June 24, 2025 —Smart Soft Healthcare has announced that CoLumbo, the company's advanced AI spine assistant, has received FDA 510(K) clearance for its latest version, Version 3. This achievement marks a significant milestone in CoLumbo's commitment to delivering cutting-edge AI solutions in radiology.
Building on its previous FDA clearance, CoLumbo Version 3 introduces support for DICOM images of patients that have scoliosis and fracture. With these new capabilities, CoLumbo now provides even more comprehensive assistance in measuring and reporting spinal conditions, ensuring greater reliability for radiologists and improved outcomes for patients.
This latest clearance not only strengthens CoLumbo’s position as a pioneering tool in lumbar spine MRI analysis but also broadens its scope of application.
"Receiving the long-waited FDA clearance for Version 3 of CoLumbo is a testament to our team’s relentless dedication to regulatory excellence. The new capabilities in supporting scoliosis and fracture are significant advancements that will enable us to better serve both healthcare professionals and patients. We are committed to maintaining the highest standards of safety, efficacy, and compliance as we continue to expand CoLumbo’s impact on the global market,” said Yoana Ivanova, Director of Regulatory Affairs, Smart Soft Healthcare
For additional information, please visit columbo.me.
November 20, 2025 
