• 宣布 DOTmed‘被证明的s分开供营商节目： 具有资格的买家赢得1%在零件购买。 为更多这里点击。 
• vente $
• au sujet de
• My DOTmed 

This report originally appeared in the May 2009 issue of DOTmed Business News

For more than 30 years, traditional mammography has been the leader in breast imaging and has helped detect breast cancer in hundreds of thousands of patients, helping to save lives in many cases. While other modalities have come along to help detect better and clearer in some instances, mammograms are still the first choice of most doctors and breast imaging centers.

"The best population-based screening exam is still mammography because it works, is efficient, low cost, low dose and you can perform exams on a whole group of patients in a short amount of time," says Carl D'Orsi, Director of Breast Imaging Center at Emory and co-chair of the ACR Breast Imaging Commission. "It's the most tested technique of anything in the world and it is the gold standard to the nth degree and that will remain for a long, long time."




It was nine years ago when GE pioneered digital mammography with the introduction of the first full field digital mammography unit. Of course, the prices kept many away, as did the uncertainty of whether the digital was really that much better.

Digital taking over

The American College of Radiology Imaging Network (ACRIN) changed the way a lot of people thought. In 2005, they released the results of one of the largest breast cancer screening studies ever performed and it provides a strong starting off point for medical personnel when discussing the differences between film and digital mammograms.

The primary finding of the study was that for the entire population of women studied (49,528 women), digital and film mammography had very similar screening accuracy.

Where digital was deemed better was in women under 50, those with dense breasts, and those pre- or perimenopausal (defined as women who had a last menstrual period within 12 months of their mammograms).

"The study showed that the images were better with digital," says Stamatia Destounis, a doctor at Elizabeth Wende Breast Care, LLC. "The benefit is that we can manipulate the film. So after it is acquired, we can magnify an area, make it darker or lighter, bring something of interest to us in focus and look at it closely. Instead of having a technologist go back and ask for more X-rays, now we can manipulate the existing images and not necessarily have to take more images."

That helps to explain why a 2005 FDA report (before the ACRIN study) shows that only 8% of mammography sites were completely digital and only 6.3% of the remaining facilities carried at least one digital unit. At the end of 2008, 39% of all facilities were completely digital and 45% of all facilities in the US had at least one digital mammography unit.




"I think everyone recognizes that we will be totally digital at some point so we are now in the area where the large facilities have made the transition and it's the small facilities trying to justify the cost and looking for ways to become digital," says Pat Hall, Director Product Communication and Professional Relations for Hologic.. "The economic situation has made some hospitals become more cautious about expenditures so it may have slowed mammography to a small degree but not significantly."

When using digital mammography, optimal positioning and compression are critical in identifying a suspicious lesion. Unlike an analog image, which requires film to be developed, with digital mammograms, within seconds the technologist is looking at the image.

It is estimated that of the new systems being sold today, as many as 90% are digital. Physicians using digital mammograms find the relative quickness in obtaining results, as images are downloaded almost instantly, and ease of reading them, as they are able to zoom into or out of images and change the brightness or contrast, to be worth the extra expense.

"Many facilities see digital mammography as a way to maintain their competitiveness in their community," says Regina Radtke, Sr. Director Women's Health, Siemens Healthcare. "Proven advantages of digital mammography are highly visible to women seeking screening procedures, a fact that influences their choice of facility."

Recession Being Felt

The digital industry was very strong over the last few years as companies like GE, Hologic, Siemens and Lo-Rad took advantage of the digital advancements to achieve high-volume sales, but in the past 12 months, the industry has seen something of a slowdown.

"I think we projected that sales would decrease because of a saturation of the market and it was bound to level off," says Hall. "I think the economy has played its part too, but we tried to come up with different configurations that small users would be able to bring into their practice."

Other issues affecting the industry today are poor reimbursement, the economy and the inability to get financing.

"Many of the clinics that were planning to add digital mammography in 2009 are now reevaluating their budgets or putting off the purchase for four to six months until they see what the economy will do," says Becky Lowe, Modality Manager for Women's Health at Block Imaging International, Inc. "It's a very uncertain time for free standing centers and small independent or rural hospitals who can't afford to take a risk."

A digital system runs in the neighborhood of $350,000 vs. $70,000 for an analog system, so financial constraint does play a major role for many in the decision to make a switch.

For those who want to go digital but can't, they can try the next best thing by using Computed Radiography, which is an inexpensive alternative and provides some of the benefits of using a digital system.

