ImpediMed this week said it received expanded FDA 510(k) clearance for its Sozo bioimpedance spectroscopy device.
The expanded clearance allows the Carlsbad, Calif.-based company to market the Sozo device for assessing patients that are at risk of Protein Calorie Malnutrition (PCM) and for tracking clinically relevant body composition parameters in all patients.
“Many chronic diseases, including cancer, COPD, CHF and liver disease are associated with PCM,” chief medical officer at Vitality HealthPlan Scott Howell said in a news release. “The consequences can be significant, including increased mortality, prolonged hospital stays and poor wound healing. A proactive, screening-based approach for nutritional support, employing Sozo could lead to significantly improved clinical outcomes for patients.”
Sozo currently measures 256 unique data points over a wide spectrum of frequencies that range from 3kHz to 1000 kHz, according to the company. It provides detailed fluid and tissue analysis to establish patient baselines and monitor trends over time. The device can provide early detection of secondary lymphedema, provide fluid status for patients living with heart failure and can be used to monitor and maintain overall health.
Original Article: (https://www.massdevice.com/impedimed-lands-expanded-510k-clearance-for-sozo/)