LuViva Advanced Cervical Scan regulatory update

FDA said Guided Therapeutics’ PMA amendment for LuViva Advanced Cervical Scan non-invasive cervical cancer test was not approvable and said more patient data would be necessary. According to the company, FDA said it was willing to consider “alternative approaches to move the product to approvable form.” Guided Therapeutics plans to meet with the agency to discuss next steps. ...