The CE mark approval enables PneumRx to move forward with commercialization in Europe and other select markets. PneumRx intends to launch its RePneu LVRC System in Europe in the last quarter of 2010. PneumRx plans to continue its ongoing partnership with physicians through training and by offering novel products for the diagnosis and treatment ... CI-1 ELEVAIR™ Endobronchial Coil System U.S. Food & Drug Administration Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Jun 15, 2018 · An FDA advisory committee panel voted against recommending premarket approval for PneumRx’s Elevair lung implant for patients with severe emphysema. ... The device previously received a CE Mark ... Here's the most recent news related to BTG. Interventional medicine player BTG and imaging company Mirada Medical earned a CE mark for their dosimetry software for the planning of selective ... M2 PHARMA-May 15, 2012-CE Mark receieved by MAQUET Cardiovascular for MEGA intra-aortic ballon caatheter sizes(C)2012 M2 COMMUNICATIONS Provider of cardiovascular technologies MAQUET Cardiovascular LLC on Tuesday announced that it has received the CE mark for its new MEGA 7.5Fr. 30cc and 40cc intra-aortic balloon catheters.