The French company said that following “advanced discussions” with the federal watchdog, it plans to submit a new 510(k) application which includes new clinical data.
“As mentioned during our last quarterly call, a shift in biopsy protocol has created difficulties in comparing biopsy data under the current 510k application. We actively worked with some of our key users in Europe to gather new and additional clinical data on Focal One in order to provide them to the agency for review. It is not possible to include this new clinical data in our current file under review, and thus need to withdraw our current application and submit a new 510(k) with the new set of clinical data, which will be filed very soon. We remain committed to having our HIFU Focal One device FDA cleared as rapidly as possible. With the exception of the new clinical data, the new application remains unchanged. In our effort to continue to continue making our HIFU technology and devices available in the U.S., we will also submit a 510(k) filing to the FDA for the clearance of our Ablatherm Fusion device in the near future, enabling American patients to benefit from the latest innovations in prostate tissue ablation with HIFU,” CEO Marc Oczachowski said in an SEC filing.
In May, EDAP said that the Centers for Medicare & Medicaid Services established reimbursement billing codes for high intensity focused ultrasound ablation procedures for prostate tissue.