"This allows facilities to continue to use their existing screen-film cassettes, but with an imaging plate that acts as a digital adapter," says Hall. "Computed radiology produces something that's similar to screen film but it produces a digital image. You would take a standard screen film gantry and use digital plates instead of cassettes and take them to a reader or processor and the image will be read out as a digital image."

The price point on these systems is cheaper than a full digital system and the PACS system required to go along with it, but it doesn't offer the same workflow efficiencies that are often wanted.




The economy may be causing problems on the patient side as well. There is a rising fear in the health care industry over a decrease in women getting a mammogram, which may be attributed to the economy and tightening personal budgets.

Many people are losing jobs and health care coverage, or switching to health coverage with higher deductibles where they can't afford to pay the co-pay, so they are skipping their yearly screening.

"Most recently, screening numbers have been declining, an alarming trend that requires immediate action," Radtke says.


Other modalities

While mammography is still considered the gold standard of breast imaging, as many as one in five cancers are still overlooked on the traditional mammography, creating a need for the use of other modalities to assist.

"A lot of women hear about all the different modalities, whether it be MR, CT, PET-and they come in and ask for an ultrasound or MRI instead of a mammogram," says Destounis, "but the most accessible screening test is the mammogram. It's easy, takes only a few minutes and is in every corner in any town or city."

New breast imaging technologies, such as breast MRI and automatic breast volume ultrasound, are entering the market and compete with/compliment digital mammography, thereby creating a complete Women's Health solution approach for patients.

"With digital images, we are now easily able to compare to other modalities, such as MRI and ultrasound; therefore the focus now changes from the mammography gantry to cross-modality capabilities and data management," says Radtke. "As new clinical applications enter the market, new digital mammography platforms are necessary to support future applications, such as tomosynthesis."

Change in Used Market

It was only a few years ago when used mammography equipment was almost exclusively analog since there was very little digital equipment coming into this market. And while many of the refurbishers and used dealers still have a lot of analog equipment to move, the demand is quickly turning.

"Domestically, digital mammography dominates the market even in small clinics and rural hospitals. This has been a huge change from where the market was three years ago," says Lowe. "Patients are seeking and choosing clinics that have digital technology . . . many of the sites we are working with are switching due to the demand from their patients."

David Denholtz, CEO of Integrity Medical Systems, Inc., says that 75% to 80% of the mammography equipment they sell now is digital.

"Many facilities that want to switch can't, as the economics are not there," he says. "Mammography is offered oftentimes as a loss-leader. Also, the liability of offering mammography as a service is the highest of any modality."

Metropolis International has seen 50% of its used mammography business switch to digital as customers gravitate towards the newer digital systems because of increased public awareness towards breast cancer and the ways to detect it.




"There are a lot of used analog systems on the market, a lot more than the market can handle and thus prices have dropped rapidly," says Leon Gugel, President of Metropolis International. "On the user side, reimbursements are low and doctors are incorporating mammography services with other imaging systems instead of having a stand alone woman's center, this way the cost of the digital unit is recovered faster and spread over more years."

John Pereira, CEO of United Medical Technologies Corp. adds that it's not always easy to find used digital mammography units to buy and refurbish, and when they do, they quickly are sold.

"I have never seen so many analog mammography units coming out because everyone in the U.S. is going digital," he says. "I don't know anyone who will buy a new analog machine, and if they are looking for a used one, it's almost always digital but there are very few out there. Everyone has jumped on the bandwagon."

Brian Van Almen, Account Manager for Classic Diagnostic Imaging, still sees a number of analog refurbishments and also a great demand for parts for these systems because of the market.

"With the economy the way it is, those big capital equipment things are being put on hold so people are trying to fix what they have and are looking for a more cost effective alternative," he says. "We have a 17,000-square-foot warehouse full of parts and offer a number of different refurbishment options."

Lowe says the way to stay competitive in an oversaturated market is by having systems in inventory and keeping them prepared to ship out for when orders come in.

"Typically when a customer decides to go digital, they want to start scanning as quickly as possible," she says. "We have an advantage by keeping several systems in stock in order to have a quick turn around for our customers."

Refurbished Process

Those who make a living refurbishing equipment have found that they needed to change with the times also, since new digital equipment was coming to their facilities. The process is a little different than the standard analog equipment.

At Metropolis, Gugel says they repair and service mammography units, which entails having the right engineering talent to know what needs to be done.

"Just like with all our refurbished systems, we first test the units to see what state they are in and see what is needed," Gugel says. "Then we take them apart, clean them, replace parts that are needed, replace belts and switches and test them to make sure they work. Once the tube is reloaded and the unit put back together, we put a coat of electro-static paint on the unit, calibrate and send it to be installed."

