Guided Therapeutics has completed one of two major third-party electromagnetic compatibility testings of its non-invasive cervical scan device.
Using the company’s patented biophotonic technology, LuViva advanced cervical scan detects changes at the cellular level and identifies cancer and pre-cancer painlessly.
The third-party testing is being performed to label the LuViva scan with the ISO 60601 Edition 3 CE mark and Canadian Standards Association (CSA) mark.
Guided Therapeutics engineering senior vice president Richard Fowler said, "Basic safety testing, the next phase of work to be done at the third-party testing facility, is expected to be completed in the next two to three weeks.
Upon completion of the basic safety testing, LuViva will be eligible for labeling with the CSA mark, which is preferred by some larger medical institutions.
The company said the final step for the CE mark, after completion of the next phase testing, is to complete the review of documentation for usability, risk management and software, which is scheduled to occur over the next few weeks.
On completion of the review, the company will apply the Edition 3 CE mark to the LuViva to support international product launch in the first quarter of 2013.