Press Releases

Press Releases

Date Title and Summary Additional Formats
Toggle Summary EDAP Announces End of the Year Focal One® Sales
Among December deals closed, two major US institutions have purchased Focal On   University of California, San Francisco Medical Center and Cleveland Clinic become latest to adopt Focal One high intensity focused ultrasound (HIFU) technology   Sales include a bundled sale with ExactVuTM as well as
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Toggle Summary EDAP Announces European Association of Urology Recommends HIFU for Treatment of Localized Prostate Cancer
Both Primary and Salvage HIFU Treatments Recommended in 2014 EAU Guidelines on Prostate Cancer
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Toggle Summary EDAP Announces Exclusive Distribution Agreement with Leading Italian Medical Device Distributor AB Medica
Partnership further extends the availability of EDAP’s High Intensity Focused Ultrasound (HIFU) technology to one of the largest markets in Europe Complementary to AB Medica’s extensive product portfolio which includes robotic surgery solutions as well as ExactVu LYON, France , November 17, 2020 --
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Toggle Summary EDAP ANNOUNCES EXCLUSIVE WORLDWIDE DISTRIBUTION RIGHTS TO EXACT IMAGING’S MICRO-ULTRASOUND TECHNOLOGIES
Exact Imaging is a leading developer of ultra-high-resolution micro-ultrasound diagnostic technologies Micro-ultrasound ExactVu™ is the only ultrasound-based imaging tool with published data demonstrating prostate cancer diagnostic capabilities similar to MRI Combination of Exact Imaging’s
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Toggle Summary EDAP Announces FDA Breakthrough Device Designation for Focal One® in the Treatment of Deep Infiltrating Rectal Endometriosis
Focal One HIFU has potential to address large market impacting thousands of women each year LYON, France, March 4, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that its Focal One platform has been granted Breakthrough Device designation by
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Toggle Summary EDAP Announces FDA Clearance of its Ablatherm-Fusion® device
LYON, France , October 4, 2017 -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced FDA approval of its Ablatherm-Fusion device enabling a more precise method for targeting of diagnosed areas within the prostate. Marc Oczachowski , Chief Executive Officer of
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Toggle Summary EDAP Announces filing of 510(k) Application for Ablatherm-Fusion® device
LYON, France , July 31, 2017 -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that the Company submitted a 510(k) application for its Ablatherm Fusion device, enabling a more precise method for targeting of diagnosed areas within the prostate.
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Toggle Summary EDAP Announces Filing of New 510(k) Application for Focal One® Device
510(k) Includes New Clinical Data to Support EDAP's File LYON, France , September 11, 2017 -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that the Company submitted a new 510(k) application for its Focal One device, including an updated clinical section
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Toggle Summary EDAP Announces Final Results from HIFI Study Comparing Outcomes of Focal One® HIFU Versus Radical Prostatectomy to be Presented During Plenary Session at the Upcoming 119th American Urological Association (AUA) Annual Meeting
LYON, France, April 23, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced that final results from the HIFI Study, the largest clinical trial ever conducted comparing EDAP’s Focal One robotic high intensity focused ultrasound (HIFU) versus radical
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Toggle Summary EDAP Announces Final U.S. 2021 Reimbursement Rules for High Intensity Focused Ultrasound (HIFU)
   Final rules establish, for the first time, a Category 1 CPT code and reimbursement to physicians performing ablation of malignant prostate tissue with HIFU in the US Physician reimbursement for HIFU approximately 30% higher than cryotherapy and brachytherapy Hospital reimbursement for HIFU up
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