Clinical testing of laser mammo system moves forward

Clinical testing of SoftScan, a laser-based mammography system developed by Montreal-based Advanced Research and Technology, is underway. A controlled pilot study designed to assess the system’s ability to analyze the optical signs of benign or malignant lesions in several applications has been initiated, and will be completed on time by September, according to ART.

ART believes SoftScan will offer a number of clinical benefits, including the elimination of nonionizing radiation. It can also be used without breast compression, and the vendor believes that SoftScan will be able to detect breast anomalies not previously visible.

ART is developing SoftScan with several partners, including Massachusetts General Hospital in Boston and optical research organization National Optics Institute. GE Medical Systems is assisting in the development process by participating in the pilot study. The Waukesha, WI-based vendor will also advise ART on clinical trial procedures in the U.S. and Canada, according to ART.

The final test phase for SoftScan will begin this fall, with clinical trials in Canada and the U.S. ART will apply for marketing clearance simultaneously in Canada, the U.S., and Europe. ART hopes to achieve marketing clearance in the three markets in late 2001, with commercialization set for early 2002.

By AuntMinnie.com staff writers
July 7, 2000

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