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.
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.
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.
Guided Therapeutics, Inc. (OTCQB: GTHP) reported today that the Company received Regulatory Approval from the Indian Ministry of Health & Family Welfare to allow commercialization of the LuViva device and disposables. The Ministry concluded that the LuViva...
Technology gaining momentum in 4th largest market Guided Therapeutics, Inc. (OTCQB: GTHP), developer of the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly at the point of care, today announced it has received...