General Electric Co. won approval from the Food and Drug
Administration to offer its 3-D breast-imaging technology in the
U.S., the company said, adding substantial new competition to the
fast-growing market dominated by Hologic Inc.
Three-dimensional imaging--also known as tomosynthesis--combines
X-rays taken from multiple angles to produce a more detailed
picture than regular mammograms. The technology costs more than
regular mammography, but finds more cancers with fewer false
alarms, studies have found, and is rapidly replacing the
traditional mammography in the $10 billion-a-year market for breast
screenings.
Insurers and Medicare don't provide extra reimbursement for 3-D
mammograms. Some hospitals charge patients extra for it--generally
$50 to $75 per exam; other hospitals absorb the extra cost of the
machines.
Hologic, which has had the sole approved 3-D breast-imaging
device in the U.S. since 2001, estimates that more than six million
U.S. women will have a 3-D mammogram this year, about 17% of all
those screened. About 1,100 hospitals and imaging centers in the
U.S. have purchased at least one 3-D Hologic system, that company
has said.
GE said about half of the 4,000 GE breast-imaging devices in use
in the U.S. can be upgraded to use its 3-D system, called
SenoClaire. Even though the system takes images from nine different
angles, patients receive the same dose of radiation as with a
regular 2D mammogram, the company said.
Hologic's 3-D system won FDA approval for use along with a
standard 2D mammogram, which can increase the radiation dose.
Hologic says its system's radiation dose is below government safety
standards, and that 30% of its U.S. sites now use its new low-dose
device that is comparable to conventional mammography.
Peter J. Valenti III, president of Hologic's breast-health
division, also noted that a major clinical trial, published in the
Journal of the American Medical Association in June, found that 3-D
mammography technology increased invasive breast cancer detection
by 41%, and decreased recalls by 15%, applied only to its device,
and not GE's system.
Siemens AG filed for FDA approval of its 3-D system in late June
and was unavailable for comment.
Rachael Bennett, a clinical analyst at MDBuyline, a
health-research firm, said many hospitals had purchased Hologic
equipment in recent years because it was the only 3-D
breast-imaging system available, but others have been holding back,
waiting for SenoClaire to win FDA approval.
"We may see a big influx of GE purchases," she said. The
competition will give hospitals that want to purchase 3-D systems
added negotiating power, she added.
Medicare may indicate later this year whether it will provide
extra reimbursement for 3-D mammography. But even without it, the
technology is fast overtaking regular scans. "Almost all the
hospital purchases we're seeing are for tomosynthesis systems or
systems that can be upgraded later," said Ms. Bennett.
Write to Melinda Beck at HealthJournal@wsj.com
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