Aurora AEYE FDA Process Update
Optomed Plc Press Release 15 November 2022 at 16.00, Helsinki Aurora AEYE FDA Process Update Optomed and its partner AEYE Health have a common goal to obtain the US FDA clearance for the handheld AI fundus camera Aurora AEYE. Currently, the companies expect that they are able to address the latest feedback from the FDA in the coming months after which they will revert back to the agency. Optomed announced the results from the prospective, multi-center clinical trial intended to assess its handheld fundus camera Aurora together with AEYE Health’s AI for autonomous detection of