Experts raise concerns about delay in FDA's decision on FFDM systems

10/13/2009 | (free registration)

The mammography sector is still waiting for the FDA to act on a proposal that would reclassify full-field digital mammography systems from class III to class II devices, a move that would shorten the process of getting approval for new products. Industry experts think the three-year delay on the FDA rules is leading to higher prices of FFDM devices and limiting patients' access to innovations.

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