EDAP TMS withdraws 510(k) application for Focal One device
EDAP TMS announced that the company has withdrawn the 510(k) application for its Focal One device currently under review by the FDA. Following advanced discussions with the agency, EDAP plans to submit a new 510(k) file including new clinical data. Marc Oczachowski, CEO of EDAP TMS, commented, "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."