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May 18, 2012 — The U.S. Food and Drug Administration (FDA) has published a draft guidance document entitled "Pediatric Information for X-ray Imaging Device Premarket Notifications."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 In the draft guidance, FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients.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 In addition to the draft guidance document, FDA has launched a Pediatric X-ray Imaging website that provides information on the benefits and risks of imaging using ionizing radiation,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

Video Plus Brochure Helps Patients Make Lung Cancer Scan Decision

Image courtesy of the American Thoracic Society

News | Lung Cancer | April 19, 2019
A short video describing the potential benefits and risks of low-dose computed tomography (CT) screening for lung...
FDA Clears GE's Deep Learning Image Reconstruction Engine
Technology | Computed Tomography (CT) | April 19, 2019
GE Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) of its Deep Learning Image...
Videos | RSNA | April 03, 2019
ITN Editor Dave Fornell takes a tour of some of the most interesting new medical imaging technologies displa
Four of the top pieces of content in March included news on proton therapy, including a 360 image and videos from ITN's recent visit to the Northwestern Medicine Proton Center in the Chicago suburbs. This image shows the main proton treatment room gantry at the proton center in Warrenville, Ill. Interview with Mark Pankuch, Ph.D.

Four of the top pieces of content in March included news on proton therapy, including a 360 image and videos from ITN's recent visit to the Northwestern Medicine Proton Center in the Chicago suburbs. This image shows the main proton treatment room gantry at the proton center in Warrenville, Ill.
 

Feature | April 02, 2019 | Dave Fornell, Editor and A.J. Connell
April 2, 2019 — Here is the list of the most popular content on the Imaging Technology News (ITN) magazine w
Johns Hopkins Medicine First in U.S. to Install Canon Medical's Aquilion Precision
News | Computed Tomography (CT) | March 26, 2019
March 26, 2019 — Johns Hopkins Medicine now has access to the first...
At #ACC.19, Siemens unveiled a version of its go.Top platform optimized for cardiovascular imaging. The newly packaged scanner can generate the data needed to do CT-based FFR (fractional flow reserve).

At #ACC.19, Siemens unveiled a version of its go.Top platform optimized for cardiovascular imaging. The newly packaged scanner can generate the data needed to do CT-based FFR (fractional flow reserve). Photo by Greg Freiherr

Feature | Cardiac Imaging | March 22, 2019 | By Greg Freiherr
Reflecting a trend toward the increased use of...
Researchers Use Radiomics to Predict Who Will Benefit from Chemotherapy
News | Radiomics | March 21, 2019
Using data from computed tomography (CT) images, researchers may be able to predict which lung cancer patients will...
HeartFlow Analysis Successfully Stratifies Heart Disease Patients at One Year
News | CT Angiography (CTA) | March 19, 2019
Late-breaking results confirm the HeartFlow FFRct (fractional flow reserve computed tomography) Analysis enables...
SyncVision iFR Co-registration from Philips Healthcare maps iFR pressure readings onto angiogram.

SyncVision iFR Co-registration from Philips Healthcare maps iFR pressure readings onto angiogram. Results from an international study presented at #ACC19 show that pressure readings in coronary arteries may identify locations of stenoses remaining after cardiac cath interventions.

Feature | Cardiac Imaging | March 18, 2019 | By Greg Freiherr
As many as one in four patients who undergo cath lab interventions can benefit from a technology that identifies the
Jennifer N. A. Silva, M.D., a pediatric cardiologist at Washington University School of Medicine in Saint Louis, Mo., describes “mixed reality” at ACC19 Future Hub.

Jennifer N. A. Silva, M.D., a pediatric cardiologist at Washington University School of Medicine in Saint Louis, Mo., describes “mixed reality” at ACC19 Future Hub.

Feature | Cardiac Imaging | March 17, 2019 | By Greg Freiherr
Virtual reality (VR) and its less immersive kin, augmented reality (AR), are gaining traction in some medical applica