Smart Soft Healthcare Expands CoLumbo’s CE-Marked Capabilities with Broader Age Coverage and Advanced MRI Features
CoLumbo has received CE marking under the EU MDR, expanding its use to a broader adult population and adding enhanced capabilities for spine MRI analysis.
Smart Soft Healthcare is pleased to announce an important milestone for CoLumbo, its AI-powered software for spine MRI analysis. CoLumbo has received CE marking under the European Union Medical Device Regulation (MDR), confirming that the software meets the applicable EU requirements for medical devices.
The updated certification expands CoLumbo’s intended patient population by removing the previous upper age limit of 70 years. CoLumbo can now be used for adult patients aged 18 and above, ensuring that a broader range of patients can receive accurate and swift MRI spine image analysis.
This expanded indication further strengthens CoLumbo’s role as a medical imaging AI solution for radiologists, supporting automated analysis and measurements in lumbar spine MRI examinations.
CoLumbo has also expanded its capabilities to support the detection of thoracic-level abnormalities visible on lumbar spine MRI scans. This enhancement provides radiologists with additional information when reviewing examinations that include relevant anatomy beyond the lumbar spine.
The update reflects Smart Soft Healthcare’s continued focus on developing CoLumbo in response to evolving clinical needs and supporting radiologists with more comprehensive and efficient spine MRI analysis.
In addition, the latest version of CoLumbo supports the analysis of eligible postoperative spine MRI examinations without complications when contrast media has not been administered. This expanded functionality enables CoLumbo to assist radiologists in the assessment of a broader range of lumbar spine MRI examinations, including appropriate postoperative cases.
Through these updates, Smart Soft Healthcare continues to expand CoLumbo’s clinical capabilities while maintaining its focus on reliable, efficient, and AI-assisted MRI analysis for radiology workflows.