FDA approves VivaSight (ETView Medical) for use in Lung Surgery

VivaSight, from ETView Medical, received clearance of a 510(k) Pre-Marketing Notification Application with the FDA. The company expects to enter the US market with the VivaSight-DL Airway Management System immediately. VivaSight-DL is a single-use disposable medical device, consisting of a dual lumen airway ventilation tube with an integrated continuous high resolution video airway imaging system permitting airway control and lung isolation during certain surgical procedures. Additional pre-market regulatory clearances in Europe and Asia are anticipated during 2012.