Weight loss: FDA asks for more info on EnteroMedics' Maestro implant

September 24, 2013 by Arezu Sarvestani

Weight-loss devices maker EnteroMedics says it's still on track with its premarket approval application, expecting a decision early next year despite the FDA's request for more information.

EnteroMedics is on track, forsees FDA decision early next year

Minnesota medical device maker EnteroMedics (NSDQ:ETRM) appeared unfazed by the FDA's response to the company's premarket approval application, anticipating no slowdown in the regulatory process for its landmark Maestro weight-loss implant.

"We are very encouraged by the responsiveness of the FDA and are confident in our ability to address their questions in a timely manner," president & CEO Mark Knudson said in prepared remarks. "We believe that the company continues on track for a panel in late Q4 2013/Q1 2014 with approval decision in the 1st half of 2014."

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EnteroMedics submitted its FDA application earlier this year, hoping to land indication to treat obesity, metabolic diseases and other gastrointestinal disorders. The Maestro system has been on the European market since winning CE Mark approval in 2011.