Electro-Optical Sciences, Inc. announced that its Pre-Market Approval (PMA) application for MelaFind has been formally accepted for filing by the US FDA. MelaFind is a non-invasive and objective computer vision system intended to aid in the early detection of melanoma. The US FDA's action meant that the PMA application was sufficiently complete and ready for substantive review. The filing date for regulatory purposes is June 9, 2009 that is the date when the FDA received EOS' PMA submission. The FDA has also confirmed that the PMA application will receive expedited review and processing.
We’re extremely pleased that the FDA has formally accepted the MelaFind PMA for review. This brings us one step closer to realizing our goal of offering clinicians a reliable tool to help them to detect melanoma while it is still in its earliest, most curable stages, said Joseph V. Gulfo, M.D., President and CEO. We look forward to advancing our discussions with the FDA and obtaining the agency’s feedback on the MelaFind PMA and next steps in the review process.