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FDA concludes ReGen Biologics Inc. Menaflex device for knees should not have been approved

Last week the FDA announced that it would begin the process of rescinding approval of the Menaflex device designed to replace a torn medial meniscus.  The device is a "collagen scaffold" intended to improve the articulating surfaces of the joint, but the FDA announced in 2009 that its approval was "flawed" and would be renewed.  This month, the Food and Drug Administration explained that the approval was achieved through political pressure and the device should not have been approved under an expedited process applicable to devices that are "substantially similar" to devices previously approved.

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