Edap (NSDQ:EDAP) said today it submitted a new FDA 510(k) application for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer after withdrawing its previous application in July.
The new application alllowed the France-based company to include a new set of clinical data, which it had decided to include following “advanced discussions” with the FDA earlier this year.
“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. As the new 510(k) application differs mainly within the clinical section, we will work closely with the agency to facilitate a straightforward review,” CEO Marc Oczachowski said in a prepared statement.
Early last month, Edap said it submitted an FDA 510(k) application for its next-gen Ablaterm Fusion device, 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.
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