CoLumbo AI spine assistant receives an FDA 510(K) clearance


Smart Soft Healthcare is proud to announce, that after an extensive and thorough application process, CoLumbo becomes the world’s first lumbar spine AI software for MRI modality to receive an FDA 510(K) clearance. Obtaining an FDA clearance is an important milestone in the product development cycle, that will enable the CoLumbo expansion to the USA market and will benefit millions of patients with lumbar spine issues.

Working consistently towards innovation in radiology combined with the latest artificial intelligence algorithms is what Smart Soft Healthcare stands by. Our assistant software, CoLumbo, got clinically tested in three European hospitals and received a CE mark for clinical use. Since then, the progression has never stopped, and our team has been working on adding new segmentations and measurements and improving the software accuracy and reliability.

“CoLumbo is a powerful tool that impacts the quality and value of lumbar spine MR reporting, assisting in standardization, completeness and consistency.” – Lawrence Tanenbaum, M.D. FACR Chief Technology Officer, Vice President, RadNet Inc., USA

We promise that we will keep the tendency to improve and develop CoLumbo, continuing the successful path!


C01036 / 28.06.2022