Inova Labs (Austin, TX), a manufacturer of products to treat chronic obstructive pulmonary disease (COPD), has received CE Mark approval for its LifeChoice portable oxygen concentrator, enabling the firm to market the device in Europe. The company plans to begin marketing the device in the EU in early 2012.
The LifeChoice portable oxygen generator received 510(k) clearance from the FDA in 2007. The device has also been authorized by FAA to be used during air travel.
From the announcement:
“This is a major milestone for our Company and for COPD patients who are on Long Term Oxygen Therapy,” said John Rush, CEO of Inova Labs. “The LifeChoice® technology allows patients to continue to live their daily lives with minimal disruption despite the advanced stage of their COPD disease.”
Inova Labs describes the device as the lightest and smallest oxygen concentrator on the market cleared by FDA for continuous use by patients. The LifeChoice system provides “Auto Mode” technology that allows patients to automatically receive the prescribed oxygen dose during periods of activity and sleep. The unit’s battery is designed to last longer than five hours.
Press release: Inova Labs Receives CE Mark Approval for the LifeChoice® Portable Oxygen Concentrator System