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.
Trex Medical Corp. , a leading provider of mammography and X-ray equipment, 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, except that the company has been in so much hot water lately.
Only last December, the agency categorized the filing for digital mammography, which Trex submitted more than a year ago, to...
Bristol Myers Squibb executive Doxie Jordan discusses his path to global commercial leadership and the principles guiding pharmaceutical market strategy
Devika Wood, CEO of Brain+, explains the importance of developing health tech solutions for dementia and the growing need to both raise awareness and improve overall access to nondrug interventions like CST.
In a challenging funding environment for biopharma, strategic dealmaking has become a critical growth engine. In Vivo explores what it truly takes to navigate high-stakes acquisitions and partnerships, drawing on insights from seasoned industry leaders.
