R2 sticks to high road in marketing CAD device

Allegations that R2 Technologies has sold its ImageChecker device to lawyers, ostensibly for use in malpractice suits, are false, according to R2. The company does not market its computer-assisted diagnosis (CAD) equipment to anyone other than radiologists and mammographers, said Michael Klein, president and CEO.

“There’s a very good reason for that: The clinical claims we make about the product are based on its use by trained radiologists,” Klein said. “The same results won’t be achieved if it is used otherwise.”

The possibility that CAD technology might be used against radiologists-an allegation promulgated on the Internet and picked up by a DI SCAN source-raises the issue of unintended consequences of new technology introductions. And there is reason for concern that this type of technology might be so used.

Visibility afforded by the lay press and television programs, including “The Early Show” (with Bryant Gumbel), have piqued interest among a wide variety of consumers and some attorneys, said Laurie Hallwyler, director of corporate communications for R2.

“We have received inquiries for information about the device from attorney firms that are interested in how it works,” she said. “But we have made no sales.”

There is little question, however, that the device could prove useful as a “risk management” tool, said Dr. Richard Anderson, chair of the board of governors of The Doctors’ Company, a national medical malpractice insurance carrier.

“The promise of reducing the incidence of the most common malpractice suit in the U.S. is added incentive for widespread evaluation of this system,” Anderson said in an editorial in the June 8 issue of The Doctor’s Advocate, the organization’s member newsletter.

Despite such endorsements, R2 has taken the high road in marketing the product, avoiding reference in its marketing materials to any risk management advantage the ImageChecker might offer. That is intentional, Klein said.

“We go out of our way not to force the issue of defensive medicine,” he said. “We think that the merits of the technology and the clinical findings stand on their own. It’s not necessary to add fear to the equation.”

The company remains dedicated to promoting the use of CAD for its intended purpose, according to Klein-to reduce the number of missed or delayed diagnoses of breast cancer. These represent an area of high liability for radiologists, with judgments averaging $300,000 (SCAN 5/23/01).

Although mammography remains the gold standard for breast cancer detection, it is plagued by nonspecific findings. Its cancer detection sensitivity averages 80%, which means that one in five cancers on a mammogram go undetected. The reasons range from lack of visibility to incorrect interpretation by radiologists.

CAD tools like the ImageChecker could improve those stats. The device uses neural network technology to analyze digitized mammograms for potentially cancerous structures. Published studies indicate that the system may provide early detection of up to 20,500 additional breast cancers per 100,000 cancers detected by screening mammography.

Such a clinical advance-and the fact that the service is reimbursable by Medicare and some private payers-has been incentive enough to spur adoption of the device, with about 200 installed in 150 sites across the U.S. An estimated 1.25 million women have had their mammograms reviewed using the device.