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.