Echo continues to enroll subjects in its multi-center European regulatory trial of the Symphony CGM System in surgical patients in hospital critical care units. Slower than expected initial enrollment in the trial and other issues inherent in clinical studies conducted in hospital critical care units caused delays in the anticipated completion of the trial in third quarter. Echo now expects to announce the top-line clinical results during the fourth quarter. Following successful completion of the EU clinical trial and preparation of the Conformite Europeenne Technical File, the company plans to submit the file for European approval late in the fourth quarter. Subsequent to the completion of the EU approval process, a decision will be made on when to initiate a limited launch of the Symphony CGM System. The decision will be based on a number of factors including the timing and implementation of product enhancements that have been identified in the ongoing clinical trial.
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