Breathe Technologies’ NIOV System Gets Fifth 510(k) Clearance

Breathe Technologies’ Non-Invasive Open Ventilation system has been granted 510(k) clearance for a fifth indication. The new indication, for use with compressed air supply for non-oxygen dependent patients, will expand the device’s patient pool to those with decreased respiratory ability caused by neuromuscular, rather than just respiratory, diseases, the devicemaker said.

NIOV — which improves rehabilitation efforts in patients who can spontaneously breathe a minimum tidal volume of 3.5 mL/kg of expected body weight — was previously cleared for home and institutional use with compressed oxygen with both invasive and noninvasive circuits. In seven studies, the device reduced dyspnea, increased oxygenation, enhanced exercise tolerance and unloaded respiratory muscle activity, the Irvine, Calif., devicemaker said Thursday.

The system weighs one pound and includes six components: an oxygen regulator, supply hose, purge tube, belt clip, battery charger and ventilator with touchscreen that shows patients their respiration rates and oxygen flow and allows them to make adjustments. — Lena Freund

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