ImpediMed (ASX:IPD) has secured US Food and Drug Administration (FDA) 510(k) clearance for its SOZO Digital Health Platform to assess patients at risk of sarcopenia, expanding the clinical applications of its bioimpedance spectroscopy technology.
The clearance makes SOZO the only FDA-cleared bioimpedance spectroscopy (BIS) solution for the clinical assessment of sarcopenia risk, according to the company.
Sarcopenia involves the progressive loss of skeletal muscle mass and function and can affect patients undergoing cancer treatment as well as people with chronic conditions including heart failure, type 2 diabetes and obesity.
ImpediMed (ASX:IPD) said clinicians will be able to assess sarcopenia risk using SOZO’s BodyComp muscle-mass indices as part of the same scan already used by some oncology teams to monitor lymphedema and body composition.
Expands SOZO clinical applications
The new indication broadens the potential role of SOZO in oncology by allowing clinicians to monitor changes in muscle mass over time and identify patients who may require earlier intervention.
ImpediMed said muscle loss can occur without obvious changes in weight or body mass index, making direct assessment of muscle and fat composition important for identifying deterioration.
CEO and managing director Erik Anderson said the clearance gave clinicians a practical way to monitor muscle changes through a scan that could be incorporated into existing clinical workflows.
“This clearance is a meaningful step forward for SOZO's capabilities, and we look forward to making it available to clinicians,” Anderson said.
How SOZO assesses sarcopenia risk
SOZO uses BIS technology to measure impedance across 256 frequencies, enabling it to differentiate intracellular and extracellular fluid and estimate lean and skeletal muscle mass.
The non-invasive scan produces immediate results and is designed to support repeated monitoring over time.
ImpediMed said this provides an alternative approach to dual-energy X-ray absorptiometry (DXA) and computed tomography (CT), which can accurately assess body composition but are not generally designed for frequent monitoring.
The company cited research in patients with early breast cancer showing sarcopenia detected using bioimpedance was associated with more than double the odds of chemotherapy toxicity.
Next steps
ImpediMed plans to introduce the sarcopenia assessment capability as part of its upcoming SOZO software release, version 6.3, which is expected in the second quarter of FY27.
About ImpediMed
ImpediMed is a Sydney-headquartered medical technology company with operations in the US and Europe.
Its SOZO Digital Health Platform uses BIS technology to provide real-time information on fluid status and tissue composition. The platform is FDA-cleared for applications including secondary lymphedema detection, fluid-status assessment in heart failure patients and sarcopenia risk assessment.
SOZO is also used in cancer survivorship programs and medical weight-management settings, including for patients receiving GLP-1 therapies.