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)...

The fourth quarter proved to be challenging for Novartis, with its dermatology, ophthalmology and oncology products – and Zolgensma – feeling the impact of COVID-19 lockdowns. The company is hoping for much better things in the second part of 2021.