Regulatory News In Brief
This article was originally published in The Gray Sheet
Hamburg touts FDA device review performance in closed-door Minneapolis meet-up last week with senators and industry. Other regulatory news items include a final rule on memoranda of understanding and a new panel meeting scheduled for Hologic’s first-in-class 3D mammography system.
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Hologic says it is impossible to predict how long it will take to secure reimbursement for its newly approved Selenia Dimensions three-dimensional digital mammography system.