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.
You may also be interested in...
In Women's Health, Hologic Stays Ahead of the Curve
Hologic is garnering more attention these days than it might have in the past because it's just come off an "annus mirabilis." In 2006, Hologic made three vertical acquisitions in the area of breast cancer detection, and it reported stellar financial results. The company is now a market leader in osteoporosis assessment and has an approxmately 50% share of the conventional mammography customer base as well as an early lead in digital mammgoraphy, which is remarkable considering that it is a mid-sized company competing in capital equipment markets against the likes of GE and Siemens.
The Next Big Thing In Gene Therapy Might Not Be Gene Therapy
Gene therapy remains attractive when data show new technologies can advance the field, but gene regulation, editing and RNA therapies are grabbing investors’ attention, panelists said at ARM’s Cell and Gene Meeting on the Mesa.
Gilead Sees Room For Trodelvy In European Markets
Gilead looks set to expand its lead position in the triple-negative breast cancer (TNBC) market in Europe with a positive opinion for Trodelvy from the CHMP.