The Korean Food and Drug Administration (KFDA) has granted pre-market clearance for ETView's VivaSight-SL airway management system.
VivaSight-SL is a proprietary, single-use, disposable system, comprising of a single lumen airway ventilation tube with an integrated, continuous video airway imaging system which permits airway control and lung isolation during certain surgical procedures.
As part of the approval, the company has also signed a distribution agreement with ChinooMTech company.
Under the agreement, ChinooMTech will commercialize the VivaSight-SL airway management system in Korea for a period of 2 years.
ETView Medical CEO William Edelman said with KFDA clearance, the company believes that VivaSight-SL will provide airway management solutions for sophisticated thoracic surgical procedures requiring lung isolation.