TransEnterix

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Devices & Diagnostics

Five tips on steering medical devices through the FDA

Millions of people use a 510(k) cleared medical device daily without even realizing the product has been evaluated by the Food and Drug Administration. It’s the toothbrush. The toothbrush is a a class I medical device, said Tammy Carrea, vice president quality and regulatory affairs for Durham, North Carolina medical technology company TransEnterix. Carrea uses […]