Scrip 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

Hologic Mammography Device Revenue Erodes In Recession

This article was originally published in The Gray Sheet

Executive Summary

Hologic is reducing its fiscal 2009 revenue guidance by about 10% to account for the recession's effect on mammography product sales

You may also be interested in...



Hologic Expects 2010 Launch Of Tomosynthesis System After FDA Panel Delay

Hologic is now forecasting a late 2010 launch of its Selenia Dimensions tomosynthesis three-dimensional mammography system, after recent discussions with FDA led the firm to back out of a planned June advisory panel review

Hologic Expects 2010 Launch Of Tomosynthesis System After FDA Panel Delay

Hologic is now forecasting a late 2010 launch of its Selenia Dimensions tomosynthesis three-dimensional mammography system, after recent discussions with FDA led the firm to back out of a planned June advisory panel review

RSNA 2008 Annual Meeting In Brief

Hologic's tomosynthesis: New data presented at Radiological Society of North America conference in Chicago on Dec. 2 shows Hologics' tomosynthesis breast mammography system Selenia Dimensions has a lower recall rate than traditional mammography and can detect tumors in dense breasts. The Selenia Dimensions takes a series of images to show tissue structure in three dimensions, allowing physicians to see an anomaly in breast tissue from multiple angles. Hologic originally expected FDA to approve the PMA for Selenia Dimensions in the second quarter of 2008, but FDA approval for the device was pushed back by a July 30 letter from the agency, requesting additional information (1"The Gray Sheet" Jan. 21, 2008, p. 7). FDA will likely convene an advisory panel meeting to review the PMA. Selenia Dimensions received a CE mark in Europe during the firm's fourth fiscal quarter of 2008. "We continue to see approval as when, not if," Morgan Stanley analyst David Lewis writes in a Dec. 4 report on tomosynthesis. "Focus will eventually turn to the technology, which has garnered considerable physician interest as a revolution versus digital, although concerns on adoption, workflow and applicable market exist.

Related Content

Topics

UsernamePublicRestriction

Register

MT027084

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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