Health and Medical News and Resources

General interest items edited by Janice Flahiff

FDA reclassifies certain digital mammography devices

From a November 4, 2010 US Food and Drug Information (FDA) news release

 

For Immediate Release: November 4, 2010
Media Inquiries: Dick Thompson, 301-796-7566, dick.thompson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA reclassifies certain digital mammography devices
Devices capturing digital image of breasts to be Class II

The U.S. Food and Drug Administration today announced that it is easing the pathway to market for mammography systems that produce computerized X-ray images of the entire breast.
These systems, known as Full Field Digital Mammography Systems, are an alternative to mammography systems that produce X-ray film.
When first approved by FDA in 2000, digital mammography systems were categorized as a high risk or Class III device, because they were then considered novel systems for screening and diagnosing breast cancer.
Since then, digital mammography has been well-validated in scientific studies involving tens of thousands of patients. The benefits and risks of digital versus film mammography have also been well -described to physicians. As a result, the FDA has decided to reclassify digital mammography from Class III devices to Class II or medium risk devices…….

 

 

 

 

 

November 10, 2010 - Posted by | Uncategorized | , ,

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