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July 25, 2014
08:07 EDTGTHPGuided Therapeutics files PMA amendment with FDA for LuViva Scan
Guided Therapeutics announced that it has filed an amendment to its premarket approval application with the U.S. Food and Drug Administration for the LuViva Advanced Cervical Scan. The filing follows the face-to-face meeting the company had with the FDA in May and addresses questions raised in a September 6, 2013 not-approvable letter that the company received from the agency. The FDA has 180 days to respond to the amendment. The company has regulatory approval to sell LuViva in Europe with the Edition 3 CE mark, and has marketing approvals from COFEPRIS in Mexico, Health Canada and Singapore Health Sciences Authority, among others. Additionally, expansion efforts are ongoing in the Middle East, Asia and Latin America.
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August 26, 2015
08:06 EDTGTHPGuided Therapeutics expands access of LuViva scan into Bulgaria
Guided Therapeutics has expanded access to the LuViva Advanced Cervical Scan to Bulgaria, bringing to 21 the number of countries where the company has shipped its non-invasive, point-of-care cervical cancer detection technology.
August 25, 2015
08:06 EDTGTHPGuided Therapeutics expands access of LuViva scan into Costa Rica
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