FDA Greenlights VivaSight Disposable Imaging Product for Sale in U.S.
Tel Aviv, Israel-based ETView Medical announced this week that it has secured FDA approval to market its VivaSight airway imaging surgical system and plans to bring the technology immediately to U.S. customers.
VivaSight is a single-use, disposable ventilation device "with an integrated continuous high resolution video airway imaging system permitting airway control and lung isolation during certain surgical procedures," according to a company press release. ETView claims the technology eliminates the need for fiberoptic bronchoscope imaging during thoracic, cardiac, vascular, or esophageal surgeries.
"We look forward to additional regulatory clearances world-wide which will expand the market for our VivaSight(TM) portfolio," said ETView CEO Bill Edelman in a statement accompanying the release.