EDAP TMS SA submitted a 510(k) application for their Ablatherm Fusion device.
EDAP TMS SA (NASDAQ:EDAP) submitted a 510(k) application for their Ablatherm Fusion device, which enables a more precise method of targeting diagnosed areas within the prostate.
As quoted in the press release:
Marc Oczachowski, Chief Executive Officer of EDAP TMS, commented: “As recently mentioned, the next generation of Ablatherm devices merge MRI, 3D biopsy maps, and ultrasound images by integrating EDAP’s proprietary software and fusion algorithm. This innovative, state of the art option tremendously improves the imaging and targeting capabilities of the Ablatherm while maintaining its unique, proven tissue ablation efficacy.”
Marc Oczachowski added: ” Ablatherm Fusion is well positioned to perfectly complement our already commercialized range of HIFU devices and offerings. The submitted 510k file is straightforward as it maintains same treatment parameters from the previously approved current generation of Ablatherm devices.”