CoLumbo

by Smart Soft Healthcare  · Based in Bulgaria → — Leader in AI Lumbar Spine MRI Analysis
Neurosurgery Orthopedics Radiology
Claim this tool
Is this the maker? Claim the company →

Regulatory Status Disclosed

Overview

CoLumbo, developed by Smart Soft Healthcare, is an advanced AI assistant software designed for the interpretation and analysis of lumbar spine MRI scans. It leverages deep learning algorithms, specifically fully convolutional neural networks with U-Net-like architecture, to enhance the efficiency and accuracy of radiologists.

The software automatically segments major structures of the lumbar spine, calculates various measurements (distances, areas, angles), and identifies key points in the images. It provides a detailed description of findings in an editable draft report, aiming to reduce patient examination reading and reporting time by up to 25-32% and decrease errors of omission by up to 15%.

CoLumbo has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a CE Mark certification for clinical use in Europe, making it an approved AI solution for L-spine MRI images in these regions. Version 3 of CoLumbo further expands its capabilities by introducing support for DICOM images of patients with scoliosis and fracture.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automatic segmentation of lumbar spine structures
  • Measurement calculation based on segmentation (distances, areas, angles)
  • Editable draft radiology report generation
  • Identification of pathologies and abnormalities (e.g., herniation, stenosis, listhesis)
  • Smart navigation for image review
  • Segmentation overlay and probability scores per pathology
  • Image annotations
  • Table of quantified values and measurements
  • Fully customizable thresholds for pathology detection
  • Reports available in multiple languages (English, German, French, and more)

Use Cases

  • Reducing MRI reading and reporting time for radiologists
  • Increasing accuracy of measurements in lumbar spine MRI analysis
  • Facilitating standardization in spine MRI reporting
  • Assisting in the interpretation of complex lumbar spine MR scans
  • Improving patient-physician communication through detailed reports
  • Supporting legal professionals in personal injury cases with objective MRI analysis

What Physicians Need to Know

DICOM Support & Standards
Supports standard DICOM input and outputs DICOM and DICOM PDF, including DICOM SC for integration.
PACS Integration Method
Integrates into standard PACS environments, via AI marketplaces (e.g., Sectra Amplifier, Nuance Precision Imaging Network, TeraRecon Eureka Clinical AI), and supports worklist integration. Reports can be sent as DICOM PDF to PACS or RIS.
Reading Room Workflow Impact
Significantly reduces MRI reporting time by up to 25-60% (e.g., from ~23 mins to ~9 mins per study) and errors of omission by up to 15%. It provides editable, pre-populated draft reports, segmentations, measurements, and annotations, enhancing standardization and diagnostic consistency.
AI Model Architecture
Utilizes a deep learning algorithm, specifically fully convolutional neural networks with a U-Net-like architecture, for pixel-level segmentation and key point identification. It combines multiple 2D CNNs into a 3D ensemble.
Processing Speed (per study)
While specific AI processing speed per study is not explicitly detailed, studies indicate a significant reduction in radiologist reporting time from approximately 23 minutes to 9 minutes per MRI study with AI assistance.
FDA Clearance Pathway
Received FDA 510(K) clearance, with the initial clearance in 2022. Version 3 further expanded support to include scoliosis and fracture. It is cleared as an assistant diagnostic tool in the EU and an assistant measurement tool in the USA.
Supported Modalities
Primarily supports lumbar spine MRI scans (1.5T-3T). Version 3 added support for scoliosis and fracture. It does not support CT, X-ray, or US, and has limitations for contrast media, pregnancy, and post-operational complications.
Sensitivity & Specificity Data
For central spinal stenosis, reported sensitivity is 92.70% and specificity is 99.04%. Overall accuracy for various pathologies includes 100% for intervertebral disc detection, 87% for disc herniation, 98% for spinal canal stenosis, and 91% for nerve root compression. Radiologists using CoLumbo demonstrated higher accuracy and agreement.
RSNA/ACR Validation
Successfully passed clinical trials in multiple European and US medical centers. A study on its impact on reporting time and diagnostic accuracy was presented at RSNA. CoLumbo was ranked #1 in the MICCAI IVDM3Seg-Segmentation Challenge.
Physician Tip

CoLumbo acts as an intelligent assistant, significantly streamlining lumbar spine MRI interpretation by providing automated segmentations, measurements, and pre-populated, editable reports. This can lead to substantial time savings (up to 60%) and a reduction in errors of omission (up to 15%), particularly beneficial for generalists and residents. Leverage its standardization capabilities for consistent reporting across multiple sites. Remember, CoLumbo is a tool to assist and enhance your diagnostic process, not replace your expert judgment; always review and confirm its findings, and customize thresholds to fit your practice.

