"Of course Hologic has done some selling of its own. The firm which markets itself as The Womens Health Company makes other products including a D digital mammography machine a test that assesses risk of preterm labor gynecological products including Adiana a permanent contraception technique and widely used equipment that measures bone density. But D mammography could become its flagship because for the moment it owns the entire market  although other companies including powerhouse GE are developing their own D machines Hologic is the only one with FDA approval thus far. Of course given the sluggish economy and the continuing state of uncertainty around American health care persuading hospitals to upgrade may be challenging. So perhaps its not surprising that the companys PowerPoint presentation to the FDA included the unsubtle phrase huge breakthrough or that the first American patient to undergo D mammography  Laura Lang a polished yearold Boston marketing executive and breast cancer survivor  did so in front of a CBS camera crew last February.    Indeed they do. Theyre catching on like  well its not a slow burn. The device earned Food and Drug Administration approval on February  and for a short time it was available only at MGH. Now it is available in at least nine states three of which have multiple sites and most of the several dozen hospitals around the United States that assisted with clinical trials are planning to buy systems too. The images arent the only selling point. The early data are compelling as well. In studies presented to the FDA radiologists reported a  percent improvement in their ability to distinguish cancerous from noncancerous cases when they used the new system. If that sounds unimpressive consider that  million women are screened each year any significant reduction in callbacks for additional testing would mean hundreds of thousands of women would be spared painful and expensive followup.    Dr. Elizabeth Rafferty is trying not to lapse into rhapsodic cliches. I dont want to call it a magic bullet because that would oversell she says. Its not a panacea. Then five minutes later I dont want to say its catching on like wildfire. After a few minutes more though Rafferty cant help herself. She lets her enthusiasm loose. People have been waiting for it for a long time she says. Its a step but its a step by a person who has a stride of  feet. It is a D mammography machine the Selenia Dimensions system one of which sits in the breast imaging clinic at Massachusetts General Hospital that Rafferty a radiologist runs. The machine which is made by the Bedford company Hologic and developed partly at MGH under Raffertys supervision produces images that are so vivid and clear they seem to speak out loud Hey right here This is a tumor If you look at enough of them you may become convinced that you dont need medical training to spot a case of breast cancer or distinguish a false positive on a mammogram from a true one. The distinction seems that clear. If you can tell the difference as a nonradiologist imagine how a radiologist feels says Rafferty. The images sort of sell themselves.    Much of the criticism focused on the data the task force had used to make its decision which consisted largely of the results from prospective randomized clinical trials conducted in the United States. Trials like this are the gold standard of medical evidence. They are also expensive and timeconsuming and thus hard to come by. The most recent such trial looking at mammography and mortality in the United States was published in the s. A lot of the people on the task force are my friends and I have tremendous respect for them but this was a big point where we differed says Brawley. The standard type of mammography thats used all over the country today may very well be better than what was used in that trial. So the outcomes may be better too. The studies the task force had chosen to examine showed that screening beginning at age  had little impact on mortality while at the same time generating a significant number of false positives. Those data were complete and comprehensive. But says Brawley they were outdated.    The task force wasnt expecting a firestorm. That however was what it got. Breast cancer advocacy groups mutinied saying the guidelines would cause significant numbers of women to go undiagnosed for years some of them fatally. Politicians started giving scary speeches about rationing health care. Many radiologists  including the MGH department as a whole  rejected the new guidelines. Daniel Kopans a world leader in breast imaging he wrote the textbook of that name and a radiologist at MGH now says that the panel didnt understand mammography screening. Furthermore he adds the new guidelines had no biological or scientific reason behind them.    The last time someone tried to improve the way American women are screened for breast cancer it turned into a national debacle. In November  the US Preventive Services Task Force a governmentbacked group of doctors charged with making recommendations that often influence what insurers will pay for updated its guidelines for mammography. Previously it had advised women to begin annual or biannual screening at . The new guidelines pushed that age to  emphasizing that starting earlier should be an individual choice.    Debates about mammography are often so emotionally charged that this type of nuance goes missing. I think some of our rhetoric  medicines in general and also that of advocates has made people think that every metastatic breast cancer is a failure of the woman to get a mammogram or of a doctor to read a mammogram correctly says Otis Brawley chief medical officer of the American Cancer Society and a professor at Emory Universitys School of Medicine in Atlanta. In reality yes mammography does save lives  but it is far from perfect. Its not as good as many people think it is. So if the new D mammography isnt perfect just how good is it    But the company and the rest of us should be careful not to overhype D mammography. As Rafferty says its not a panacea. The technology does come with costs financial and medical. A fully equipped D machine runs on average  not including the annual service fee Hologic charges for maintenance and even hospitals that already own an upgradeable D system made by Hologic have to pay about  to get it adapted for D use. There are also costs in the sense of risks Women who get a combo D and D mammogram the protocol that confers the most dramatic jump in benefits are exposed to twice as much Xray radiation as the norm albeit still an amount thats under the FDAs permitted limit. And no one yet knows if the new technique will actually save lives.    