Medovex converted its FDA Investigational Device Exemption submission to a pre-submission.
Here are five points:
1. The submission regards its DenerveX System, which is designed to treat facet joint pain.
2. In a press release, Medovex's Senuior Vice President of Regulatory and Clinical Affairs Jill Schweiger said, "Converting the IDE submission to a pre-submission beneficially allows us to engage in a more interactive and collaborative review of the planned clinical investigation."
3. Medovex believes working with the FDA earlier in the process of the planned clinical evaluation will boost the study's efficacy and outcomes.
4. The DenerveX System has the CE Mark.
5. Medovex is collaborating with physicians in the U.K. and Germany to gather data on outcomes with the DenerveX System.