Research and Development
The FDA, with partners in academia and industry, is pursuing research in:
- metrics for image quality, which are crucial to the evaluation of risk (dose) vs. benefit (image quality) in radiological device submissions; and
- methods for more accurate quantification of the dose received from CT and other X-ray imaging procedures.
Examples of FDA's image quality and dose assessment research activities include:
- developing improved physical and computerized "phantoms" which can be used in assessment of image quality and dose;
- accelerating computer simulations to allow for fast simulation of X-ray image data and real-time estimation of radiation dose; and
- estimating organ doses to patients undergoing CT scans.
As new science and methods are developed, FDA also promotes development of national and international standards that can be used in FDA's evaluation of device safety and effectiveness. For example, the FDA is currently working with MITA to develop methods for estimating the dose reductions that can be achieved using iterative image reconstruction algorithms.
The National Institutes of Health (NIH) and Coalition for Imaging and Bioengineering Research (CIBR) sponsored, with support from FDA, the American College of Radiology, and the American College of Cardiology, "The Summit on Management of Radiation Dose in Computerized Tomography: Toward the Sub-mSv Exam" (February 24-25, 2011). This workshop brought together academic researchers, professional organizations, industry, and government agencies to explore possible research directions in radiation dose optimization for CT.
For more information on FDA research efforts, please refer to CDRH’s Division of Imaging and Applied Mathematics webpage.