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ART files Canadian license application for SoftScan breast imaging device
By Elaine Rigoli
Tampa, Fla., June 22 - ART Advanced Research Technologies, Inc. said it has filed a Medical Device Licence Application with Health Canada to begin the commercialization of its SoftScan breast-imaging device.
The granting of a license will allow ART to distribute the SoftScan device in Canada by certifying that the device is safe and effective and meets quality standards.
ART said it is seeking regulatory approval of SoftScan as an adjunct to X-ray mammography.
The system uses a non-invasive, pain-free approach based on time-domain optical imaging technology that enables the characterization of breast tumors by clinicians as benign or malignant, without exposing the patients to potentially harmful radiation.
ART is a medical-device company located in Saint-Laurent, Quebec.
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