Breathe Technologies’ Ventilation System Receives FDA Clearance

Breathe Technologies, Inc., a developer and manufacturer of medical technologies for patients with respiratory insufficiency and neuromuscular diseases, announced this week that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Breathe Technologies Life2000 Ventilation System for patients who require mechanical ventilation.

The ventilation system is indicated for adult patients who require positive pressure ventilation delivered invasively via ET tube or non-invasively via a 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.

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