Advertisement
News
Advertisement

FDA lowers regulatory hurdle for digital mammography

Thu, 11/04/2010 - 5:33pm
Diagnostic Imaging

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.

SOURCE

Topics

Advertisement

Share this Story

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading