Study: Valves, stents often win FDA nod without proof they improve care

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New heart devices--including valves and stents--gain FDA approval without solid studies that show they are an improvement over the existing standard of care, according to a new study published in the Journal of the American Medical Association and highlighted by Reuters. The FDA does require trials with control groups for first-of-its-kind devices, the article notes, but devices that resemble ones already on the market gain approval without the control comparison. Regulators say the added requirement could delay getting updated devices to patients, Reuters notes. But the study authors argue that the control comparison could help boost safety by establishing whether a device is truly better than a predecessor product. Story