FDA Sets Nov. 30 Meeting for Guided’s LuViva Device

The FDA has set a Nov. 30 meeting to review Guided Therapeutics’ plan for its LuViva Advanced Cervical Scan, a noninvasive cancer detection product.

In May, the FDA rejected a July 2014 amendment to the device’s PMA application, citing a need for more patient data before signing off. A key objective of the upcoming meeting will be to determine the parameters of the additional patient data.

Guided sent a presubmission letter to the FDA in August containing plans for a confirmatory study for the company to collect additional data scans on patients (IDDM, Aug. 18).

The meeting was scheduled for Nov. 6, but Guided requested a new date to accommodate the schedules of two physicians who plan to attend the meeting on the company’s behalf. Both doctors are principal investigators of the LuViva pivotal clinical trial.

LuViva is a noninvasive device that uses spectroscopy to measure light interaction with tissue to identify chemical and structural markers for cervical cancer.

It is approved in Europe, Canada and Mexico and is currently available to women in 20 countries. — Jonathon Shacat