Health Canada Gives ART Authorization for SoftScan Trials

Advanced Research Technologies (ART) has obtained authorization from Health Canada's Therapeutic Products Directorate to begin its pivotal clinical study in Canada for its SoftScan optical breast imaging system.

This investigational testing authorization from Health Canada allows ART to initiate patient enrollment at two clinical sites in Canada. ART is expected to receive authorization for additional sites in the coming months.

The requirements for a Class III medical device, such as SoftScan, are highly demanding. The Health Canada authorization signifies approval of the protocol for pivotal studies in Canada and is part of the ongoing regulatory process prior to commercialization and the filing of a premarket approval application with the FDA.