Universal Medical explores role of optical imaging in mammography

Digital enhancements boost technology's prospects

The development of optical imaging keeps on going and going andgoing… Someday, however, this aspiring diagnostic imaging modality—known over the years as transillumination or diaphanographyor just plain light imaging—may surprise the U.S. clinicalcommunity and gain acceptance as a low-cost yet safe and effectivecancer detection device.

Applying advanced digital image processing technology to theformerly analog modality could be the key to greater clinicalacceptance of optical imaging, first as an adjunct to mammographyin breast imaging, said Mike Baker, president of Universal MedicalSystems (UMSI) of Clearwater, FL. Substantially lower proceduralcosts than mammography might then give a boost in practice tothe technology, particularly with managed-care customers.

"We think that in the next five to 10 years, because ofadvances in optical imaging, this will be a generally acceptedand widely used medical technology," he said.

UMSI is initiating clinical testing in the U.S. of its prototypeoptical imaging system and hopes to file for 510(k) market clearancewith the Food and Drug Administration in the second half of thisyear, Baker told SCAN.

The company has an existing product line, including a CT simulatorfor use in radiotherapy planning, Baker said. It has been developingboth the optical imaging system and a spinal-injury managementsystem using motion sensors for the past three and a half years.UMSI went public in October 1995.

The UMSI optical imaging system uses digital capture and imageprocessing technology developed first in aerospace applications,he said. Digital optical imaging enables several types of imageenhancements not possible with analog systems and holds out thepossibility of tissue characterization for tumor detection.

"We are applying advances in optical imaging using near-infraredlight in a digitized modality," Baker said. "You cando so much once you have the digital capability and intricatesoftware (needed for such functions) as enhancement, segmentation,and magnification."

The system has special filters that eliminate the need fora darkroom in which to conduct the examination, he said. Thisis a major factor in keeping operating costs down. The deviceis also simple enough to use that an optical imaging procedurecan be performed in three to five minutes.

A single optical imaging breast imaging procedure may be performedat a cost of $10 to $15—a fraction of current mammography billings,which range from $80 to $150, Baker said.

Key to keeping costs down is that there is no need for x-rayfilms, processing equipment, or special shielding, he said. Theequipment purchase cost is also expected to be relatively low,under $100,000.

While optical imaging offers the cost advantages demanded bymanaged care, its benign nature—entailing no use of ionizingradiation—could in the future enable more frequent use forpreventive screening purposes, which is also encouraged by healthmaintenance organizations, Baker said.

UMSI is not positioning the optical imaging system as a replacementfor mammography, he said. That was one wrong move made by predecessorspromoting earlier transillumination technologies. The techniquecould, however, be used in cases when mammography is not advisablefor screening or between mammographic exams in order to screenmore frequently without the radiation risk. It also might be usefulas a safe method of monitoring patients following surgery.

UMSI plans to explore additional applications of optical imaging,first in prostate cancer imaging and then testicular and ovariancancer applications, Baker said. The company is also exploringuse of its image processing technology in ultrasound applications.

While clinical testing of the optical imaging system is underway in the U.S., UMSI plans to move forward rapidly in Asian andother world markets, he said. The firm already has two productionfacilities in China as well as a Korean joint venture, which willfocus on product marketing throughout the Pacific Rim, and eventuallymanufacturing.

China offers the greatest potential, not only because of itspopulation size but because optical imaging has been an acceptedtechnology there for breast cancer screening over the past decade,Baker said.

"The market is unlimited," he said. "(In China)it is not adjunctive but an effective screening procedure."

UMSI is also targeting Europe through a dealer network. Twodealers are already on board, and the firm is negotiating withfour others to handle all UMSI products in Western and EasternEurope, Baker said.