Duodenal mucosal resurfacing gains FDA breakthrough device designation for type 2 diabetes

Duodenal mucosal resurfacing gains FDA breakthrough device designation for type 2 diabetes

The FDA granted breakthrough device designation for a first-in-class duodenal mucosal resurfacing intervention for adults with insulin-treated type 2 diabetes, according to an industry press release.The duodenal mucosal resurfacing intervention (Revita DMR, Fractyl Laboratories) is an outpatient endoscopic therapy that uses heat to resurface the lining of the upper intestine. Fractyl’s preliminary clinical findings suggest that treatment with Revita DMR may decrease insulin resistance, improve glucose response, lower body weight and reduce liver fat.“We are thrilled to workRead More

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