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ENDRA Life Sciences Provides Update on FDA Regulatory Timeline
Company guides to Q2:20 submission of 510(k) with robust filing packageANN ARBOR, MI / ACCESSWIRE / March 19, 2020 / ENDRA Life Sciences Inc. ("ENDRA")
About this update from Endra Life Sciences Inc.
[{"type":"text","content":"Company guides to Q2:20 submission of 510(k) with robust filing packageANN ARBOR, MI / ACCESSWIRE / March 19, 2020 / ENDRA Life Sciences Inc. (\"ENDRA\") (NASDAQ:NDRA), the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), announced further details on the expected timing of its planned TAEUS Fatty Liver Imaging Probe (FLIP) device 510(k) regulatory submission to the U.S. Food and Drug Administration (the \"FDA\"). The company previously communicated that it had anticipated filing a 510(k) submission during H1, and is now more specifically guiding to an expected Q2:20 submission.\"ENDRA's rigor with the European regulatory process yielded a successful outcome with the receipt of the CE Mark earlier than planned, in March. The CE Mark enables commercialization of ENDRA's TAEUS liver device in Europe,\" said Francois Michelon, CEO of ENDRA.\"We are in the process of finalizing a robust 510(k) regulatory package, which includes some additional verification testing that was conducted during Q1,\" continued Michelon. \"The purpose of this testing was to further bolster our submission package, and ensure that we meet the FDA requirements for a 510(k) premarket notification filing. A Q2 submission positions us to receive approval of TAEUS FLIP in the U.S. in H2, and to initiate U.S. commercial activities in 2020.\"ENDRA expects the TAEUS FLIP device will be classified as a Class II device, which is typically \"cleared to market\" by the FDA through the 510(k) submission process and an FDA substantial equivalence decision of safety and performance as a legally marketed device or devices (\"predicate\").ENDRA, with support of regulatory consultants experienced with the FDA submission process, has continued to assess potential 510(k) predicate devices for ENDRA's proprietary combination of existing imaging technologies, to demonstrate substantial equivalence. In early 2020, ENDRA became aware of a recently cleared 510(k) submission for a device that ENDRA believes offers some regulatory advantages as a predicate, helping to mitigate regulatory clearance risk. As a result, the company has decided to invest additional time in verification testing to support demonstration of substantial equivalence.Ultimately, ENDRA believes this additional verification testing will yield the strongest possible FDA submission for ENDRA's TAEUS liver de...