Guided Therapeutics (OTC:GTHP) said today it re-entered discussions with the FDA about pursuing premarket approval for its LuViva advanced cervical scan device.
The Norcross, Ga.-based company said the decision was prompted by “constructive” outcomes from previous meetings with the organization alongside a “perceived more favorable environment for device approvals under the new presidential administration” and a recent increase in FDA device approvals.
As part of the plans to re-file for approval with the LuViva, the company said it is planning to launch a new clinical study of the device to confirm previous results which it had already submitted to the FDA, according to a press release.
Guided Therapeutics said that it discussed initiating the process in a telephone meeting with the FDA, and may look to submit study data under the Agency’s 510(k) de novo regulations, which could potentially hasten the process.
The new study is expected to take 9 months to complete, the company said, adding that it hopes to initiate the process by submitting a new study protocol to the FDA within 30 days of securing funding.
In March, Guided Therapeutics said it inked an exclusive licensing agreement with Shandong Yaohua Medical Instrument Corp., to manufacture its LuViva advanced cervical scan system and related disposables. The deal also gives SMI exclusive distribution rights in China, Macau, Hong Kong and Taiwan.
