US approves first 3-D mammogram
Monday 14 February 2011
The first three-dimensional mammogram device was approved Friday by the US Food and Drug Administration, in the hopes that the new technology would improve early breast cancer detection.
Currently the only technology on the market produces two-dimensional X-ray images of the breast.
"Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.
A pair of studies reviewed by the FDA showed a seven percent improvement in the ability of radiologists to "distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone," the regulatory agency said.
The new device, called the Selenia Dimensions System, is made by the Massachusetts-based company Hologic and functions as an upgrade to its current 2-D FDA approved system.
The new technology "produces three-dimensional images which are intended to reveal the inner architecture of the breast, free from the distortion typically caused by tissue shadowing or density," the company said in a statement.
"The examination, which includes a 3-D tomosynthesis image in combination with a 2-D image, takes only seconds longer than a conventional 2-D digital mammogram at a total exam dose within current FDA guidelines."
The FDA said the time it takes to capture the 2-D and 3-D images "approximately doubled the radiation dose the patient received" but that any additional risk was believed to be low.
"There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having both a 2-D and 3-D exam is expected to be less than 1.5 percent compared to the natural cancer incidence, and less than one percent compared to the risk from conventional 2-D mammography," the FDA said.
The US agency also noted the 3-D approach "improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic workup."
The National Cancer Institute recommends that women over 40 get mammograms to screen for breast cancer every one or two years.
Hologic stock rose just over two percent following the FDA approval.
Life & Style blogs
Three in every four British men will be overweight by 2030, says World Health Organisation
Rihanna's Met Gala dress took one Chinese woman 2 years to make, was reduced to omelette meme in 2 seconds
Women think Irish men are the sexiest, survey finds
How to gain confidence and maximise your sexual potential
What do the emoji on Snapchat mean?
- 1 Katie Hopkins gives rare glimpse of sensitive side with heartfelt open letter to her children penned in case she dies from epilepsy
- 2 Rihanna's Met Gala dress took one Chinese woman 2 years to make, was reduced to omelette meme in 2 seconds
- 3 Top Gear: Jodie Kidd, Philip Glenister and Guy Martin 'in advanced talks' to replace Jeremy Clarkson and co
- 4 Women think Irish men are the sexiest, survey finds
- 5 Florida couple forced to register as sex offenders for having sex on public beach
£35000 - £40000 per annum + car and benefits: Ashdown Group: Marketing Manager...
£18000 - £20000 per annum: Ashdown Group: Helpdesk Analyst - Devon - £20,000 ...
£35000 - £50000 per annum + generous bonus: Ashdown Group: Business Analytics ...
£45000 - £50000 per annum: Ashdown Group: IT Project Coordinator (Software Dev...