– Breathe Technologies, Inc., a developer and manufacturer of
medical technologies for patients with respiratory insufficiency and neuromuscular diseases,has
announced that the U.S. 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.
Source credit: Breathe Technologies, Inc.
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Breathe Technologies, Inc., invasively, neuromuscular, medical technologies
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).