Provizio® SEM Scanner Achieves Expanded FDA Claims and CMS Procedure Code in the United States Further Advancing Pressure Injury Prevention for Patients and Providers

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Feb 02, 2024, 09:28 ET

LOS ANGELES, Feb. 2, 2024 /PRNewswire/ -- Bruin Biometrics LLC announces repeated formal recognition of the role of sub-epidermal moisture (SEM) in the identification of the increased risk of pressure injuries and of the Provizio SEM Scanner in the detection, and guided treatment of SEM for the prevention of broken skin pressure injuries.

Martin Burns, CEO of Bruin Biometrics, brings good news: "An increasing number of national and expert guidelines now recognize SEM assessment for pressure injury prevention due to the latest data on the ongoing challenges of pressure injuries and the importance of their prevention.

FDA, CMS, and device users now acknowledge the importance of that clinical foresight, which is acutely true for dark-skin-toned patients. Health economic modelling underscores its cost-effectiveness whilst freeing up healthcare practitioner time.

2023 was a year of groundbreaking clinical and health economic advancements with the Provizio SEM Scanner, the name of which was selected to suggest and highlight the 'foresight' this technology provides. The company and its collaborating practitioners and exclusive global distributor, Arjo, continue to modernise the landscape of pressure injury prevention in the US, with far-reaching positive effects for patients, globally.

In the United States:

The FDA has acknowledged that sub-epidermal moisture is the equivalent of persistent focal edema and localized edema: additionally, that sub-epidermal moisture is measured and monitored by the Provizio SEM Scanner, accepting an expanded labelling (K231830, September 2023).
The US Centers for Medicare and Medicaid (CMS) has approved the ICD-10 PCS procedure code, XX2KXP9, for the SEM scanning procedure, effective April 1, 2024, It recognizes the utility of the technology in measuring and monitoring SEM which, when treated, significantly aids in preventing pressure injuries and deep tissue injuries. This new code will play a significant role in promoting standardization of the procedure, especially for present on admission testing which is a major quality risk area for providers with consequential Medicare penalties for missed diagnoses.

These developments have broad implications for clinical practice. In the US, the 1% Medicare penalty for hospital-acquired pressure injuries again applies to clinical practice for the fiscal year from October 1, 2023, to September 30, 2024. Because of these Provizio SEM Scanner related milestones, healthcare providers and practitioners have coded procedures and a powerful tool for identifying and documenting pressure damage on admission, and Deep Tissue Injuries; and in particular for dark-skin toned patients.

For years, healthcare practitioners and policymakers have been frustrated from increased pressure injury incidence and associated resource burdens and treatment costs. From Bruin Biometrics' point of the view the current status quo around pressure injuries is simply inadequate resulting in too much avoidable patient suffering.

Burns concluded, "These approvals and authorizations are proverbial breaths of fresh air in a clinical area frustrated by detection, treatment and prevention methods not grounded in the contemporary etiology and pathophysiology. We have moved beyond the era of pressure injury risk-tools and visual and tactile skin assessments alone, and into an era where objective, microscopic measures guide practitioners' understanding of their patients' skin and tissue status."

* A pressure injury can also be known as a pressure ulcer, pressure sore, decubitus ulcer and bed sore.

For more information, please visit www.sem-scanner.com or contact Kate Hancock, EVP External Communications, at +447827315347 or [email protected].

Media contact details:   

Joanna Dodd, Alicia Barkle Rochester PR Group : [email protected] / [email protected]

1 K231830, September 2023: "The Provizio SEM Scanner S measures the electrical capacitance of tissue ("Biocapacitance"), below the electrode when placed on the patient's skin. Biocapacitance is a biophysical measure of changes in sub-epidermal moisture ("SEM") a physiological process associated with pressure-induced tissue damage, The Provizio SEM Scanner is designed to measure changes in SEM which is equally known in literature as persistent focal edema, or localized edema.

About Bruin Biometrics

Bruin Biometrics, LLC, is a pioneer in modernizing health care with biometric sensor technology for early detection and monitoring of chronic, preventable conditions in collaboration with clinicians.

Bruin Biometrics work on SEM Assessment Technology has been recognized with multiple global healthcare innovation awards and is implemented in healthcare facilities across a variety of care settings. Bruin Biometrics HQ is based in Los Angeles.

SOURCE Bruin Biometrics, LLC