Echo Therapeutics (NSDQ:ECTE) said it filed for CE mark approval in the European Union for its Symphony continuous glucose monitoring system.
Symphony is a non-invasive, wireless system designed to provide accurate, real-time blood glucose data for patients in hospital critical care settings.
The Philadelphia-based medical device company has made a lot of headway with the Symphony system in the past year, running a clinical trial for the CE Mark approval that met its primary safety and effectiveness endpoints. Echo Therapeutics also pulled down a $3.2 million in a funding round and inked 10-year deal with Hong Kong-based Medical Technologies Innovation Asia for the exclusive rights to market the technology in China.
“This filing marks the successful culmination of efforts to execute on the multitude of directives required for an anticipated CE Marking and would not have been possible without the dedication of our team. With the completion of this important regulatory step, we can now focus on the implementation of the product enhancements essential to the initial European launch, as well as to the planned U.S. pivotal trial. We look forward to providing further updates on our progress as we prepare for a limited launch of Symphony in Europe,” chairman & interim CEO Robert Doman said in prepared remarks.
The last year has also seen a raft of changes at Echo. The company cut ⅓ of its workers in Oct. after parting ways with former CEO & co-founder Patrick Mooney, who remains on the board.
