Novel ingestible device cleared by FDA for weight management
The U.S. Food and Drug Administration announced the clearance of a novel ingestible device to help adults with a body mass index of 25 to 40 kilograms per meter squared manage their weight.
The clearance comes after positive findings from the prospective multicenter RESET trial, in which 279 adult patients were randomly assigned to receive either the ingestible device or placebo twice weekly for 24 weeks.
Compared with those who received placebo, the patients who received the ingestible device experienced greater weight reduction, higher response rates and an improved quality of life. There were no serious adverse effects reported in the ingestible device group.
Researchers hope the new device can help broaden the patient population eligible for this type of intervention. The FDA noted that the novel device is intended to be used in conjunction with a diet and exercise regimen.
Read more: PR Newswire
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