It says multinational suppliers, not Chinese companies, will reap most of that bonanza.

In a news release promoting a new report about the Chinese market, InMedica says shipments of analog X-ray equipment to China will decline at a compound annual growth rate of 14.2 percent over the next five years while the overall Chinese X-ray market increases at a compound annual growth rate of 9.5 percent.

According to the release, the Chinese government, as part of a health-care reform announced in 2009, bought a lot of analog equipment for rural clinics. Many of those clinics are now trying to upgrade to digital.

China’s larger hospitals, in both rural and urban areas, are also going digital. The release says level 3 and large level 2 hospitals are looking to digital X-ray equipment to increase revenue. Once a hospital reaches its effective capacity of 100 daily patient scans per digital radiography (DR) system, it’s ready to buy an additional system.

The release quotes Owen Tang, a Shanghai-based analyst for InMedica, as saying that “almost all new systems purchased by these hospitals will be high-specification flat panel detector-based DR X-ray.” He added:

Unlike other kinds of X-ray equipment, such as mammography and fluoroscopy X-ray, DR equipment can help hospitals increase their revenue stream based on their more frequent use. In fact, return on investment is a critical factor for hospitals making a purchase decision, as current investment from the government is not enough.

Most of this new equipment will come from multinational companies, the release says: “Most level 3 hospitals and big level 2 hospitals [are] only willing to purchase the equipment from nondomestic suppliers.” Chinese manufacturers are concentrating their marketing on county-level hospitals.

No wonder GE Healthcare last year moved the global headquarters of its X-ray business to Beijing.

Related seminar: The Business of Radiology

In Keillor’s fictional Lake Wobegon, all the women are strong, all the men are good-looking, and all the children are above average. At the much less bucolic FDA, some scientists and doctors are fighting with administrators over approval of radiological devices, and the administrators are fighting back by monitoring the staffers’ personal e-mail.

Meanwhile, the FDA announced a tentative deal with medical device makers that would double its user fees in exchange for a faster and more transparent device-review process.

So, kind of a roller-coaster week.

Last week began with the news that six former and current FDA staffers, including two doctors and an MD/PhD, had filed a lawsuit alleging that the agency had spied on their nonwork e-mail, which the staffers had accessed through work computers. The suit also charges that the FDA fired or otherwise retaliated against them for leaking documents to Congress and the press.

Science magazine has a good summary of the situation, including a link to the lawsuit. What’s most significant for the medical community and the public is the viciousness of the infighting as FDA managers push for approval of radiological devices against the advice of their own medical and scientific experts.

The Washington Post points out:

Most of the devices the scientists and doctors questioned have received approvals only in the past two years, making it difficult to evaluate whether the fears that the FDA scientists and doctors expressed were valid.

Against that backdrop, the FDA announced on Wednesday the user-fee agreement, which is intended to speed up that very same approval process for medical devices. DOTmed News quoted Stephen Ubl, president of the Advanced Medical Technology Association trade group, as saying:

We believe this agreement is a potential game changer for the FDA, for industry, and, most importantly, for patients and the American economy.

The FDA said the agency would collect $595 million, plus adjustments for inflation, in user fees over five years, allowing it to hire more than 200 full-time-equivalent workers. “The FDA and the industry expect that the agreement in principle would result in a reduction in average total review times,” said the agency’s announcement.

Great. But the FDA has to do a better job in balancing the legitimate economic and political pressure to get useful devices approved with its duty to make sure that the devices are indeed useful as well as safe.

The Washington Post story quotes one of the lawsuit plaintiffs as saying a team of FDA experts three times recommended against approving a computer-aided imaging device for detecting breast cancer. Each time, the plaintiff said, middle managers agreed. Then, after the third rejection, a senior manager approved the device.

Something’s wrong, and adding more money and more staff won’t fix it.

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Meanwhile, the device industry still hates an upcoming excise tax; see our Facebook page.

Related seminar: Radiology Review Course

Michael Bailey, PhD, one of the project leaders, summed up the research this way:

We have a diagnostic ultrasound machine that has enhanced capability to image kidney stones in the body. We also have a capability that uses ultrasound waves coming right through the skin to push small stones or pieces of stones toward the exit of the kidney so they will naturally pass, avoiding surgery.

Dr. Bailey is a co-investigator with the Smart Medical Systems and Technology Team at the National Space Biomedical Research Institute (NSBRI) in Houston. He is also a researcher at the Applied Physics Laboratory at the University of Washington (APL-UW) in Seattle. He was quoted in an NSBRI news release.

Astronauts are particularly susceptible to kidney stones because it’s difficult to keep them hydrated. Also, bones demineralize in reduced gravity, leading to elevated levels of salt in urine, which is a kidney stone risk factor.

