Internal records point to leniency in device approvals at FDA

01/14/2009 | Wall Street Journal (free content), The ·

An FDA supervisor overruled agency scientists to speed up the approval of iCAD SecondLook Digital Computer-Aided Detection System for Mammography -- a device used with screening tools from Fujifilm Medical Systems -- after getting a phone call from former Rep. Christopher Shays, R-Conn., according to agency documents. Shays said he asked for a final decision and not clearance for the product. A FujiFilm Medical spokeswoman said the firm sought the help of "local congressional offices" to get clarification on the FDA review process.

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