Don't you feel like the statement was to be expected? If they had FDA approval already they would have had to disclose, so they clearly didn't have it. The comment was;
"In parallel with advancing our commercial plan in Europe, we continue to engage actively with the FDA regarding the TAEUS system's 510(k) submission. We are working collaboratively with the Agency for agreement on a definitive path forward, including potentially providing additional real-world clinical data, as the review period has taken longer than we expected," stated Francois Michelon, Chairman and Chief Executive Officer of ENDRA.
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