SMAIO has received US Food and Drug Administration (FDA) 510(k) clearance for its Balance Analyzer 3D surgery planning software.
Balance Analyzer 3D is spinal realignment planning software using medical imaging of the patient’s spine. Since receiving CE marking in 2014, it has been an integral part of the i-plan surgical planning solution marketed by SMAIO within its i-kontrol platform that aims to allow surgeons to treat spinal pathologies in a safe, effective and lasting way.
Philippe Roussouly, CEO of SMAIO, said: “This 510(k) clearance for the current version of our Balance Analyzer 3D planning software represents a major step in our American market penetration strategy that will be based, in the coming years, on our partnership with NuVasive.
“It lays the foundations for the co-developments 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 centres of excellence in the United States.
“This clearance illustrates the added value of SMAIO’s project that aims to develop, globally, the most cutting-edge solution for planning and performing spine surgery taking into account the specificities of each patient.”
According to a company press release, obtaining 510(k) clearance from the FDA is a key element of the partnership and licensing agreement signed in Q1 2022 between SMAIO and NuVasive.