Monday, August 27, 2012
Pulmonx to start clinical trials for emphysema device
A Redwood City company has received the U.S. Food and Drug Administration’s OK to start clinical trials for a device to treat emphysema. Pulmonx’s “Zephyr Endobronchial Valve” device is already commercially available in Europe. The company said in a press release Monday that it received an “investigational device exemption” from the FDA that will allow it to start a multi-center trial in the U.S. The results from the new trial will be used for a premarket approval application with the FDA.