Guided Therapeutics reopens communications with FDA for LuViva
Guided Therapeutics announced that it has re-opened discussions with the U.S. Food and Drug Administration regarding U.S. premarket approval of the Company's LuViva Advanced Cervical Scan. The company's decision was prompted by a constructive outcome from the company's previous face-to-face meeting with FDA and a perceived more favorable environment for device approvals under the new presidential administration, along with a recent increase in device approvals at the FDA. In connection with the company's plan to re-file for approval of its LuViva Advanced Cervical Scan, it plans on conducting a new clinical study to confirm previous results already submitted to the FDA. In a telephonic meeting with the FDA, the company discussed initiating the process by submitting a new study protocol and discussed the possibility of submitting the study data under FDA's 510(k) de Novo regulations, which, if accepted, could potentially speed up the approval process. The new clinical study is expected take approximately nine months to complete, after which the company would submit the data to the FDA. The company intends on initiating the process by submitting the new study protocol to the FDA within 30 days after funding has been secured. Once final clinical study data has been submitted to the FDA, the FDA will have 180 days to respond with a decision or additional questions.