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ImpediMed Secures FDA Clearance for Sarcopenia Risk Assessment

The U.S. Food and Drug Administration has granted 510(k) clearance to ImpediMed’s SOZO Digital Health Platform for the assessment of sarcopenia risk. This expanded indication allows clinicians to identify muscle loss during routine scans, offering a non-invasive alternative to traditional imaging like CT scans or DXA for patients undergoing cancer treatment.

ImpediMed Secures FDA Clearance for Sarcopenia Risk Assessment
Photo: Bio & News

Sarcopenia, characterized by the progressive loss of skeletal muscle mass and function, frequently remains undetected in oncology settings. Approximately one in three breast cancer patients experience muscle depletion during chemotherapy, a condition often masked by stable body weight or standard BMI measurements. By utilizing bioimpedance spectroscopy (BIS), the SOZO system measures impedance across 256 frequencies to provide a detailed view of body composition. This technology enables practitioners to track muscle health over time, facilitating earlier intervention before structural damage becomes irreversible.

Dr. Jay K. Harness, founder of CancerFitness.org, noted that the inability to monitor muscle mass in real-time has historically hindered treatment outcomes, as patients with reduced muscle mass often struggle to tolerate chemotherapy and face slower recovery. The new capability will integrate into existing clinical workflows, allowing oncology teams to extract sarcopenia risk data from the same scans currently used for lymphedema monitoring. ImpediMed plans to roll out this feature with the v6.3 software release scheduled for fall 2026. Beyond oncology, the company anticipates the tool will assist in managing muscle health for patients with heart failure, metabolic disorders, and obesity.

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