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Medical Devices / Submissions and Approvals

Bedsore Scanner Receives Marketing Authorization From FDA

Jan. 4, 2019
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The FDA granted Bruin Biometrics marketing clearance for its SEM Scanner, a wireless device that complements the standard of care for assessing patients at higher risk of pressure ulcers.

The scanner can identify specific areas of the patient’s body that are at increased risk of pressure damage.

Patient risk assessments can be performed with the device before visible damage appears on the surface of the skin.

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