GI Dynamics' EndoBarrier had its CE Mark suspended over nonconformances related to its quality management system.
Here's what you should know.
1. SGS United Kingdom Limited issued the suspension.
2. GI Dynamics CEO and President Scott Schorer said in a release the suspension is not related to EndoBarrier's safety and efficacy.
3. Mr. Schorer said the suspension does not require a recall.
"We are working swiftly to address issues within our quality management system that were detailed in a corrective action report from SGS," he said.
4. EndoBarrier hired a chief compliance officer with experience in the area to address the nonconformance issues SGS identified.
5. EndoBarrier has shipped a "sufficient" inventory to physicians to maintain supply levels through the suspension.