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FDA Clears ESC Medical's GyneLase for Trials

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YOKNEAM, Israel, Aug. 15 -- ESC Medical Systems Ltd. has won approval from the US Food and Drug Administration to test its GyneLase diode laser system for the treatment of extreme menstrual bleeding (menorrhagia). The company intends to begin clinical Phase III trials during the fourth quarter and market GyneLase in about 18 months, pending final FDA approval. GyneLase is a second-generation global endometrial ablation light-based system that uses a procedure known as Endometrial Laser Intrauterine Thermal Therapy (ELITT). The system comprises a small portable tabletop laser and disposable...Read full article

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    Published: August 2000
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