EDAP TMS announced the submission of a new 510(k) application for its Focal One device, including an updated clinical section for FDA review.
EDAP TMS (NASDAQ:EDAP) announced the submission of a new 510(k) application for its Focal One device, including an updated clinical section for FDA review.
As quoted in the press release:
As reported on July 17, 2017, the Company decided to withdraw its existing Focal One 510(k) application to allow the inclusion of a new set of clinical data.
Marc Oczachowski, Chief Executive Officer of EDAP TMS, commented: “The new 510k review may be more efficient as the updates only pertain to the clinical section which includes new studies from active and academic Focal One centers in Europe. Our regulatory and clinical teams have been working diligently to gather the new set of data.”
Marc Oczachowski added: “As the new 510(k) application differs mainly within the clinical section, we will work closely with the agency to facilitate a straightforward review.”