Guided Therapeutics has responded to the US Food and Drug Administration's (FDA) not-approvable letter of LuViva Advanced Cervical scan.
The company provided additional information of LuViva Advanced Cervical scan as requested by the agency.
The company also provided additional safety testing information of LuViva scan in support of the application for the CE mark as requested by its reviewer.
Guided Therapeutics president and CEO Mark Faupel said the company believes that by working with FDA, it can achieve approval for LuViva and provide women with access to new technological advancements to detect cervical disease at an earlier stage, when it can be better treated.
"We also believe that LuViva remains on track to receive the CE mark in the second quarter," Faupel added.
"We continue to build up our international distribution network and introduce LuViva to the medical community at various medical conferences in anticipation of a product launch in the second half of 2012."