FDA grants 510(k) clearance for Breathe Technologies’ Life2000 ventilator

16 June 2015 (Last Updated June 16th, 2015 18:30)

Breathe Technologies has received 510(k) clearance from the US Food and Drug Administration (FDA) for its critical care Life2000 ventilation system.

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Breathe Technologies has received 510(k) clearance from the US Food and Drug Administration (FDA) for its critical care Life2000 ventilation system.

The Life2000 ventilation system is designed to provide continuous or intermittent support for the care of individuals who require mechanical ventilation.

Breathe Technologies president Larry Mastrovich said: "This clearance underscores our commitment to providing healthcare providers and patients with another therapeutic option for critical care ventilation."

"The Life2000 ventilation system is designed to provide continuous or intermittent support for the care of individuals who require mechanical ventilation."

Suitable for use in the home and institutional settings, the ventilation system is indicated for adult patients who require positive pressure ventilation delivered invasively, through an ET tube or non-invasively, through a mask.

The ventilator was designed for administration by qualified, trained personnel under the direction of a physician.

Breathe Technologies anticipates that the Life2000 ventilation system will be commercially available in the US later in 2015.

Headquartered in California, US, 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.

NIOV is approved by the FDA for use by individuals who experience shortness of breath or have difficulty breathing due to chronic obstructive pulmonary disease stages III-IV, interstitial lung disease, neuromuscular conditions, as well as pre / post lung transplant.


Image: Respiratory therapist examining a mechanically ventilated patient on an Intensive Care Unit. Photo: courtesy of Rcp.basheer.