ETView Medical has announced it has received FDA 510(k) clearance for its VivaSight-DL airway management system, according to a news release.
The VivaSight-DL family of products is designed to provide continuous airway visualization during thoracic surgical procedures requiring lung isolation.
"We are excited to have reached this milestone," said Bill Edelman, CEO of ETView, in the release. "We anticipate significant clinical interest for this innovative technology in the markets where VivaSight-DL is cleared for commercial distribution. With both VivaSight-SL and VivaSight-DL available in the United States, ETView can now offer a complete airway management solution for 100 percent of lung-isolation surgeries. We look forward to additional regulatory clearances worldwide which will expand the market for our VivaSight portfolio."
ETView expects to enter the U.S. market with the VivaSight-DL system immediately. Additional pre-market regulatory clearances in Europe and Asia are anticipated during 2012.
ETView Medical is headquartered in Tel Aviv, Israel.
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