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Medical Device Innovation Leadership

Trex Medical's Story

Executive Summary

Trex Medical got a bit of good news in February, when the FDA said that it considers the company's 510K submission for clearance of a digital mammography system to be active. That may not seem like much, but the company's been in a lot of hot water lately. In December, much to the surprise of many, the FDA rejected the company's initial application for its digital mammography system, saying the data didn't support the company's contention that its digital mammography equipment was equivalent to standard mammography. Then, the company had to restate its fourth quarter and year-end results and its long-time CEO, Hal Kirshner, resigned. A new CEO was appointed in January, Michael Webb, a former Picker International executive.
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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