GAITHERSBURG, Maryland — The FDA hearing on exposure to ionizing radiation in imaging scans included a roster of speakers who addressed a series of issues, but one theme emerged that gave both the agency and industry something to think about: several physicians who spoke bluntly informed both the agency and CT makers that they are not qualified to tell a doctor who should and should not get a scan, and furthermore that they are also not qualified to dictate dose. (Medical Device Daily)

GAITHERSBURG, Maryland – For the second time in 16 months, the orthopedics and rehabilitative devices advisory committee met to hear the case for and against the Menaflex 510(k), an application that in some minds is the poster child for all that is presumed to be wrong with the 510(k) process. (Medical Device Daily)

The U.S. House of Representatives passed the landmark Patient Protection and Affordable Care Act of 2010 (H.R. 3590) late Sunday night by a vote of 219-212, earning just three votes more than the bare minimum needed for passage, and the majority party enjoyed a similar margin in passing the technical amendments in the form of H.R. 4872, dubbed the Health Care and Education Affordability Reconciliation Acts. (Medical Device Daily)