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For the vast majority of medical imaging devices, passing FDA review is a snap: Show equivalence to a device already on the market, wait a few months, and release the announcement that your new product is ready for U.S. patients. But not for full field digital mammography systems.

Since the first FFDM – the GE Senographe 2000D – passed FDA muster nearly 11 years ago, every FFDM device has had to go through the premarket approval system, a lengthy and often torturous process akin almost to the drug approval process.

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