Guided Therapeutics Inc.
Technology company Guided Therapeutics Inc. of Norcross, Ga., has completed an audit of its quality system to maintain ISO 13485 certification. This step is required to secure CE Marking for the sale of the company’s LuViva advanced cervical scan device in the European Union. Designed to provide instant results, the noninvasive diagnostic tool scans the cervix with light and uses spectroscopy for the early detection of disease. “Successfully completing these rigorous yearly audits shows that our processes and quality system are of the highest order,” said CEO Mark L. Faupel. The company submitted the CE Marking application in January; a 90-day review process was expected.