The Chinese State Food and Drug Administration (SFDA) ihas cleared the pre-marketing notification application for ETView Medical’s VivaSight-SL airway management device.
The device, which is included in the company’s patented VivaSight airway management portfolio, is a single-use disposable single lumen ventilation tube with an integrated continuous high resolution video imaging system, for use in lung isolation procedures such as thoracic, cardiac, vascular or esophageal surgeries.
The company, which anticipates additional pre-market regulatory clearances during 2013, said the device will be distributed throughout China by Sinopharm.
ETView CEO Bill Edelman said the company anticipates significant clinical interest where the product is cleared for commercial distribution.
"With our line of VivaSight products available in the US, South America, Europe and now China, ETView offers a complete airway management solution for 100% of lung-isolation surgeries," Edelman said.
"We look forward to additional regulatory clearances world-wide which will expand the market for our VivaSight portfolio."
ETView’s VivaSight airway management portfolio also includes VivaSight-DL, a double lumen ventilation tube.
Earlier in 2012, the company received European pre-market clearance for the Viva-EB product family, which provides endobronchial blockade of the right or left lung for thoracic surgical procedures requiring lung isolation.