PubMed

The Regulatory Perspectives on Endoscopic Devices for Obesity.

PMID: 28292410 · 2017

A, p, r, i, l, , K, , M, a, r, r, o, n, e, ;, , M, a, r, k, , J, , A, n, t, o, n, i, n, o, ;, , J, o, s, h, u, a, , S, , S, i, l, v, e, r, s, t, e, i, n, ;, , M, a, r, t, h, a, , W, , B, e, t, z, ;, , P, r, i, y, a, , V, e, n, k, a, t, a, r, a, m, a, n, -, R, a, o, ;, , M, a, r, t, i, n, , G, o, l, d, i, n, g, ;, , D, i, a, n, e, , C, o, r, d, r, a, y, ;, , J, e, f, f, r, e, y, , W, , C, o, o, p, e, r

학술지Gastrointestinal endoscopy clinics of North America

연도2017

PMID28292410

초록

The recent increase in US Food and Drug Administration-approved weight-loss devices has diversified obesity treatment options. The regulatory pathways for endoscopically placed weight-loss devices and considerations for clinical trials are discussed, including the benefit-risk paradigm intended to aid in weight-loss-device trial development. Also discussed is the benefit-risk analysis of recently approved endoscopic devices. A strategic priority of the FDA Center for Devices and Radiological Hea

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