CEO Marc Oczachowski says, "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."
Focal One is a robot-assisted high-intensity focused ultrasound (HIFU) system used to for focal therapy for prostate cancer.
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