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.