Sozo Cleared for Assessing Protein Calorie Malnutrition

FDA has cleared an ImpediMed 510(k) for Sozo, intended for use as an aid in assessing protein calorie malnutrition. Previously, the device was cleared as an aid in the early detection of secondary lymphedema, and determining fluid status for patients living with heart failure. The expanded clearance permits Sozo to assess patients at risk of protein calorie malnutrition and to track clinically relevant body composition parameters over time in both healthy and unhealthy patient populations, according to the company. It is also intended to aid clinicians who are using subjective global assessment tools to assess at-risk patients, it says. The device measures “256 unique data points over a wide spectrum of frequencies from 3 kHz to 1000 kHz to provide a detailed fluid and tissue analysis, including the L-Dex score, to establish patient baselines and monitor trends over time,” it adds.