Hologic Lorad Selenia
This article was originally published in The Gray Sheet
Executive Summary
PMA supplement approval of the second-generation full-field digital mammography system for screening and diagnosis of breast cancer is announced Oct. 2. Shipments of the system, which uses Hologic's DirectRay amorphous-selenium, direct-to-digital image receptor technology, will begin by year-end. The technology also will be available as a field upgrade for the 3,000 Lorad M-IV screen-film systems. Hologic's first-generation Lorad FFDM system, using charge-coupled device (CCD) technology, was approved by FDA in March (1"The Gray Sheet" March 25, 2002, p. 13)...
You may also be interested in...
Hologic To Delay Digital Mammography Launch Pending Selenia Approval
Hologic's Selenia digital mammography system for breast cancer screening and detection should receive FDA market go-ahead by year-end, the firm claims. A PMA supplement for the second-generation digital mammography system, which incorporates proprietary amorphous selenium DirectRay technology, will be filed shortly
AAM Welcomes Proposal To Update Medicare Part D
After urging the US Congress to act on updating Medicare Part D, the Association for Accessible Medicines has welcomed the decision to update Part D by the Centers for Medicare & Medicaid Services of the US Department of Health and Human Services.
Dr Reddy’s Wants To Break Into Top Five In India
Dr Reddy’s signals a sharp step up in ambitions at home, propelled by building leadership in 10 therapy segments and an “India-first” approach for specialty products. Uptick in the China business and the potential launch of a Russia-partnered COVID-19 vaccine were other aspects of the business discussed at JPM.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: