Hologic Lorad Selenia
This article was originally published in The Gray Sheet
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'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
Second read-out maintains 94% level of efficacy, with a very early signal that it could outperform Pfizer’s rival mRNA candidate in preventing severe cases.
Russia says it will make the first deliveries of its $10-per-dose Sputnik V vaccine in January, while international regulators say vaccine trials should continue for as long as possible to generate longer-term evidence on their benefits and risks. A UK research body has stressed that drugs repurposed for COVID-19 also need to undergo thorough safety and efficacy testing as reports suggest the UK regulator could approve a vaccine within days.