PureTech's Gelesis has moved into the U.S. with its pivotal trial for its Gelesis100. It's an oral capsule that contains small hydrogel particles, which are thought to bring to bear multiple mechanisms of action along the gastrointestinal tract to induce weight loss and improve glycemic control. But early clinical testing had a high placebo response that showed little differentiation between the Gelesis and placebo arms. The company dropped a proposed $32 million IPO late last year. The GLOW pivotal trial, that includes 125 patients, started in November 2014 in Europe. The placebo-controlled trial is slated to enroll 460 patients; it received a non-significant risk medical device study designation from the FDA in July 2015. More
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> Boston Scientific ($BSX) gained FDA approval for its ImageReady MR-Conditional Pacing System, a pacemaker that is safe for use during magnetic resonance imaging. More
> Novocure's ($NVCR) Optune to treat newly diagnosed and recurrent glioblastoma (GBM) patients is now in more than 360 U.S. cancer treatment centers. More
> The FDA has cleared the AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion System to treat atrial fibrillation. The next-gen system is designed to have improved capability to occlude the LAA in minimally invasive procedures. More