Integrity Medical Systems, Inc. trained their staff in digital from the outset and are fully prepared for any of the newer systems when it comes to refurbishments.

"All of the systems come here first and are fully calibrated," says Denholtz. "Digital systems are hooked up to our internal PACS and workstations are tested for functionality and calibrated image quality."

International Market

Classic Diagnostic Imaging is seeing a great deal of interest from the overseas market, especially when it comes to parts.

"Absolutely, it's a big emerging market," Van Almen says. "Brazil, South America, Japan also...the parts market is strong. I probably get three or four requests a week for quotes for overseas.."

Refurbished and used equipment are also selling well.

"Sales throughout Europe and Latin America are doing very well; though the economy has kept many of our clients from transitioning into digital. We are slowly starting to see the market shift but for many of our customers; the price of digital is still not an option," says Lowe. "We are starting to see changes in both Latin America and Europe as the prices of the early GE 2000D units become more affordable."

Looking Ahead

The biggest buzz in the mammography industry these days concerns the advent of 3D technology, called tomosynthesis, which is currently in testing trials and is awaiting approval by the FDA.

Digital tomosynthesis for mammography has shown promise to overcome the limitations of projection mammography. The main limitation of both film and digital mammography is the fact that the 3D anatomical information is projected into a 2D image plane. Therefore, anatomical structures that overlap the tumors limit the radiologist's ability to detect certain cancers. With breast tomosynthesis, several views of the breast are acquired from different viewing angles and slice images are reconstructed into a 3D volume set.

Hologic already is marketing their 3D product in Europe and getting a good response.

"The major benefit you get from 3D is you can look at a breast in multiple slices," says Hall. "You're looking at a 3D image of a 2D object by adding depth resolution. If you don't have a way to look through layers, you can miss a cancer. You can see tissue that looks suspicious but it's innocent. Tomosynthesis takes a series of exposures at different angles and a reconstruction algorithm is applied and you can look at 1 mm slices."

When it comes to 3D imaging on digital mammography, Radtke believes its usage will depend on reimbursement status, but suggests that Siemens' next digital mammography platform is being designed to evolve with future clinical applications, such as the 3D imaging.

"The focus is on providing our customers with a system that will protect their investment by being able to add new clinical applications to the system when they become available in the market without major downtime.," Radtke says. "Siemens continues to focus on support services, such as clinical connectivity support to ensure smooth integration into our customers' PACS networks, as well as hospital marketing needs to support efforts to reach out to our customers' community to market new technology and clinical procedures, such as digital mammography and biopsy services."

The goal of the OEMs is to create new diagnostic tools for screening to drive early diagnosis and offer lower-cost treatment options and improved patient outcome. For everyone involved in the health industry, anything that aids in earlier and better detection is the optimum outcome whether it's the latest technology or tried-and-true.

---

DOTmed Registered Mammography Equipment Sales & Service Companies
Names in boldface are Premium Listings.

Domestic
Joseph Shafe, Incite Imaging, AZ
DOTmed Certified
Jack Donovan, Broadwest Corporation, CO
DOTmed Certified
Christopher Cone, Echoserve, CO
David Denholtz, Integrity Medical Systems, Inc., FL
DOTmed Certified/100
John Pereira, United Medical Technologies Corp., FL
Jailyn Primus, X-Ray Service, FL
Dennis Giuzio, Mobile Radiology, Inc., FL
Robert Serros, Jr., Amber Diagnostics, FL
Lucien Jeanfreau, Diagnostic Equipment Sales, Inc., LA
DOTmed Certified
Davyn McGuire, Med Exchange International, Inc., MA
DOTmed Certified/100
Krista Kotrla, Block Imaging International, Inc., MI
Tony Orlando, Complete Medical Services, MI
DOTmed Certified/100
Ryan W. Gilday, Clinical Imaging Systems, Inc., NJ
Gary Benitez, Crown Medical International, NY
DOTmed Certified
Leon Gugel, Metropolis International, NY
DOTmed Certified/100
John Kollegger, Bay Shore Medical, LLC, NY
DOTmed 100
Jeff Weiss, Atlantis Worldwide, LLC, NY
Brian Van Almen, Classic Diagnostic Imaging, OH
DOTmed Certified
Jason Botko, A+ Medical Company, Inc., SC
DOTmed Certified/100
Patrick Doyle, Medical Exporters, Inc., TN
DOTmed Certified

International
David Lapenat, ANDA Medical, Inc., Canada
DOTmed Certified/100
Gautam Sehgal, ADS Diagnostic Limited, India
Artemio Santacruz, Ara Electric SRL, Paraguay

---