Guided Therapeutics has obtained CE mark approval for its non-invasive LuViva advanced cervical scan.
The approval is based on a US multi-center, pivotal trial, which enrolled 1,607 women at risk for developing cervical disease, to detect cervical cancer.
LuViva detected 86.3% of the cervical disease, two years earlier than the Pap test, human papillomavirus test, colposcopy and biopsy.
Guided Therapeutics president and CEO Mark Faupel said the notification of CE mark for LuViva is a milestone for the company and allows it to begin European launch later in 2012.
"We believe that together with our distributors, we have a tremendous opportunity to improve the detection of cervical disease, reduce false positives and unnecessary biopsies, and provide significant savings to healthcare systems throughout Europe," Faupel added.
"We expect the CE Mark award will generate more demand for the product and open opportunities in markets outside the EU as well.
"In addition to the more than 20 countries already covered by distribution agreements, we plan to expand our network to additional countries in Europe, Latin America and Asia and having the CE Mark should accelerate those efforts."
The company said to comply with updated European medical device standards and to include design improvements, it is planing to file a second CE mark application later in 2012.