Is Hologics D mammography machine likely to fare better There are reasons to think it will. Unlike MRI which requires an injection with contrast dye and an hour in the imaging machine it isnt an ordeal  or at least its no worse than a conventional mammogram. Yes you still have to endure the dreaded clamp. And it seems to be more effective than its most similar precursor the D digital technique. Early data from Raffertys trial showed that the same group of women who did benefit from D digital benefited even more dramatically from D. Its worth noting that this is not a small group of people. Fifty percent of women are in what the American Cancer Society considers the intermediate zone of risk which overlaps considerably with the group that saw some benefit in DMIST. Perhaps more important even the women who didnt see any improvement in accuracy with D get a small boost with D over film. And D seems to be both more sensitive and more specific  improvement in one area doesnt have to come at the cost of the other.    But when the definitive trial of D digital techniques called DMIST was published in  tracking nearly  patients it didnt provide the answers that advocates had been expecting. Digital mammography did seem to perform more accurately than film in women who were younger than  women who were pre or perimenopausal and women with dense breast tissue. But when all women were considered as a group that benefit disappeared. On the whole it turned out digital just didnt live up to the way it had been sold.    When D digital mammography was introduced in  doctors hoped it would vault over those problems. Well most of them. The cost concern was still present Digital mammography machines were five times as expensive as film ones. The marketing materials suggested it already had. An ad for GEs D digital system that ran during the Summer Olympics called it a major new breakthrough in the fight against breast cancer. Digital technology the thinking went would show nuances that film never could because it could render literally many more shades of gray.    The problem however was that each time they introduced a new imaging tool for breast cancer they found that they could not advance on one front without taking a step backward on the other. First there was ultrasound says Rafferty. We did find more cancers but we also found so many false positives that it was untenable. Then there was MRI which had the same problem  and it was  times more expensive than mammography.    Rafferty had already been running trials of D mammography for two years when the task forces guidelines came out. She understood its concern about false positives  she was trying to address it herself albeit in a very different way. In fact technology developers had been trying in various ways for years to increase mammographys sensitivity its ability to flag possible cases of cancer while also increasing its specificity its ability to filter out the false positives.    Theres an intuitive argument for why D mammography might be more accurate. The technique works a little like a CT scan does it takes  pictures of the breast at slightly different angles then fuses them into a single synthesized image. If breast cancers were spherical in shape theyd look basically the same in all  images or for that matter on a conventional D picture. But theyre very rarely shaped that way in reality. In the breast in particular cancer cells tend to creep out singlefile along the architecture of the body says Rafferty. And that makes some of them especially hard to see on a D mammogram. They look like distortions not blobs. Theres another thing about cancer that is much clearer on a D mammogram spicules or thin spidery tentacles emerging from the center of a tumor. D images when taken from the wrong angle are often too fuzzy to show them. In D however the spicules are visible in high resolution  and seeing them is critical since they are a hallmark of malignancy.    To Rafferty the existing data are persuasive enough. I own no stock in Hologic. I have no financial ties to them. And I was skeptical of this idea at first. You think to yourself it is that simple That elegant she says. But this really does address the fundamental flaw of mammography. I want every woman to have access to this technology. I got my sisters down here when it was approved. I was like Youre all going to get this Because in my heart I know its better.    Andy Smith Hologics vice president of imaging science is similarly hopeful. Its expected to improve the cancer detection rate. It is going to reduce the recall rate he says referring to suspicious findings that require women to return for followup tests some of which turn out to be false alarms. And we will have more numbers on that within one to two years. This last part at least is very likely true. Mammography is heavily regulated and clinics are required to send their recall statistics  the number of women they call back for second looks  to the federal government. The data on whether D will save more lives than D may not be known immediately. But they will exist.    However the most meaningful data  the numbers that would show whether D mammography saves womens lives  wont be available for decades. Only a prospective randomized trial with mortality as its endpoint can say for sure and thats how long it takes to conduct one. Smith knows that thats the reality. We are expecting a reduction in morbidity and mortality but we wont know that for a long time he says. You know this technology has only been approved for two months.    By the time such data do come out mammography will surely have changed again. There are already efforts to augment it with contrast dyes to develop a complementary tool called a gamma camera and to augment imperfect human judgment by refining computer programs that can spot tumors as well as a radiologist might.    What this means is that the next time the US Preventive Services Task Force or anyone else wants to take a hard look at mammography the data it has will once again be outdated. Its inevitable. ThreeD mammography may very well be more accurate than D. It may see more cancers and fewer impostors. But whether its truly a huge breakthrough by the metric that matters most is a question that cant currently be answered  and that may be irrelevant by the time it can be. Rafferty may know in her heart that D is better. But right now at least thats the only way she truly can."