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Laser mammography firm targets Europe
Imaging Diagnostic Systems could soon make the jump from a development-stage company to a full-fledged vendor of medical systems. The company has received regulatory approval to apply the CE Mark to its computed tomography laser mammography (CTLM) system
Imaging Diagnostic Systems could soon make the jump from a development-stage company to a full-fledged vendor of medical systems. The company has received regulatory approval to apply the CE Mark to its computed tomography laser mammography (CTLM) system and is now clear to begin marketing the product in countries in the European Union.
The CE mark is accepted in other parts of the world, the company noted, but not the U.S., where CTLM is awaiting FDA review as part of the premarket approval process. The application is expected to be complete early this year. Imaging Diagnostic Systems is seeking a PMA for the system to be used as an adjunct to conventional mammography and for clinical examination to aid in the detection of breast abnormalities.
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