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  • Regulatory NewsRegulatory News

    FDA Proposes Major Changes to Mammography Regulations

    The US Food and Drug Administration (FDA) on Wednesday proposed a new rule that would modernize mammography regulations and require mammography facilities to provide patients with more information on breast density. The changes come as, according to the National Cancer Institute (NCI), about 12.4% of women will be diagnosed with breast cancer at some point during their lifetime. In 2018, more than 260,000 women were diagnosed with breast cancer and more than 40,920 wome...
  • Regulatory NewsRegulatory News

    Screen-Film Mammography Will Soon be ‘Virtually Obsolete,’ FDA Says

    As quality issues with screen-film mammography continue to crop up, the US Food and Drug Administration (FDA) says facilities are almost done transitioning to full field digital mammography (FFDM) units 15 years after they came into clinical use. Currently, fewer than 400 screen-film units are in use at 5% of the facilities certified under the Mammography Quality Standards Act (MQSA). And although this represents just a sliver of the total mammography units in operation...