CE Mark suspended for GI Dynamics EndoBarrier

GI Dynamics (ASX:GID) said yesterday that the CE Mark approval for its EndoBarrier device was suspended for “nonconformances” in its quality management system under European Union regulations. GI Dynamics president & CEO Scott Schorer told MassDevice.com today during a telephone interview that the suspension is not a recall and does not involve the safety or efficacy of EndoBarrier, a plastic gut liner designed to treat obesity and diabetes. “It’s just an accumulation of lots of little things and some bigger things,” Schorer told us. “We’ve been trying to fix everything.” Schorer, a medical device veteran with stints as an executive or advisor at a raft of companies under his belt, has made a number of changes at GI Dynamics since taking over in March 2016. Brought on after a higher-than-expected rate of liver abscesses forced the halt of a clinical trial in 2015, it wasn’t long before he instituted a 30% cut to the workforce in an effort to cut the company’s cash burn as it pursues FDA approval for the EndoBarrier. The changes also included a reboot for the C-suite; Schorer tapped ex-Oxigene and HemaSure finance chief Jim Murphy to be CFO and recruited ex-Johnson & Johnson (NYSE:JNJ) and Covidien exec Brian Callahan as chief compliance officer. Today he told us that the new management team, knowing it had a long list of compliance issues to address right off the bat, initially focused on the highest-...
Source: Mass Device - Category: Medical Devices Authors: Tags: Diabetes Regulatory/Compliance Wall Street Beat Weight loss GI Dynamics Source Type: news