SMAIO got FDA clearance for the Balance Analyzer 3D planning software for spine realignment.
Balance Analyzer 3D earned CE marking in 2014 and has been used with SMAIO's i-plan surgical planning product, according to a June 3 news release. The clearance is part of a partnership and licensing agreement the company signed with NuVasive.
"[The clearance] lays the foundations for the codevelopments the two companies have agreed to carry out over the next two years, and in the very near term will enable us both to initiate a certain number of technological and scientific collaborations with centers of excellence in the United States," Philippe Roussouly, CEO of SMAIO, said in the release.