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Guided Therapeutics Reports After Meeting with FDA They Will Start Study in Support of its Application for FDA Approval

The purpose of the meeting was to finalize the protocol (procedure) for its new clinical study in support of its Premarketing Application for the LuViva® Advanced Cervical Scan (i.e., FDA approval). The Company filed the minutes from this meeting with FDA yesterday, which the agency will review and provide any final comments on the meeting and study protocol.

Guided Therapeutics Submits Clinical Study Protocol to U.S. FDA for LuViva® Advanced Cervical Scan

LuViva will be studied to assess its ability to help detect a significant number of the up to 40% to 50% cases missed at the point of biopsy because of limitations in current imaging technology.

LuViva Advanced Cervical Span Awarded New CE Mark with Expanded Claims

The new CE Mark includes expanded claims for the use of LuViva by physicians for the early detection of cervical cancer.

Guided Therapeutics Inc. Receives $2.5 Million Purchase Order from Chinese Partner Shandong Medical Device Technology Company

4/2/19: Guided Therapeutics Inc. reports the purchase order includes parts for final assembly of LuViva along with single use disposables that are consumed with each LuViva test. Approximately 25% of the purchase order will be paid upon Shandong’s filing with the Chinese FDA with the remainder due once Chinese FDA approval is obtained, which is expected within about one year.

New Data Released at European Conference Demonstrates LuViva® Advanced Cervical Scan Detects Cervical Cancer Earlier than Pap and HPV tests

5/22/18: According to Dr. Zoltan Hernadi of the University of Debrecen in Hungary, “We were impressed by cases in which both the Pap and HPV tests were negative but LuViva was positive and the patient was later found by her biopsy result to be developing cervical cancer. This clearly demonstrates the value of LuViva for the early detection of cervical cancer.”

Guided Therapeutics Achieves Regulatory Approval for Sale in India

Guided Therapeutics, Inc. (OTCQB: GTHP) reported today that the Company received Regulatory Approval from the Indian Ministry...

Guided Therapeutics Receives Order for 10 LuViva® Advanced Cervical Scans for Indonesia

Technology gaining momentum in 4th largest market Guided Therapeutics, Inc. (OTCQB: GTHP), developer of the LuViva® Advanced Cervical...