Dr. Bailey and Lawrence Crum, PhD, principal investigator for the Smart Medical Systems and Technology Team and also an APL-UW researcher, have tinkered with an ultrasound machine to create a combined B-mode and Doppler mode. In Doppler mode, for reasons that are not yet understood, a kidney stone can appear brightly colored and twinkling. So, said Dr. Bailey:

We present the stone in a way that looks like it is twinkling in an image in which the anatomy is black and white, with one brightly colored stone or multiple colored stones.

The stone can then be targeted with a focused ultrasound wave to push it toward the ureter. The stone moves about a centimeter per second.

This technology obviously can be used on the ground as well. Dr. Bailey said the focused wave could clean up stone fragments that typically remain after kidney stone surgery.

“Space has demanded medical care technology that is versatile, low-cost, and has restricted size,” said Dr. Crum. “All of these required specifications for use in a space environment are now almost demanded by the general public.”

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A radiologic technologist asks a friend to be a guinea pig for a test of new MRI software. The test saves the friend’s life. Read about it on our Facebook page.

Related seminar: Imaging Advances: Abdominal, Thoracic, Skeletal

So says a study by researchers at Henry Ford Hospital in Detroit. They presented it this week at The Triological Society’s annual Combined Sections Meeting in Miami Beach, Florida.

The study retrospectively reviewed the cases of 1,681 patients with dizziness or vertigo who visited a Detroit metropolitan emergency department during the period of January 2008 through January 2011. Of those, 810 received a CT scan of the brain and head, at a total cost over the three years of $988,200. Only 0.74 percent of the scans found anything that required intervention, such as intracranial bleeding or stroke.

Study author Syed F. Ahsan, MD, said:

It is our hope that our investigation into our own practices will shed light on avenues to run leaner practices within our institution, as well as serve as a model for other health systems.

Dr. Ahsan is a neuro-otologist at Henry Ford Hospital, so it seems obvious which “Detroit metropolitan emergency department” the researchers might have studied. He was quoted in a hospital news release.

The problem with CT use in those circumstances is that while intracranial bleeding or stroke may cause dizziness, lots of other causes are more likely. The news release cites dehydration, anemia, drop in blood pressure when standing (orthostatic hypotension), inner-ear problems, and vestibular neuritis.

Dr. Ahsan also noted that previous studies have shown that CT scans don’t do a very good job of detecting stroke or intracranial bleeding in an emergency department setting anyway.

“When a patient comes into the emergency department experiencing dizziness,” he said, “a physician’s first line of defense is often to order a CT scan to rule out more serious medical conditions. But in our experience it is extremely rare that brain and head imaging yields significant results.”

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Two Florida bills would force imaging clinics and other medical offices to post their prices; see our Facebook post.

Related seminar: Emergency Radiology

Terahertz waves, also known by the much cooler-sounding name “T-rays,” are in the far-infrared part of the spectrum—some say between the microwave and infrared zones. Their wavelengths are hundreds of times longer than those of the rays in the visible light spectrum. Their most common use right now is in airport security scanners.

T-rays have great potential for medical imaging applications. They don’t penetrate deeply into the body. But each type of molecule has its own unique signature in the T-ray range. So T-rays can distinguish between, for example, normal cells and cancerous cells. They can also detect such phenomena as increased blood flow around tumors.

Researchers have just announced a breakthrough that focuses T-rays into a much stronger directional beam than had been possible, and at room temperature. For details, see a study published online this month in Nature Photonics. Previously, T-ray generators had to operate at very low temperatures, which is expensive.

Stefan Maier, PhD, a coauthor of the study, sees vast potential:

T-rays promise to revolutionize medical scanning to make it faster and more convenient, potentially relieving patients from the inconvenience of complicated diagnostic procedures and the stress of waiting for accurate results.

The idea is to use T-rays in a portable sensing, computing, and data communications device, like the tricorder of Star Trek fame. Dr. Maier was quoted in a news release from Imperial College London, where he is a physics professor.

T-rays’ possibilities intrigue others as well. Rensselaer Polytechnic Institute of Troy, New York, has created a Center for Terahertz Research that encompasses four separate laboratories. According to its Web site:

Perhaps the greatest potential for this research lies in biomedical imaging and genetic diagnostics. T-rays offer hope for improved detection of breast cancer through sharper imaging and molecular fingerprinting.

However, there may be a complication. T-rays are not ionizing, and they don’t break chemical bonds. But some studies have reported genetic damage, possibly through interference with DNA. Other studies have found no such effects.

We’ll definitely be hearing more about T-rays. Stay tuned.

