China awarded ETView Medical (TLV:TLV) pre-marketing approval for its Viviasight SL device, a single-use surgical device for pulmonary procedures.
The Viviasight SL device uses a small camera and ventilation tube to help surgeons with lung isolation during thoracic, cardiac, vascular or esophageal procedures, according to a press release.
The Tel-Aviv-based company said it expects additional regulatory clearances worldwide throughout 2013.
Viviasight SL will be distributed by the National Pharmaceutical Group Corporation, the largest state-owned healthcare group and drug maker in China. The device has already been cleared by the FDA in the U.S. and won CE Mark approval in the European Union.
"We are excited to have reached this milestone," CEO Bill Edelman said in prepared remarks."We anticipate significant clinical interest for this innovative technology in the markets where VivaSight-SL is cleared for commercial distribution."
Last year, ETView Medical signed a distribution deal in Mexico for the Viviasight device. Last summer, ETView Medical won FDA clearance and CE Mark clearance for Viva EB, a catheter-based thoracic surgical imaging device.