FDA Clears Digital Health Device to Assess Protein Calorie Malnutrition

The US Food and Drug Administration (FDA) has granted 510(k) clearance for ImpediMed Limited’s noninvasive bioimpedance spectroscopy device for use as an aid in the assessment of protein calorie malnutrition.

The digital health platform, SOZO, aids in the assessment of secondary lymphedema, and can deliver snapshots of fluid status and tissue composition in less than 30 seconds, according to ImpediMed Limited. SOZO measures more than 250 unique data points across a spectrum of frequencies—from 3kHz to 1000 kHz—to provide analysis, including the L-Dex score, to establish patient baselines and monitor trends over time.

SOZO provides values for fluid accumulation and muscle and fat mass to provide data critical to nutritional evaluations. The readings could allow clinicians to provide individualized, proactive care to improve patient outcomes.

The platform includes hand and foot plates attached to a pedestal and controlled with an Android tablet pre-installed with the SOZOapp. Patient records, measurement data, and other calculated trends are stored in the MySOZO cloud.

Chronic diseases including cancer, chronic obstructive pulmonary disease (COPD), congestive heart failure, and liver disease are associated with protein calorie malnutrition, which could lead to an increase in mortality and hospital stays, Scott Howell, DO, MPH & TM, chief medical officer at Vitality HealthPlan, said.

“A proactive, screening-based approach for nutritional support, employing SOZO could lead to significantly improved outcomes for patients,” Howell said in a statement.

With the clearance, ImpediMed will market SOZO to assess patients at risk of protein calorie malnutrition and track body composition parameters in healthy and unhealthy populations.