Related seminar: Radiology Review

“Currently no standard approach to the evaluation of peripheral neuropathy exists,” said Brian Callaghan, MD, assistant professor of neurology at the University of Michigan Medical School. “We need more research to determine an optimal approach. We do a lot of tests that cost a lot of money, and there’s no agreement on what we’re doing.”

Dr. Callaghan led the research. He was quoted in a University of Michigan Health System news release.

The study was published Monday in Archives of Internal Medicine. It examined the use of 15 “relevant” tests in diagnosing the disorder. The closest thing to a standard approach right now is an MRI of the brain or spine, which was used for 23.2 percent of the patients studied.

Unfortunately, the researchers think that’s a bad idea. They’d prefer a glucose tolerance test, which was used for only 1 percent of the patients. Here’s how the study puts it:

Almost one-quarter of patients receiving neuropathy diagnoses undergo high-cost, low-yield magnetic resonance imaging, whereas few receive low-cost, high-yield glucose tolerance tests.

The most common cause of the nerve dysfunction that characterizes peripheral neuropathy is diabetes. Hence the efficacy of a glucose tolerance test.

Of course, there can be a lot of other causes too, some of which MRI does detect well. However, expect health care’s cost-cutting forces to target its use, at least as a first option. As Dr. Callaghan put it: “Our findings, that MRIs were frequently ordered by physicians but a lower-cost glucose tolerance test was rarely ordered, show that there is substantial opportunity to improve efficiency in the evaluation of peripheral neuropathy.”

Related seminar: Diagnostic Imaging Review: For Residents, Fellows and Radiologists

So why, ask two experts at The Johns Hopkins Hospital in Baltimore, should we think that the imaging-based virtual autopsy, or “virtopsy,” is ready to replace the traditional direct physical inspection of the body’s internal organs?

Pathologist Elizabeth Burton, MD, deputy director of the autopsy service at Johns Hopkins, said that despite the dazzling postmortem scans depicted on such TV series as Bones and the various CSI shows:

The traditional autopsy, though less and less frequently performed, is still the gold standard for determining why and how people really died.

Dr. Burton was quoted in a Johns Hopkins news release. She and Johns Hopkins clinical fellow Mahmud Mossa-Basha, MD, state their case in an editorial in today’s edition of Annals of Internal Medicine.

A German study in the same issue shows some of virtopsy’s strengths and limitations. Among 47 people who underwent both virtual and conventional autopsies, 102 new diagnoses were found. Virtual autopsy by CT scan missed 20.8 percent of the new diagnoses, particularly air pockets in collapsed lungs (which can impede breathing) and bone fractures. Conventional autopsy missed 13.4 percent, most commonly heart attack, pulmonary emboli, and cancer.

That suggests that the best approach would be a combination of traditional autopsy with scanning. Dr. Burton agreed. “It’s not a question of either traditional autopsy or virtopsy,” she said. “It’s a question of what methods work best in determining cause of death.”

For example, she said, imaging can pick up a spot on a lung. But it can’t tell whether that spot is cancer, a fungal infection, tuberculosis-related granuloma, or a benign mass. For that, you need a physical examination.

On the other hand, a conventional autopsy without scanning might have missed that spot altogether. “Steady progress in imaging technology is refining conventional autopsy,” said Dr. Mossa-Basha, “making it better and more accurate.”

Related seminar: Imaging Advances: Abdominal, Thoracic, Skeletal

The Columbia Daily Tribune newspaper of Columbia, Missouri (home of the university), reported Sunday that:

Multiple sources have told the Tribune that radiology employees, including low-level staff members, recently were instructed by the UM System General Counsel’s office not to delete e-mails or destroy documents, indicating an investigation.

The newspaper also reported that an internal audit published in late 2010 found that University of Missouri Health Care had been providing radiology services to Medicare patients at Women’s and Children’s Hospital in Columbia without proper physician orders. The audit found that 62.5 percent of the cases it reviewed lacked proper authorization.

University of Missouri System attorney Paul McGuffey told the paper, “The fact that physician signatures didn’t accompany orders didn’t necessarily mean services were unnecessary.”

The newspaper reported that a new computerized order entry system seems to have cleared up the problem.

It’s unclear whether the radiology department investigation is related. In fact, it’s not certain that there is an investigation. Neither the university nor officials at the U.S. Department of Justice and the Missouri Department of Health and Human Services would confirm or deny the existence of one—although, as the newspaper suggested, the document-preservation instruction is a pretty strong clue.

Here’s another: the quiet departure late last year of Kenneth Rall, MD, as radiology department chairman. “The announcement of his retirement,” the newspaper reported, “came in a three-sentence blurb tucked between news of a Xerox partnership and a weekly quiz in the Dec. 21 issue of MU Health Care’s ‘InSight’ newsletter.”

Dr. Rall remains a faculty member. Amolak Singh, MD, is interim chairman.

