ETView files FDA 510(k) application for Vivasight system

ETView Medical has registered its Vivasight DL airway management system pre-marketing application (PMA) (510(k) with the US Food and Drug Administration (FDA).

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.

The company said it will await for FDA’s feedback during the next quarter and anticipates entering the US market with the Vivasight DL Airway Management System during 2012.

ETView Medical CEO Bill Edelman said Vivasight DL will be available to the US thoracic surgical community following FDA concurrence with their 510(k) pre-market application.