News | May 18, 2012

FDA Asks Industry to Consider Pediatric Patients When Designing Imaging Systems

May 18, 2012 — The U.S. Food and Drug Administration (FDA) has published a draft guidance document entitled "Pediatric Information for X-ray Imaging Device Premarket Notifications." The document encourages manufacturers to consider the safety of children in the design of new X-ray imaging devices. In the draft guidance, FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients. It also proposes that manufacturers who do not adequately demonstrate that their new X-ray imaging devices are safe and effective in pediatric patients include a label that cautions against use in pediatric populations.

The guidance is part of FDA’s “Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging,” launched in February 2010. In addition to the draft guidance document, FDA has launched a Pediatric X-ray Imaging website that provides information on the benefits and risks of imaging using ionizing radiation, recommendations for parents and healthcare providers to help reduce exposure to unnecessary radiation exposure, and information for manufacturers of X-ray imaging devices. Additionally, FDA is collaborating with the Alliance for Radiation Safety in Pediatric Imaging (ARSPI) and manufacturers, through the Medical Imaging and Technology Alliance (MITA), on developing pediatric imaging radiation safety training materials.

For more information: www.fda.gov/Radiation-EmittingProducts/default.htm

Related Content

Researchers Awarded 2018 Canon Medical Systems USA/RSNA Research Grants
News | Radiology Imaging | November 13, 2018
The Radiological Society of North America (RSNA) Research & Education (R&E) Foundation recently announced the...
The Fujifilm FCT Embrace CT System displayed for the first time at ASTRO 2018.
360 Photos | 360 View Photos | November 07, 2018
Fujifilm's first FDA-cleared compu...
MaxQ AI Receives FDA Clearance for Accipio Ix Intracranial Hemorrhage Platform
Technology | Artificial Intelligence | November 07, 2018
MaxQ AI announced that its Accipio Ix intracranial hemorrhage (ICH) detection software has received 510(k) clearance...
Charles Ananian, M.D.

Charles Ananian, M.D.

Sponsored Content | Case Study | Digital Radiography (DR) | November 07, 2018
Whether it’s a premature baby or a critically ill child, treating little patients is a huge responsibility.
GE Healthcare Discovery RF Gen 2 system displayed at ASTRO 2018. It is a dedicated computed tomography (CT) scanner for radiation oncology
360 Photos | 360 View Photos | November 07, 2018
This is the GE Healthcare Discovery RF Gen 2 system displayed at the ...
Results of the vertebrae-based analysis (383 vertebrae in 34 patients) for detection of BME.

Results of the vertebrae-based analysis (383 vertebrae in 34 patients) for detection of BME.

Sponsored Content | Case Study | Computed Tomography (CT) | November 06, 2018
The following is a summary of a study published in the
The NeuViz 16 Essence from Neusoft Medical Systems.

The NeuViz 16 Essence from Neusoft Medical Systems.

Feature | Computed Tomography (CT) | November 05, 2018 | By Melinda Taschetta-Millane
According to an industry mark...
Carestream Spotlights Healthcare IT and Imaging Systems at RSNA 2018
News | Information Technology | October 31, 2018
Carestream announced it will be displaying several imaging and healthcare information technology (IT) offerings at the...
IMRIS, Siemens Strengthen Collaboration in Hybrid OR Neurosurgical Market
News | Hybrid OR | October 24, 2018
IMRIS, Deerfield Imaging, in partnership with Siemens Healthineers, announced a strengthened collaboration to advance...
Fujifilm Unveils FCT Embrace CT System for Oncology
Technology | Computed Tomography (CT) | October 23, 2018
Fujifilm Medical Systems U.S.A. Inc. recently introduced the FCT Embrace computed tomography (CT) system. Powered by...