EDAP submits FDA 510(k) for Ablatherm Fusion HIFU device

Edap (NSDQ:EDAP) said this week it submitted an FDA 510(k) application for its next-gen Ablaterm Fusion device.

The Lyon, France-based company’s next-generation Ablatherm Fusion is a robotic high-intensity focused ultrasound device designed to allow urologists to import pre-treatment diagnostic info, including MRI images and 3D biopsy maps, and merge them with live ultrasound images during prostate tissue ablation procedures.

The device features the company’s proprietary fusion algorithm, and is designed to be used with its existing range of HIFU devices.

“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. 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,” CEO Marc Oczachowski said in an SEC filing.

The submission comes less than a month after EDAP said it withdrew the FDA 510(k) application for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer.

The company said that following “advanced discussions” with the federal watchdog, it plans to submit a new 510(k) application which includes new clinical data.