The FDA granted 510(k) clearance for ImpediMed’s noninvasive bioimpedance spectroscopy system for assessing patients at risk of protein calorie malnutrition.
Previously cleared for assessing a patient’s fluid levels and tissue composition, the device is intended to help in the assessment of secondary lymphedema, a condition that causes swelling. It occurs from blocks or losses in the lymphatic system.
The agency has cleared the device for assessing patients that are at risk of decreased protein with or without fat loss, which can weaken their functional capacity. The product is also cleared for tracking clinically significant body composition parameters over time.