摘要：医疗科技公司 ImpediMed 于 2026 年 8 月 18 日宣布，其 SOZO 数字健康平台正式获得美国食品药品监督管理局（FDA）的 510(k) 许可，用于肌肉减少症（肌少症）的风险筛查与评估。该系统成为首个且唯一获 FDA 批准用于评估肌少症风险的生物阻抗谱（BIS）解决方案。
Carlsbad, CA (August 18, 2026)— 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.
Sarcopenia also impacts patients with chronic conditions like heart failure and patients with metabolic disorders such as type 2 diabetes or obesity where routine screening can help support better disease management.
Now clinicians can assess sarcopenia risk in their clinics using SOZO’s BodyComp™ muscle-mass indices, drawn from the same SOZO scan many oncology teams already use to monitor for lymphedema and track body composition.
“In cancer care, we treat the tumor, but we too often lose sight of the patient’s muscle mass, which can determine how well someone tolerates treatment and recovers. A patient who loses muscle may tolerate chemotherapy less well, faces more potential complications, and can recover more slowly. Until now, we haven’t had a practical way to see that happening in the clinic. Flagging the risk early, from a routine scan, means we can act while it’s reversible,” said Jay K. Harness, MD, FACS, FASBrS, Founder of CancerFitness.org and a Past-President of the American Society of Breast Surgeons (ASBrS).
Muscle loss can hide behind a stable weight or a normal BMI. SOZO’s muscle-mass indices give clinicians the clarity to separate muscle from fat. Because those indices track muscle health over time, clinicians can recognize meaningful change and intervene sooner rather than reacting to symptoms after they appear.
“Sarcopenia is one of the most consequential and most overlooked risks in cancer care. Patients lose muscle during treatment, and too often no one catches it until the damage is done,” said Erik Anderson, CEO & Managing Director, ImpediMed. “Expanding SOZO into sarcopenia risk assessment means clinicians now have a practical way to see what’s happening inside the body, from a simple scan that fits right into their workflow. Getting there sooner means patients have a better chance of staying strong enough to finish treatment, recover well, and reduce their risk of cancer recurrence. This clearance is a meaningful step forward for SOZO’s capabilities, and we look forward to making it available to clinicians.”
The sarcopenia capability will be introduced with ImpediMed’s upcoming SOZO software release (v6.3), expected in fall 2026.
What is sarcopenia, and why does it matter for people with cancer?
Sarcopenia is a progressive skeletal muscle disorder, low muscle mass combined with reduced strength or function. In oncology it can precede a diagnosis, result from the cancer itself, or be driven by treatment through inflammation, metabolic stress, reduced activity, and poor nutrition. Low skeletal muscle mass is associated with worse survival in patients with breast cancer, and sarcopenic patients tolerate chemotherapy less well and face more postoperative complications. Critically, sarcopenia is modifiable. Resistance exercise and optimized nutrition can rebuild muscle, and because sarcopenia grows harder to reverse over time, finding it early matters.
How does SOZO assess sarcopenia risk?
SOZO uses bioimpedance spectroscopy (BIS), measuring impedance across 256 frequencies to differentiate intracellular and extracellular fluid and estimate lean and skeletal muscle mass. Where single-frequency bioelectrical impedance analysis (BIA) offers one snapshot, that full spectrum resolves body composition with the precision a clinical decision requires. A quick, non-invasive scan produces immediate results, making it practical for the serial monitoring that tracking muscle over time demands. DXA and CT are accurate but aren’t designed for frequent, repeated use; DXA requires a dedicated appointment and CT is typically reserved for staging. In patients with early breast cancer, sarcopenia detected by BIS was associated with more than double the odds of chemotherapy toxicity, and researchers concluded BIS is a high-value, radiation-free alternative to CT for sarcopenia assessment.
医疗科技公司ImpediMed于2026年8月18日宣布，其SOZO数字健康平台已获得美国食品药品监督管理局（FDA）510(k)许可，可用于肌肉减少症风险评估。这一新适应症允许SOZO系统利用其BodyComp™肌肉质量指数评估有肌肉减少症风险的患者。肌肉减少症的特征是肌肉质量低或肌肉流失，在化疗期间的乳腺癌患者中约有三分之一受影响，并与较差的预后相关。然而，由于当前参考标准工具（如DXA和CT扫描）存在局限性，不适合进行快速、可重复的监测，该病症往往未被发现。此次许可使SOZO成为唯一获FDA批准用于临床肌肉减少症风险评估的生物阻抗光谱解决方案，从而实现早期干预。该技术还惠及患有慢性心力衰竭以及2型糖尿病和肥胖等代谢性疾病患者，常规筛查有助于改善疾病管理。