In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

J&J Has A Plan B If Gamechanger Single Dose Vaccine Disappoints

If J&J’s gamble on a single dose pays off, it could rapidly advance the fight against SARS-CoV2 – but a second study will provide a safety net.

Woodcock To Be Acting US FDA Commissioner; Sharfstein Tops Biden's List Of Candidates For Post

Agency has been prepping Woodcock for the temporary task but what will happen to her role on Operation Warp Speed remains unclear. The move should give Biden team cushion to confirm a permanent leader of whom a top contender is former senior FDA staffer Joshua Sharfstein, a proponent of drug reforms that may irk manufacturers.

Topics

Related Companies

UsernamePublicRestriction

Register

ID1132542

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel