Canadian firm joins race to develop optical-based mammography system

ART's Softscan enters final development phase

If Canadian high-tech firm Aerospace Research Technologies (ART) has its way, Imaging Diagnostic Systems (IDSI) of Plantation, FL, will soon have company in the development of laser mammography breast imaging systems. ART of Montreal announced last week that it has entered the final development phase of Softscan, a noninvasive mammography imaging method based on laser technology.

Softscan employs an optical imaging technique similar in concept to IDSI's Computed Tomography Laser Mammography (CTLM) system, in which a laser light source is trained on one side of the breast, while a detector on the other side is used to pick up light as it is transmitted through tissue. The wavelength of the laser does not affect breast tissue.

A key difference between Softscan and CTLM, however, is that Softscan uses a stationary light source to create 2-D images, whereas CTLM's lasers rotate around the breast to create 3-D tomographic images. Both systems use near-infrared laser wavelengths. Among the benefits of Softscan is that it requires less compression than x-ray systems, according to Pierre Beaudry, ART's director of research and development of medical devices.

"We've proven experimentally that our best images are acquired with medium compression, which basically translates to stabilizing the breast," Beaudry said.

Proponents of mammographic optical imaging, known sometimes as transillumination, cite its safety: Since it does not use x-rays, the patient is not exposed to radiation. Such systems are radically different from the x-ray-based mammography technology on the market, however, and optical mammography developers have a long road ahead in familiarizing the breast imaging community with the technology.

ART plans to move Softscan to clinical trials by November in an effort to introduce the system to the Canadian market in 12 to 18 months, said Lisette Therrien, ART spokesperson. Softscan could be presented to the U.S. market by 2000, depending on how quickly it moves through the Food and Drug Administration's regulatory process, Therrien said. Like other optical imaging systems, Softscan will be regulated by the more stringent pre-market approval (PMA) process rather than the 510(k) track that most imaging devices follow. IDSI's CTLM system is in the first phase of human clinical trials; it must complete another round of trials before the firm can submit its PMA.

ART is owned by private shareholders and the Caisse de Depot et Placement du Quebec, a government-owned institution that provides venture capital. The company has a market capitalization of $75 million (Canadian). In addition to the work-in-progress Softscan, ART markets ISIS, a system that analyzes the quality of printed circuit boards.