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FDA grants 510(k) clearance for mechanical ventilation system

Breathe Technologies has received 510(k) clearance from the US Food and Drug Administration for a mechanical ventilation system, according to a company press release.

The Breathe Technologies Life2000 Ventilation System is intended to provide continuous or intermittent ventilator support for the care of adult patients who require positive pressure ventilation delivered invasively or non-invasively.

The ventilator is suitable for use in the home and in institutional settings, but it is meant to be administered by trained personnel, the release said.

The company expects the system to be available nationwide in late 2015, according to the release.