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Trex Medical

This article was originally published in The Gray Sheet

Executive Summary

Full-field digital mammography system is found "not substantially equivalent" to film screen mammography systems, the company announces Aug. 6. The Thermo Electron subsidiary submitted additional data to FDA earlier this year after announcing that its 510(k) application had been withdrawn last December. The agency has indicated "several alternatives" to facilitate approval of the product and plans to discuss "the best possible use of the data" already collected in a meeting with Trex later this month. "We anticipate that design changes and additional clinical data are likely to be required," CEO Bill Webb notes

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