Key Developments For EDAP TMS SA
EDAP TMS SA (EDAP.O) (Consolidated Issue listed on NASDAQ Global Market)
EDAP TMS S.A. Secures First U.S. Sonolith I-Sys Device Sale
EDAP TMS S.A. announced the first order for its Sonolith I-Sys lithotripsy device from a major U.S. lithotripsy player.
EDAP TMS S.A. To Participate In HIFU Liver Cancer Trial
EDAP TMS S.A. announced that the French regulatory organization AFSSAPS has authorized a Phase I clinical study to evaluate High Intensity Focused Ultrasound (HIFU) technology in patients with metastatic liver cancer. HIFU has the potential to assist with liver ablations and reduce bleeding during surgery. Over the next six months, 20 patients are expected to receive treatment with a HIFU-based device designed to help destroy hepatic metastasis, or liver cancer tumors, while preserving surrounding tissues and organs. The objective is to expand the number of patients eligible for surgery and extend the survival rate. The device was jointly developed by EDAP in collaboration with Centre Leon Berard (a national Lyon, France-based cancer center) and INSERM 556 Unit with the financial support from CLARA and OSEO, organizations respectively dedicated to supporting cancer treatment initiatives and technological innovation.
EDAP TMS S.A. Receives U.S. FDA 510(k) Approval For Sonolith I-Sys
EDAP TMS S.A. announced that the U.S. Food and Drug Administration has granted 510(k) marketing clearance for its newly designed, high-end Sonolith I-Sys device.
EDAP TMS S.A. Receives FDA Permission to Amend Ongoing Ablatherm-HIFU U.S. Clinical Study Protocol
EDAP TMS S.A. announced that the U.S. Food and Drug Administration (FDA) approved the following protocol amendments for the Company's ongoing U.S. clinical study of Ablatherm-HIFU (high intensity focused ultrasound) for the treatment of patients with localized prostate cancer:
EDAP TMS S.A. Installs First Ablatherm-HIFU Device in Mexico
EDAP TMS S.A. announced the first installation of its Ablatherm-HIFU (high intensity focused ultrasound) machine at Centro Medico Puerta de Hierro Hospital in Guadalajara, Mexico. The clinic adopted the Ablatherm robotic HIFU system through a revenue per procedure (RPP) contract.
