ART (Advanced Research Technologies) enters SoftScan into North American pivotal trials
This article was originally published in Clinica
Canadian imaging firm Advanced Research Technologies (ART) has moved its breast cancer detection technology, SoftScan, into North American pivotal trials. The company intends to use results of the study, taking place at the McGill University Health Center in Montreal, Canada, in support of marketing applications to the US FDA, under a premarket approval (PMA) application, and Health Canada. The study, which is expected to run through into 2006, will examine the clinical safety and effectiveness of SoftScan in 600-950 women aged 25-60. SoftScan is a noninvasive, nonionising optical imaging technology used in adjunct to mammography to help doctors diagnose and manage breast cancer. It uses near infrared light to help differentiate between benign and malignant structures, thus preventing patients from having to undergo unnecessary and unpleasant biopsies, the Montreal firm said.