The US Food and Drug Administration (FDA) has granted 510(k) approval to ETView Medical's VivaSight-DL airway management system.
Vivasight DL is a proprietary, single-use disposable device comprising a dual lumen airway ventilation tube with an integrated continuous high resolution video airway imaging system.
The Vivasight DL is designed for permitting airway control and lung isolation during certain surgical procedures.
ETView CEO Bill Edelman said with availability of both VivaSight-SL and VivaSight-DL in the US, the company can now offer a complete airway management solution for lung-isolation surgeries.
"We look forward to additional regulatory clearances world-wide which will expand the market for our VivaSight portfolio," Edelman added.