Breathe Technologies, Inc., a manufacturer of innovative medical devices for people with respiratory conditions today announced the Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its Sleep System (Continuous Positive Airway Pressure, or CPAP & Interface) in the US for treatment of Obstructive Sleep Apnea (OSA). The Breathe Sleep System utilizes miniaturized technologies coupled with user-centric design to provide a new therapeutic solution for patients with OSA.
"Reaching this milestone ahead of schedule is a testament to the expertise of our world-class team," said Larry Mastrovich , CEO of Breathe Technologies. "Our approach to respiratory care is centered on improving patients' quality of life. Based on extensive research with patients and clinicians, we have designed a clinically effective system with unique features."
Breathe's Sleep System is easy to set-up and provides effective CPAP therapy with a comfortable, discrete interface and tubing. Additional advanced features include a redesigned humidification system, an interactive patient touch-screen interface, and a smart pressure ramp function. Breathe Technologies product portfolio will be further enhanced with the addition of the Breathe Sleep System. Breathe Technologies' award-winning Non-Invasive OPEN Ventilation (NIOV™) System is a one pound, wearable hospital to home miniaturized ventilation device that facilitates early ambulation in hospital settings and enables patient independence in the home for better quality of life. NIOV™ is currently in use by clinicians and patients across the country, including public and private hospitals, VA healthcare facilities, pulmonary rehab centers, and with patients at home.
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