Dr. Rall’s past includes accusations of embezzling money from his radiology partners in the 1980s, the Tribune reported. He faced felony charges of writing checks for bogus Medicaid refunds and then signing the checks over to himself. A few days before the trial, the prosecutor overseeing the case said he had lost the evidence. Dr. Rall wound up with a misdemeanor stealing conviction.

He also testified that he had paid back $928,000 that he had gained from a check-kiting scheme in which he used the “float”—the time lag in communication between banks in those pre–electronic banking days—to inflate one account balance with nonexistent funds from another account.

We’ll keep an eye out for developments.

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On this Martin Luther King Jr. Day holiday in the United States, many health care workers are nevertheless on the job, serving patients, so we’re not taking the day off either. See our latest Facebook post here, and follow us on Twitter here.

Related seminar: National Diagnostic Imaging Symposium

Back in November, a patient at the Drumheller Health Centre in the town of Drumheller, in central Alberta, complained about a sudden change in treatment after an X-ray. That led to a review of 249 CT scans, ultrasounds, and X-rays read in November and December by a radiologist at the hospital.

That radiologist made mistakes of “considerable concern” on 34 CT scans, according to Chris Eagle, MD, president and chief executive officer of Alberta Health Services, the province’s health-care provider in Canada’s national health system.

Think about that for a second: the radiologist misread almost 14 percent of the 249 CT scans, ultrasounds, and X-rays—and all of the misreads were of CT scans. The Toronto-based newspaper The Globe and Mail last week reported that:

The findings thus far are so alarming that officials have further expanded the review of the radiologist’s work to reassess about 1,300 CT scans performed over the past six months. That review will take several weeks.

“Alarming” is an appropriate word. Health officials said the radiologist was experienced and had worked at the hospital a long time, but they did not release his name nor where he was trained. They said he was asked to take a leave of absence. According to The Globe and Mail, “The individual is now vacationing abroad, and his professional future is up in the air pending the review, officials said.”

Meanwhile, the Alberta government has ordered a review of all diagnostic imaging and pathology testing in the province. In November, the Health Quality Council of Alberta, the province’s independent health-care watchdog, began reviewing whether 31 biopsy tissue samples were properly handled in Calgary after problems were found. And in December, the council was asked to examine 1,700 diagnoses made by a pathologist at a hospital in Edmonton. Dr. Eagle said at least 159 of those biopsies may have been misinterpreted.

Despite all that, the man who ordered the provincewide reviews, Alberta Health and Wellness Minister Fred Horne, told reporters:

I have no reason to believe that patient care is at risk.

OK, patients are panicking, and he pretty much had to say that. Much more sensibly, he also said: “This is not about blaming the people that deliver the care. This is about answering some very fundamental questions about checks and balances in our health-care system.”

Related seminar: Computed Body Tomography: The Cutting Edge

University of Pennsylvania engineers coated iron oxide nanoparticles with glycol chitosan, a sugar-based polymer that reacts to acids. The sugar keeps the particles from binding or being absorbed by the body, but this particular formulation allows them to become ionized in acidic environments and thus attracted to such areas.

Enter the Warburg effect: Most healthy cells are aerobic, getting energy primarily from oxygen, but cancer cells are anaerobic, getting energy from glucose and turning it into lactic acid. Cancer cells also disrupt the blood flow around them, making it harder for the body to clear away the acid.

So acid-attracted iron oxide nanoparticles will cluster around tumors and make them stand out on MRI images. Said Andrew Tsourkas, PhD, who did the research along with graduate student Samuel H. Crayton:

One of the reasons we like our approach is that it hits a lot of tumors; almost all tumors exhibit a change in the acidity of their microenvironment.

Dr. Tsourkas, an associate professor of bioengineering at Penn’s School of Engineering and Applied Science, was quoted in a Penn news release. The research was published in the December 27 issue of ACS Nano.

The new coating could work well for other uses too, Dr. Tsourkas said:

You can take any nanoparticle and put this coating on it, so it’s not limited to imaging by any means. You could also use it to deliver drugs to tumor sites.

It gets better: The more malignant a tumor, the more it disrupts blood vessels, and therefore the more aciditic its environment. So the new nanoparticles do a good job differentiating malignant from nonmalignant tumors.

That could particularly benefit patients getting an MRI scan as a secondary breast cancer screen. MRI’s high sensitivity but low specificity can work against it, as Dr. Tsourkas explained: “The screening detects a lot of tumors, but many of them are benign. Having a tool like ours would allow clinicians to better differentiate the benign and malignant tumors.”

That explains why the research was funded partly by the Department of Defense Breast Cancer Research Program (yes, such a thing exists).

Related seminar: CT/MRI of the Abdomen and Pelvis