SOZO® Digital Health Platform Receives FDA Clearance for Sarcopenia Risk Assessment

Expanded indication enables clinicians to detect sarcopenia risk from the same rapid SOZO scan, supporting earlier intervention in cancer care.

CARLSBAD, Calif., Aug. 18, 2026 /PRNewswire/ — ImpediMed, a leader in the development and commercialization of medical technologies to clinically monitor and manage fluid and body composition, today announced it has received U.S. Food and Drug Administration 510(k) clearance for sarcopenia risk assessment on its SOZO® Digital Health Platform. Under the new indication, the SOZO system may be used to assess patients at risk of sarcopenia, a disease of low muscle mass or muscle loss. The clearance makes SOZO the only FDA-cleared bioimpedance spectroscopy (BIS) solution for the clinical assessment of sarcopenia risk.

Sarcopenia, the accelerated loss of skeletal muscle mass and function, develops in roughly one in three breast cancer patients during chemotherapy and is associated with worse outcomes. It frequently goes undetected, in part because reference-standard tools, dual-energy X-ray absorptiometry (DXA) and computed tomography (CT), aren’t built for the fast, repeatable monitoring that early detection requires.

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