Jul 2 2012
ETView (TASE: ETVW) today announced that the company has received European pre-market clearance for the Viva™-EB product family following review of a Technical File submission by Medical Device Certification GmbH ("MDC"). The European pre-market clearance completes the Conformité Européenne, or "European Conformity" ("CE") registration process. Following award of CE registration, the Company expects to immediately begin distribution of the Viva™-EB line of innovative airway devices in countries requiring CE registration of medical devices. In June, 2012, Viva™-EB received US FDA clearance of a 510(k) Pre-Marketing Notification. Additional pre‐market regulatory filings in Europe and Asia are anticipated during 2012.
“Viva™-EB will be immediately available to the European thoracic surgical community following MDC concurrence with our CE registration application. We anticipate significant clinical interest for VivaSight™‐DL when it is cleared for commercial distribution.”