ENDRA Life Sciences Inc (NASDAQ: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.
