Breathe Technologies’ Life2000 ventilation system has secured FDA 510(k) clearance, the Irvine, Calif., devicemaker said Monday.
The system is indicated for continuous or intermittent ventilatory support in adult patients who require invasive or noninvasive positive pressure ventilation. The system can be used in home and hospital settings, the company says.
The devicemaker plans to launch the product in the U.S. late this year.
Breathe Technologies creates products for patients with respiratory insufficiencies and neuromuscular diseases. — Jason Scott