Our Symphony CGM System is currently in development with an advanced prototype of the Symphony CGM biosensor. Echo has successfully completed numerous clinical trials with Symphony and is currently conducting a multi-center clinical trial to support a CE Mark Technical File for marketing approval in Europe.
A 510(k) equivalency study was completed to determine the efficacy of Prelude in enhancing the onset of the effectiveness of 4% lidocaine cream.
A 510(k) premarket notification has been submitted to the US Food and Drug Administration (FDA) for the Prelude SkinPrep System for the delivery of 4% lidocaine cream.
Durhalieve is Echo's topical AzoneTS reformulation of triamcinolone acetonide for treatment of corticosteroid-responsive dermatoses. Durhalieve has completed Phase III clinical trials and, in order to obtain FDA approval, Echo mus satisfy certain clinical and manufacturing development requirements outlined by the FDA when they last reviewed the Durhalieve New Drug Application.