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  • SOZO® Receives FDA Clearance for Sarcopenia Risk Assessment

SOZO® Receives FDA Clearance for Sarcopenia Risk Assessment

ImpediMed has announced that its SOZO® Digital Health Platform has received U.S. Food and Drug Administration (FDA) 510(k) clearance for sarcopenia risk assessment.

The new indication allows clinicians to assess patients who may be at risk of sarcopenia, a condition characterised by the loss of skeletal muscle mass and function. According to ImpediMed, SOZO is now the only FDA-cleared bioimpedance spectroscopy (BIS) solution for the clinical assessment of sarcopenia risk.

Sarcopenia is a common but often under-recognised condition that can impact treatment outcomes, recovery and quality of life. In oncology, muscle loss may occur during treatment and has been associated with poorer patient outcomes. Sarcopenia may also affect patients with chronic conditions such as heart failure, type 2 diabetes and obesity.

The new functionality enables healthcare professionals to assess sarcopenia risk using the same rapid, non-invasive SOZO scan already used by many clinicians for body composition and lymphoedema assessment. The platform's BodyComp™ muscle mass indices provide insights into muscle health and changes over time, helping clinicians identify potential concerns earlier and support timely intervention.

ImpediMed expects the new sarcopenia assessment capability to be available as part of the upcoming SOZO software release version 6.3.

Regional Health Care Group is proud to distribute the SOZO Digital Health Platform across Australia and New Zealand and welcomes this advancement in patient assessment technology.

About SOZO®

SOZO® is a digital health platform that uses bioimpedance spectroscopy (BIS) to assess fluid status and body composition through a quick, non-invasive scan. The platform is used across a range of clinical applications, including lymphoedema assessment and body composition monitoring.

Acknowledgement

This article is based on information provided by ImpediMed.  https://www.impedimed.com/sozo-digital-health-platform-receives-fda-clearance-for-sarcopenia-risk-assessment/  

SOZO® is a registered trademark of ImpediMed Limited and/or its affiliates.

Disclaimer

Information on this page is intended for healthcare professionals. Product indications and regulatory clearances may vary by country. Healthcare professionals should refer to applicable product documentation and local regulatory requirements before use.

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