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FDA clears sale of patient-controlled ventilator
The US Food and Drug Administration (FDA) has given 510(K) clearance to Maquet Critical Care of Solna, Sweden, to market its Servo-i ventilator with the NAVA (Neurally Adjusted Ventilatory Assist) option. Sales of the system, which aims to treat and monitor neonatal, infant and adult patients, should begin this year. In addition, current Servo-i users can upgrade their system with NAVA.