Tag: mesh-devices
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FDA tightens clinical requirements for transvaginal devices
(Reuters) – The U.S. Food and Drug Administration said on Monday it had taken steps to strengthen the data requirements for surgical mesh devices when used to repair pelvic organ prolapse (POP) via the vagina. Over the past several years, the FDA has received thousands of reports of complications, including bleeding, organ perforation and urinary…
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First-of-a-kind drug approvals continued rise in 2015
WASHINGTON (AP) — Approvals for first-of-a-kind drugs climbed last year, pushing the annual tally of new U.S. drugs to its highest level in 19 years.