Breathe Technologies has received the US Food and Drug Administration (FDA) 510(k) clearance for its critical care Life2000 Ventilation System.
The ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It is indicated for adult patients who require positive pressure ventilation delivered invasively (via ET tube) or non-invasively (via mask).
The ventilator is suitable for use in home and institutional settings and is intended to be administered by qualified, trained personnel under the direction of a physician.
“This clearance underscores our commitment to providing healthcare providers and patients with another therapeutic option for critical care ventilation,” said Larry Mastrovich, President and CEO, Breathe Technologies.
The company anticipates that the Breathe Technologies Life2000 Ventilation System will be commercially available in the United States in late 2015.