Mar 5 2012
ETView (TASE: ETVW) today announced that the company has successfully completed a Technical File submission for review by Medical Device Certification GmbH ("MDC"). The Technical File review initiates the Conformité Européenne, or "European Conformity" ("CE") registration process. Following award of CE clearance, The Company expects to begin distribution of the Viva™ EB Line of Endobronchial Blockers in countries requiring CE registration of medical devices. Feedback from MDC is anticipated during the next quarter. Additional pre-market regulatory filings in Europe and Asia are anticipated during 2012.
“Viva™ EB will be available to the European thoracic surgical community following MDC concurrence with our CE registration application. We anticipate significant clinical interest for the combined VivaSight SL/Viva™ EB products when Viva™ EB is cleared for commercial distribution.”