GI Dynamics Inc. continues to face stumbling blocks in its bid to obtain FDA approval for its endoscopically-delivered device therapy for the treatment of Type 2 diabetes and obesity. The Lexington, Mass-.based company said on Tuesday, that its Endobarrier device failed to meet safety and efficacy endpoints in the ENDO pivotal trial, but noted it would still continue to move forward with plans to gain FDA approval.
Avinger Inc. might have set guidance significantly lower than consensus, but any potential backlash from investors and analysts was slightly muted by the company receiving FDA clearance for an enhanced version of its Pantheris lumivascular atherectomy system.