FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Gecko Biomedical Receives CE Mark Approval for SETALUM Sealant

Sept. 14, 2017

Gecko Biomedical received CE Mark approval for its SETALUM Sealant allowing the company to market the technology in Europe.

The bioresorbable sealant can be used as an add-on to sutures during vascular surgery. The polymer is applied to tissue in-situ and activated using a proprietary light activation pen.

The CE Mark is the first regulatory validation of Gecko Biomedical’s polymer platform.

View today's stories