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TEL AVIV, Israel--(BUSINESS WIRE)--ETView today announced that the company has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA). The Company expects feedback from the FDA during the next quarter and anticipates entering the US market with the VIVASIGHT™ DL Airway Management System during 2012. Additional pre-market regulatory filings in Europe and Asia are anticipated during 2012.

About the VIVASIGHT™ DL Airway Management System

VIVASIGHT™ DL1 is a proprietary, single-use disposable medical device, consisting of a dual lumen airway ventilation tube with an integrated continuous high resolution video airway imaging system permitting airway control and lung isolation during certain surgical procedures. Lung isolation is employed to provide one-lung ventilation in patients undergoing thoracic, cardiac, vascular or esophageal surgeries.2 During lung isolation, temporary visualization of the patient airway is achieved with a fiberoptic bronchoscope while the patient is ventilated and the target lung isolated. Intra-operative surgical maneuvers often requires repeated imaging and partial blocking of the airway to maintain lung isolation3. It is estimated that over 1.9 million lung isolation procedures are conducted world-wide annually4, accounting for over $250MM in single-use medical disposables5. ETView has pioneered development of the VIVASIGHT™ platform (previously known as TVT™), combining an airway ventilation tube with integrated continuous high resolution airway imaging for patient airway control and lung isolation capability (eliminating the need for fiberoptic bronchoscope6 imaging during these procedures).

"We are excited to have reached this milestone," stated Bill Edelman, CEO. He continued, "VIVASIGHT™ DL will be available to the US thoracic surgical community following FDA concurrence with our 510(k) pre-market application. We anticipate significant clinical interest for this innovative technology in the markets where VIVASIGHT™ DL will be cleared for commercial distribution."

About ETView, Medical, Ltd.

ETView Medical Ltd. has successfully combined airway management with continuous direct airway visualization for medical professionals. ETView's patented VIVASIGHT™ SL, a single-use disposable medical device, consisting of a single lumen ventilation tube with an integrated continuous high resolution video imaging system is currently sold in Europe, Israel, and the US to overcome current limitations and associated adverse surgical events during lung isolation surgeries7. Visit www.etview.com for additional information.

1 Patent Pending

2 Principles and Practices of Anesthesia for Thoracic Surgery P. Singer (ed.) 2011

3 Anesthesia & Analgesia 2009;108:1097–101

4 National Health Statistics Reports Number 29, October 26, 2010

5 Company estimates on file

6 Minerva Anestesiol 2009;75(Suppl 1):1-4.

7 Anesthesiology 2006;105:471–7.

Posted by Sean Fenske, Editor-in-Chief, MDT

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