[Reblog] My talk to Knight Science Journalism Fellowships at MIT Medical Evidence Boot Camp 2013

From the 8 December 2013 post at HealthNewsReview.org

Last week in Cambridge, I spoke again (5th time?) at this event.  Always an honor.   Always a smart audience.

Thanks to Phil Hilts for the invitation and the opportunity to share our work with a new group of journalists.

Here are my slides.

Some excerpts

Related articles

• The Mammogram Myth, Alive and Well on “Good Morning America” (psychologytoday.com)
• Health Studies: Fact or False Hope? (kstp.com)

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…….

…

For more information:

Federal Register Notice

Mammography

Special Controls Guidance

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