The US FDA has granted 510(k) clearance for the critical care Life2000 Ventilation System by Breathe Technologies, which is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation, according to a company announcement.
The Life2000 Ventilation System is indicated for adult patients who require positive pressure ventilation delivered invasively (via ET tube) or noninvasively (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, according to Breathe Technologies.
“We are pleased to announce the FDA clearance of the Breathe Technologies Life2000 Ventilation System,” said Larry Mastrovich, president and CEO of Breathe Technologies. “This clearance underscores our commitment to providing healthcare providers and patients with another therapeutic option for critical care ventilation.”
The company anticipates that the device will be commercially available in the United States in late 2015.