decreased costs, and increased quality of patient care.

Dr. Barbara Bates Jensen, a professor at the UCLA School of Nursing and a co-inventor of the SEM Scanner also expressed that SEM Scanner gives the unbiased and scientific data that brings confidence to clinicians to take preventive actions.

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