ETView Medical has obtained CE mark approval for its VivaSight-DL airway management system.
Single-use, disposable VivaSight-DL system comprises of a dual lumen airway ventilation tube with an integrated, continuous high-resolution video airway imaging system permitting continuous airway visualization during thoracic surgical procedures requiring lung isolation.
ETView Medical CEO Bill Edelman said VivaSight-DL will be immediately available to the European thoracic surgical community following medical device certification concurrence with CE registration application.
"We anticipate significant clinical interest for VivaSight-DL when it is cleared for commercial distribution," Edelman added.
The US Food and Drug Administration has cleared VivaSight-DL’s 510(k) pre-marketing notification in May 2012 and additional pre-market regulatory filings in Europe and Asia are anticipated during 2012.