Quantib Blog A 101 on the new FDA guidance for the approval of quantitative radiological products

In June 2022, the Food and Drug Administration (FDA) published a Guidance document1 to serve manufacturers of radiological devices as guidance when filling in their premarket submissions for such devices if they include quantitative imaging functions. We have summarized this guidance to give manufacturers and radiologists a clear overview of the Guidance’s content and the impact is may have on the industry.