FDAnews Device Daily Bulletin

The House will use an open amendment process for H.R. 5973, the bill that includes the FDA’s fiscal 2013 appropriations, requiring amendments to be offered on the House floor during the bill’s reading, the House Rules Committee says.

Implementing a new labeling requirement by the EU’s Central Management Committee (CMC) on Medical Devices will raise devicemakers’ costs without any benefit to patient safety, industry association Eucomed says.

Indiana’s medical device and orthopedics industry will continue to fight against a tax on its products after the U.S. Supreme Court upheld the tax as part of a broader affirmation of the federal healthcare overhaul.

Burlington-based medical device company Infraredx said it has signed an exclusive five-year agreement with Nipro to distribute the company’s TVC Imaging System in Japan.

The future of prostate cancer therapy may lie in a tiny, “sticky” silicon chip dubbed GEDI (Geometrically Enhanced Differential Immunocapture) that can identify and collect cancer cells from a patient’s bloodstream.

FDA approved Beckman Coulter’s Prostate Health Index (phi) blood test for detecting prostate cancer in patients with PSA values in the 4–10 ng/mL range.

Nanosphere said that it has received de novo clearance from the FDA to market its Gram-Positive Blood Culture Nucleic Acid Test on its Verigene System.

Advanced visualization software developer Intrinsic Medical Imaging has received FDA 510(k) clearance for its IMI Spectrum 3-D imaging workstation software.