Breathe Technologies announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its critical care Breathe Technologies Life2000 Ventilation System, which is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
The Breathe Technologies Life2000 Ventilation System 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.
"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 Breathe Technologies Life2000 Ventilation System will be commercially available in the United States in late 2015.
Breathe Technologies is a developer and manufacturer of innovative medical technologies for patients with respiratory insufficiency and neuromuscular diseases.
The company also manufactures the Non-Invasive Open Ventilation (NIOV) System, the first lightweight and wearable ventilator on the market that reduces the work of breathing and supports improved patient mobility.