2020-02-26 08:18:03 CHFS CHF Solutions
02/26/20 02/2608:18 02/26/2008:18 | CHF Solutions receives 510(k) clearance for Aquadex SmartFlow systemCHF Solutions announced FDA 510(k) clearance in the U.S. of its next generation Aquadex SmartFlow console for use in adult and pediatric patients who weigh 20kg or more. The console is a simple, gentle, and smart solution for treatment of patients suffering from hypervolemia. In a retrospective, multi-center study, 32 pediatric patients weighing over 20 kgs and predominantly suffering from hypervolemia were treated with the Aquadex system and 97% survived to the end of therapy. |
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