ENDRA Life Voluntarily Withdraws 510(k) Application For Liver Fat Measuring System

ENDRA Life Sciences Inc NDRA plans to voluntarily withdraw its 510(k) application, currently under FDA review for its TAEUS System. Instead, the Company will subsequently submit a De Novo application.

• TAEUS is initially focused on measuring fat in the liver as a means to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD).
• ENDRA intends to leverage clinical data from a subset of its existing global clinical study partnerships to support the De Novo request. 
• Each clinical site will be screening patients with MRI-PDFF (magnetic resonance imaging proton density fat fraction) and TAEUS and then comparing the results from the two modalities. 
• ENDRA seeks to generate the additional data required for the De Novo process as rapidly as possible in 2022.
• Unlike a 510(k) clearance in which FDA determines "substantial equivalence" between a new product and another commercially available product, the De Novo process provides a pathway for low-to-moderate risk medical devices that do not have a marketed predicate device. 
• Price Action: NDRA shares are down 27.1% at $0.41 during the premarket session on the last check Thursday.