LuViva is indicated for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases, involves taking a biopsy of the cervix.
Used in conjunction with the LuViva cervical guide single-use patient interface and calibration disposable, the diagnostic device scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue.
LuViva, which does not require laboratory analysis or a tissue sample, provides results immediately.
Guided Therapeutics CEO Gene Cartwright said that the approval to sell LuViva in Mexico is a significant milestone for the company and opens up the second largest market for medical products in Latin America.
"We will be working with Dantien5 Medical, our distributor in Mexico, to promote LuViva for the detection of cervical cancer, a tremendous unmet need in this part of the world," Cartwright added.
Dantien5 Medical director Carlos Lugo said that cervical cancer is a large problem in Mexico with limited access to health care which contributes to a high national mortality rate.
"As a result, we are actively working on practical evaluations to expedite availability of this early detection technology to Mexican women," Lugo added.
"After a recent successful meeting with the Principal Investigator at a key facility, we expect the evaluation to begin this quarter."
Guided Therapeutics recently introduced the LuViva at the XIX Congress of the Mexican College of Obstetrics and Gynecology Specialists in Mexico City.