Category: GI Dynamics
Aesthetics giant Allergan wins a panel date with the FDA for review of its Juv[eacute]derm Voluma XC dermal filler.
MASSDEVICE ON CALL — Aesthetic medical device maker Allergan (NYSE:AGN) will get a date with the FDA to review clinical data for the company's Juv[eacute]derm Voluma XC dermal filler.
Allergan hopes to win indication for deep implantation for aesthetic restoration in the face, according to the FDA notice.
Brazil's CMS Medical will be the exclusive distributor of GI Dynamics' weight loss and diabetes treatment, the EndoBarrier, once it wins regulatory approval from Brazil's watchdog agency.
GI Dynamics (ASX:GID) sealed a deal with CMS Medical to distribute its EndoBarrier weight loss and diabetes device in Brazil, hoping to hit the market there by early 2014.
The Israeli Ministry of Health OKs the EndoBarrier weight loss device made by GI Dynamics.
GI Dynamics (ASX:GID) earned a thumbs-up from the Israeli Ministry of Health for its EndoBarrie device to treat obesity and Type II diabetes.
Lexington, Mass.-based GI Dynamics said it's engaged \Lavi-Medical Agencies as exclusive distributor for the EndoBarrier in Israel, where Sheba Medical Center at Ramat-Gan is currently the only hospital offering the device.
GI Dynamics touts clinical research finding that its EndoBarrier gastrointestinal sleeve helps control blood sugar in "mildly obese" patients with Type II diabetes.
Medical device maker GI Dynamics (ASX:GID) touted newly published clinical trial data demonstrating that its EndoBarrier gastrointestinal implant can help control blood sugar levels as well as lower cholesterol in patients with Type II diabetes who are only "mildly obese."
GI Dynamics launches a U.S. trial of its EndoBarrier diabetes device, aiming to use the data to back a pre-market approval application with the FDA.
GI Dynamics (ASX:GID) said today that it's launched a U.S. pivotal trial of its EndoBarrier anti-diabetes weight loss device, hoping to use the study data to back a pre-market approval application with the FDA.
President & CEO Stu Randle told MassDevice.com that the Lexington, Mass.-based company hopes to put a PMA application before the federal watchdog agency "in late 2015."
GI Dynamics and W.L. Gore & Assoc. settle their long-standing patent beef over GID's EndoBarrier weight loss device.
A long-running dispute between W.L Gore & Associates and GI Dynamics (ASX:GID) is over after the medical device companies agreed to settle the beef.
GI Dynamics lands research partnerships with Medtronic and GlaxoSmithKline, evaluating the relationship between EndoBarrier intestinal liner treatment and patient glucose levels and hormonal changes.