CoLumbo

Smart Soft Healthcare

CoLumbo is an AI assistant software for the interpretation of lumbar spine MR scans. It is a deep learning algorithm that aims to help radiologists reduce the patient examination reading and reporting time, and increase the accuracy of measurements, and facilitate standardization in spine MRI reporting and increase the patient – physician communication and trust.

Information source: Vendor
Last updated: Aug. 19, 2023

General Information

General
Product name	CoLumbo
Company	Smart Soft Healthcare
Subspeciality	Spine
Modality	MR
Disease targeted	Disk herniation (Protrusion / Extrusion modifiers), Central Spinal Stenosis (CSS), Shizas and Lee morphological grading, decreased vertebral body heights, decreased disk height, hypo/hyperlordosis, nerve root impingement, listhesis
Key-features	Lumbar spine annotation, smart navigation, editable report, editable separate pathology report, measurement calculation based on segmentation
Suggested use	During: perception aid (prompting all abnormalities/results/heatmaps), interactive decision support (shows abnormalities/results only on demand), report suggestion

Technical Specifications

Data characteristics
Population	Europe - MRI lumbar spine studies, age – 18 to 70 (included) USA - MRI lumbar spine studies, age – 18+
Input	Lumbar spine MR, Magnetic Field Strength 1,5-3T. At least one sagittal T2w sequence containing 5 slices or more. Scanning Sequence – SE
Input format	DICOM
Output	Segmentation overlay, probability score per pathology, draft radiology report, image annotations, table of quantified values, list with measurements.
Output format	DICOM, DICOM PDF
Technology
Integration	Integration in standard reading environment (PACS), Integration via AI marketplace or distribution platform, Stand-alone third party application
Deployment	Locally on dedicated hardware, Locally virtualized (virtual machine, docker), Cloud-based
Trigger for analysis	Automatically, right after the image acquisition, On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time	10 - 60 seconds

Regulatory

Certification
CE	Certified, Class IIa , MDD
FDA	510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE)	The purpose of the device is to assist in reading MRI images of the lumbar spine and providing information on detected pathologies and abnormalities, as well as reducing the time to write the report. The results are reviewed and confirmed by a radiologist.

Market

Market presence
On market since	03-2021
Distribution channels	Incepto, CARPL.ai, deepcOS, Philips AI manager, Blackford, Osimis, Eureka Clinical AI
Countries present (clinical, non-research use)	9 (USA, Germany, Italy, France, Spain, Belgium, Netherlands, Austria, Switzerland)
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model	Pay-per-use, Subscription
Based on	Number of analyses

Evidence

Evidence
Peer reviewed papers on performance	Clinical Assessment of CoLumbo Deep Learning System for Central Canal Stenosis Diagnostics (read) Detection of Degenerative Changes on MR Images of the Lumbar Spine with a Convolutional Neural Network: A Feasibility Study (read)
Non-peer reviewed papers on performance
Other relevant papers