The number of “novel” medical devices that hit the market in 2018 surpassed the 98 devices that were approved in 2017 by eight.
The Food and Drug Administration announced that 106 novel devices—such as the world’s smallest heart valve for newborns and the first blood test to evaluate mild traumatic brain injury—were approved last year.
Novel device approvals have grown significantly since 2009, when only 25 devices cleared using a process that doesn’t compare the product to previous versions, according to the FDA. There’s been steady use of this regulatory pathway, which is intended to spur innovation among manufacturers. For...
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