Science & Enterprise subscription

Follow us on Twitter

  • Change the name of the Washington NFL team? A respondent to @joshtpm has a brilliant idea ... Washington Dukes, for…
    about 41 mins ago
  • A medical software team designed a mobile app that records and analyzes a person's sounds and sleep positions to de…
    about 9 hours ago
  • New post on Science and Enterprise: Mobile App Screens for Sleep Apnea #Science #Business
    about 9 hours ago
  • Reported in Science & Enterprise on 6 May ... Coronavirus Testing the Cheap, Simple Way
    about 12 hours ago
  • A company discovering therapeutic antibodies identified antibodies considered particularly effective in neutralizin…
    about 1 day ago

Please share Science & Enterprise

FDA Approves 3-D Digital Mammography System

Hologic Inc., a developer of medical diagnostics and imaging products for women’s health care in Bedford, Massachusetts, says it has received an approval letter from the U.S. Food and Drug Administration (FDA) for the Selenia Dimensions three-dimensional digital mammography tomosynthesis system.

The Selenia Dimensions 3-D system is a new method for breast cancer screening and diagnosis. Breast tomosynthesis produces three-dimensional images which are intended to reveal the inner architecture of the breast, without distortions caused by tissue shadowing or density. Earlier mammography systems generate two-dimensional images.

FDA plans to conduct a review and inspection of Hologic’s manufacturing facility, methods, and controls before granting final pre-market approval of the system. The company says the Selenia Dimensions system is already available commercially outside the United States, including countries in Europe, Latin America and Asia. In North America, commercial systems are installed in Canada and Mexico.

*     *     *

Please share Science & Enterprise ...

Comments are closed.