Optical Diagnostic Systems, LLC (ODS) is a U.S. limited liability company with administrative offices located in Pittsburgh, Pennsylvania. ODS owns the intellectual property and worldwide distribution rights of the CRAINSCAN, a portable optical measuring device that detects epidural, subdural or superficially intracerebral hemorrhages. Manufacturing of the CRAINSCAN remains under contractual agreement with Bytec, Stolberg, Germany.
Looking to the future …
- CRAINSCAN has met all the necessary requirements and received the CE marking.
- The second-generation device is being developed in the U.S.
- ODS will conduct clinical studies at U.S. tertiary hospital(s) in anticipation of gaining U.S. FDA approval in 2014.
- Once U.S. FDA approval has been granted, ODS will contract with a manufacturer in the U.S. to produce the second-generation device.
Once U.S. FDA approval is granted, ODS will contract with a manufacturer in the U.S. to produce the second-generation device.