ImpediMed Gains FDA Clearance for SOZO Sarcopenia Assessment

CARLSBAD, Calif., August 18, 2026

FDA Clearance Expands SOZO Clinical Use

Sarcopenia is characterized by a progressive decline in skeletal muscle mass, strength and physical function and can be particularly important in patients undergoing cancer treatment. Muscle loss may develop because of cancer itself, inflammation, metabolic changes, reduced physical activity, inadequate nutrition or treatment-related effects. In breast cancer patients receiving chemotherapy, sarcopenia can be associated with poorer outcomes and increased treatment-related complications. ImpediMed states that the new FDA clearance makes SOZO the only FDA-cleared bioimpedance spectroscopy solution for clinical assessment of sarcopenia risk. The expanded indication allows clinicians to identify changes in muscle mass during routine care rather than relying exclusively on imaging methods that may be less practical for frequent monitoring. Early identification could help healthcare professionals consider nutritional support, resistance exercise or other interventions before progressive muscle loss becomes more difficult to reverse.

Bioimpedance Technology Enables Rapid Muscle Assessment

The SOZO Digital Health Platform uses bioimpedance spectroscopy (BIS) to assess fluid and tissue composition across a broad range of frequencies. The technology measures impedance at 256 frequencies, from 3 kHz to 1000 kHz, allowing the system to generate information about intracellular and extracellular fluid as well as lean and skeletal muscle mass. The rapid, non-invasive scan provides immediate results, making the platform suitable for repeated measurements and longitudinal monitoring. This capability is particularly relevant in oncology, where changes in muscle mass can occur during treatment even when a patient’s overall body weight or body mass index remains relatively stable. Traditional tools such as dual-energy X-ray absorptiometry (DXA) and computed tomography (CT) can provide detailed body-composition information, but they are not necessarily designed for rapid, repeatable monitoring during routine clinical visits. By providing muscle-mass measurements from a quick scan, SOZO is intended to give clinicians an additional tool for recognizing potential sarcopenia risk earlier.

New Capability Targets Earlier Intervention in Cancer Care

ImpediMed expects to introduce the sarcopenia assessment capability through its upcoming SOZO software release version 6.3, anticipated in fall 2026. The company believes the expanded functionality could help oncology teams incorporate muscle-health monitoring into existing workflows, particularly for patients receiving treatments that may contribute to muscle loss. Sarcopenia can also affect people with heart failure, type 2 diabetes, obesity and other chronic conditions, creating potential applications beyond oncology. The ability to track changes in muscle composition over time may support more personalized approaches to patient management and recovery. For cancer patients, maintaining adequate muscle mass can be important for treatment tolerance, recovery and overall physical resilience. The FDA clearance therefore represents a significant development for digital health and medical technology, expanding SOZO from established applications in fluid and tissue monitoring toward broader assessment of body composition and muscle health. As healthcare providers increasingly focus on early detection and personalized supportive care, non-invasive technologies capable of providing repeatable measurements could play an important role in monitoring patients throughout treatment.

Source: ImpediMed press relese