More than 4 million mammograms will be performed in the United States this year. The market for mammography equipment in this country, currently estimated at approximately $160 million, is expected to grow at a rate of 20% per year over the next five years, with sales expected to reach $340 million by 2005.
Kathleen M. Dallessio
More than 4 million mammograms will be performed in the United
States this year, according to an article published in the
June/July 2001 issue of
. The market for mammography equipment in this country, currently
estimated at approximately $160 million, is expected to grow at a
rate of 20% per year over the next 5 years, with sales expected to
reach $340 million by 2005. Fueling this growth are several newly
available technologies, full-field digital mammography (FFDM) and
computer-aided detection (CAD). Also expected to contribute to this
increase is optical imaging of the breast using computed
tomography, technology that is not yet available in the United
Computed tomography laser mammography
Imaging Diagnostic Systems (Plantation, FL) appears to have the
lead in the commercial development of CT laser mammography. In
fact, the company recently received CE marking and an ISO 9002
approval to market their optical system, the Computed Tomography
Laser Mammography (CTLM) system, in Europe. In the United States,
the company has submitted all four modules for pre-market
authorization (PMA) to the Food and Drug Administration (FDA) and
has received approval for the first two modules. Clinical trials
are currently under way at The University of Virginia and Nassau
County Medical Center in New York.
In an interview with
, David Richter, MD, Medical Director at Imaging Diagnostic,
explained how the CTLM works. "The CT Laser Mammography machine
uses laser lights instead of x-ray, and, like any CT modality, it
gives us the ability to make slices throughout the breast," he
said. "The software then summarizes the data and gives us the
ability to create a lateral view, a craniocaudal view, and a
coronal view of the breast. It then can take all this information
and make a 3D image of the breast, localizing exactly where the
tumor is, if one is present."
The entire exam takes approximately 15 to 20 minutes, depending
upon breast size, and is performed with the patient lying face down
on a table and without compression of the breast tissue. The images
are available within minutes, since the system processes one slice
as the next is being obtained, Richter explained. The
DICOM-compatible system also features CD-ROM image storage and a
CD-ROM atlas of cases.
Richter cited several preliminary findings from the early
trials. "For example," he noted, "what we are finding in cases of
ductal carcinoma in situ is that: 1) the size of the tumor does not
necessarily correspond with the size expected from the
calcifications in the breast; and 2) in many cases, we can actually
predict that the carcinoma in situ really has areas of invasive
cancer in it" (figure 1).
He also noted that initial studies have shown that women with
breast implants and those with dense breasts can be scanned better
using the CTLM than with other modalities. "Since our findings are
really based on increased vascularity and tumor angiogenesis, areas
with implants obviously have no vessels in them, so they don't
interfere with our scans," he explained. "The same thing seems to
be true with the density of the breast; whether it is a dense
breast or a fatty breast, the image is the same." He also noted
that because there is no ionizing radiation involved, this scan can
be repeated as often as necessary, which may be an important factor
for patients who require repeated exams.
"At the moment, we are saying that we are an adjunct to
mammography," said Richter. "This would be used much the same way
as MRI and ultrasound are used right now in breast imaging."
The ongoing clinical trials focus on patients with Breast
Imaging and Reporting Data Systems (BIRADS) classification in
categories 3 and 4. "Quite frankly, there is no reason to do a test
like ours, or any other adjunct test, in most BIRADS 5 cases," said
Richter. "It is fairly obvious that those are going to be biopsied
and additional studies don't really help." He said the goal at this
point is for the CTLM system to identify the BIRADS 3 case that
will turn out to be cancer, which may shorten the time to
Roughly 80% of BIRADS 4 cases are benign, and one of the goals
of the system is to eliminate some of the BIRADS 4 cases that are
biopsied. "We understand that it will take time before people have
confidence in our machine and before they are willing to accept the
results," Richter acknowledged, "but eventually that would be one
of our goals."
Richter credited Imaging Diagnostic Systems' CEO Richard Grable
with the creation of this system. Mr. Grable passed away on August
13 of this year. "This whole project was his dream. He truly
dedicated the later years of his life to developing this. It's
really one man's vision with the work of a lot of experts in every
different field. He really was a remarkable man."
For a more in-depth look at this technology, see Grable R,
Gkanatsios NA, Ponder SL. Optical mammography.
. 2000;29(2): 18-20, which is available at
Full-field digital mammography
Another technology currently fueling the rapid growth in the
mammography market is full-field digital mammography (FFDM). Two
companies have recently unveiled plans to enter this growing
Fisher Imaging (Denver, CO) recently announced that they had
received an approvable letter from the FDA on its PMA application
for the SenoScan digital mammography system. The company expects to
receive final marketing approval in the coming weeks. Once
approved, Fisher Imaging will join GE Medical Systems (Milwaukee,
WI) as the only companies with FFDM systems available in the United
This new system, with a 22-X 30-cm field of view, generates a
25-micron pixel size in high-resolution mode, and a 50-micron size
in standard-resolution mode. Its detective quantum efficiency (DQE)
is 50% at zero spatial frequency, and it has a limiting resolution
of 10 line pairs/mm at standard resolution, and 16 line pairs/mm at
Further back in the developmental pipeline, Eastman Kodak Health
Imaging (Rochester, NY) unveiled an amorphous selenium-based FFDM
system as a work-in-progress at the 2001 American Healthcare
Radiology Administrators (AHRA) meeting in Las Vegas, NV. The
system is based on the same technology used in the company's line
of digital radiography systems for general radiography, although a
new source of amorphous selenium is used in the FFDM system. The
company reports that the new material produces an 85-micron pixel
pitch, and demonstrates significantly less noise in the amorphous
selenium-based images when compared with similar images taken from
amorphous silicon and charge-coupled device technologies.
The system, which will feature computer-aided detection (CAD)
capabilities, is expected to include an x-ray generator, a digital
detector, an operator console, a digital storage unit, and a
DryView 8610 laser imager for printing images.
The system is currently undergoing prototype trials, with
clinical trials slated to begin at three locations in late 2002.
Kodak has not yet applied for a PMA.
Mammography reimbursement issues
Regulators recently recommended that reimbursement for
mammographic exams should be increased to more accurately reflect
the amount of work required to obtain these studies.
The Relative Value Update Committee (RUC) of The Centers for
Medicare and Medicaid Services (CMS, formerly HCFA) has recommended
an increase of 15% for bilateral exams and 18% for unilateral
exams, according to reports published in the June 8, 2001 issue of
. The RUC also recommended acceptance of changes in the current
procedural terminology (CPT) codes as proposed by the American
College of Radiology.
In other reimbursement news, a category 1 CPT code has been
approved for the use of R2 Technology's ImageChecker CAD system
(Los Altos, CA). The new code is considered an "add-on" because the
product is used as a supplement to screening mammography.
Both of these changes are expected to be included in the
American Medical Association's CPT 2002 codebook, scheduled for
publication in November 2001.
Beekley introduces S-SPOT for marking scars
Beekley (Bristol, CT) recently introduced the Soft 'N Stretchy
S-SPOT skin marker for localizing previous scar tissue during
mammographic exams. The elasticity of the S-SPOT is designed to
ensure that the marker stays in place while moving with the breast
as it is manipulated during the exam.