Endra To Pursue De Novo Approval for Its TAEUS System for Liver Disease
Endra Life Sciences is switching its FDA application for its Thermo Acoustic Enhanced UltraSound (TAEUS) from the 510(k) marketing clearance pathway and is now seeking a de novo approval.
The company had submitted a 510(k) application for the TAEUS System, which is intended to characterize fatty liver tissue to noninvasively monitor nonalcoholic fatty liver disease, but switched to the de novo review pathway following discussions with the FDA.
The company said it will send the FDA additional confirmatory clinical data from a subset of its existing clinical evaluation sites, which it expects to receive this year. The device has already received CE mark certification.
De novo devices are those for which there are no legally marketed devices of the same type, while 510(k) applications are based on an existing “reference” product already on the market.