FDA approves Siemens system for 3-D-only mammography
por Lauren Dubinsky, Senior Reporter | May 18, 2016
Medical Devices
Women's Health
X-Ray
Siemens' MAMMOMAT Inspiration
If a physician wanted to screen their patients with breast tomosynthesis, or 3-D mammography, they had to also screen them with 2-D mammography, but that’s no longer the case. Siemens Healthineers announced today that the FDA has approved the use of 3-D-only screening mammography with its Mammomat Inspiration with Tomosynthesis Option digital mammography system.
“If we can eliminate one of the image tools and have patients get 3-D alone, from a radiologist’s perspective there are less images for them to read so there is higher efficiency,” Jenn Okken, women’s health product manager at Siemens, told HCB News.
This is the first and only 3-D digital breast tomosynthesis system to receive FDA approval as a stand-alone screening and diagnostic tool. The other systems on the market — Hologic’s Selenia Dimensions mammography system and GE Healthcare’s SenoClaire 3D Breast Tomosynthesis system — require a combination of 2-D and 3-D examinations.
“Their devices are completely different, so they wouldn’t be able to at this point prove that their technology could stand alone in a 3-D environment,” said Okken.
The approval was based on a pivotal reader study in which the participating radiologists read 3-D-only images and then 2-D and 3-D images to determine how well they could detect cancer. The study found that the radiologists were able to decrease average recall rates by an average of 19 percent without a 2-D image.
“What we were able to prove in this study was that we saw more cancers and reduced recalls, but additionally we took away all of the dose that’s given to patients with 2-D mammography today,” said Okken.
New evidence is continually emerging to define the benefits of tomosynthesis. A study published last month in JAMA determined that the modality is effective in diagnosing cancer in dense breasts — something 2-D mammo has been less successful with.
"Our study answered the critical question of who should be imaged with tomosynthesis, providing compelling evidence that all women undergoing mammographic screening should be imaged with tomosynthesis, regardless of their breast density," Dr. Elizabeth Rafferty, the lead investigator of that study, told HCB News.
Other researchers exploring solutions for dense breast diagnosis have weighed tomosynthesis against ultrasound as secondary imaging modalities to 2-D mammography. They found that although ultrasound detected more cancers, it also generated significantly more false positives.
“If we can eliminate one of the image tools and have patients get 3-D alone, from a radiologist’s perspective there are less images for them to read so there is higher efficiency,” Jenn Okken, women’s health product manager at Siemens, told HCB News.
This is the first and only 3-D digital breast tomosynthesis system to receive FDA approval as a stand-alone screening and diagnostic tool. The other systems on the market — Hologic’s Selenia Dimensions mammography system and GE Healthcare’s SenoClaire 3D Breast Tomosynthesis system — require a combination of 2-D and 3-D examinations.
“Their devices are completely different, so they wouldn’t be able to at this point prove that their technology could stand alone in a 3-D environment,” said Okken.
The approval was based on a pivotal reader study in which the participating radiologists read 3-D-only images and then 2-D and 3-D images to determine how well they could detect cancer. The study found that the radiologists were able to decrease average recall rates by an average of 19 percent without a 2-D image.
“What we were able to prove in this study was that we saw more cancers and reduced recalls, but additionally we took away all of the dose that’s given to patients with 2-D mammography today,” said Okken.
New evidence is continually emerging to define the benefits of tomosynthesis. A study published last month in JAMA determined that the modality is effective in diagnosing cancer in dense breasts — something 2-D mammo has been less successful with.
"Our study answered the critical question of who should be imaged with tomosynthesis, providing compelling evidence that all women undergoing mammographic screening should be imaged with tomosynthesis, regardless of their breast density," Dr. Elizabeth Rafferty, the lead investigator of that study, told HCB News.
Other researchers exploring solutions for dense breast diagnosis have weighed tomosynthesis against ultrasound as secondary imaging modalities to 2-D mammography. They found that although ultrasound detected more cancers, it also generated significantly more false positives.
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