Allurion Technologies (ALUR) announced topline results from the AUDACITY FDA pivotal trial evaluating the safety and efficacy of the Allurion Balloon. The AUDACITY trial is an open-label ...

The AUDACITY trial is an open-label, multicenter, randomized, controlled study and is the first FDA pivotal trial on an intragastric balloon for weight loss to report primary outcomes beyond 9 months.

The AUDACITY trial achieved its responder rate co-primary endpoint by demonstrating that more than 50% of Allurion Balloon subjects lost more than 5% of their total body weight at 48 weeks (58% ...