CoLumbo offers flexible integration options, including direct integration with standard PACS environments and through leading AI marketplaces like Sectra Amplifier, Nuance Precision Imaging Network, and TeraRecon Eureka Clinical AI. It supports DICOM input and output (including DICOM SC) and worklist integration, ensuring seamless workflow incorporation. Deployment can be cloud-based, locally on dedicated hardware, or locally virtualized (VM, Docker), providing adaptability to various IT infrastructures. Ensure your PACS version is compatible with the highlighted integration standards.

Details

Category Radiology & Imaging AI
Pricing Unknown
DeploymentCloud
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

CoLumbo received 510(k) clearance from the U.S. Food and Drug Administration (FDA) as an image postprocessing and measurement application for quantitative measurements from MR images of the lumbar spine. Version 3 also received 510(k) clearance, introducing support for DICOM images of patients with scoliosis and fracture.
Integrations
EHR Not specified
Specialties Neurosurgery, Orthopedics, Radiology

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate CoLumbo

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

CoLumbo
CoLumbo AI spine assistant receives an FDA 510(K) clearance
Smart Soft Healthcare announced that CoLumbo, an AI software for lumbar spine MRI, received FDA 510(K) clearance, enabling its expansion into the USA market. This milestone follows clinical testing in European hospitals and a CE mark for clinical use.
2022-06
Imaging Technology News
AI Spine Assistant Software Tool Receives FDA Clearance | Imaging Technology News
CoLumbo, an advanced AI spine assistant from Smart Soft Healthcare, received FDA 510(K) clearance for its Version 3, which now supports DICOM images of patients with scoliosis and fractures. This expands its capabilities in measuring and reporting spinal conditions.
2025-06
CoLumbo
CoLumbo AI Spine Assistant Secures FDA 510(K) Clearance for Version 3.0
Smart Soft Healthcare announced FDA 510(K) clearance for CoLumbo Version 3, which includes new capabilities for supporting scoliosis and fracture in DICOM images, enhancing its role as a pioneering tool in lumbar spine MRI analysis.
unknown
AuntMinnie
Smart Soft gets FDA clearance for CoLumbo software - AuntMinnie
Smart Soft Healthcare received 510(k) clearance from the FDA for CoLumbo, an image postprocessing and measurement application for lumbar spine MR images, marking an important step for its U.S. market expansion.
2022-07
unknown
CoLumbo raises u20ac2.1M to bring its AI-based assistance software to European radiologists
CoLumbo, a Varna-based software for L-spine image analysis, secured u20ac2.1 million in funding from Eleven Ventures, BrightCap Ventures, and angel investors to expand its AI-based assistance software to European radiologists.
2022-02
unknown
CoLumbo and Nuance collaborate to advance AI in medical imaging
Smart Soft Healthcare, developer of CoLumbo, announced a collaboration with Nuance, a Microsoft company, to integrate CoLumbo with Nuance Precision Imaging Network (PIN) to advance diagnostic imaging and clinical workflows across the USA.
2024-03
unknown
Pioneering AI solutions in spine imaging with Nedelcho Georgiev, the CEO of CoLumbo
Nedelcho Georgiev, CEO and Founder of CoLumbo, discusses the company's journey to revolutionize patient care through AI in spine imaging, aiming for significant time savings and error reduction for radiologists.
2024-02
CoLumbo
CoLumbo joins Harrison.ai Open Platform to advance collaborative innovation in imaging AI
Smart Soft Healthcare has partnered with Harrison.ai through its new Open Platform, integrating CoLumbo to foster collaborative innovation in imaging AI.
2025-11

Videos

Product demos, reviews, and walkthroughs for CoLumbo.

View all on YouTube

Frequently Asked Questions

CoLumbo is an AI assistant software designed to integrate seamlessly into standard reading environments like PACS, or via AI marketplaces and distribution platforms. Its primary function is to analyze lumbar spine MRI images, providing automatic segmentations, measurements, and a pre-populated, editable draft report to assist radiologists.
CoLumbo detects and quantifies common pathologies such as disk herniation, central spinal stenosis (with Schizas and Lee morphological grading), decreased vertebral body and disk heights, hypo/hyperlordosis, nerve root impingement, and listhesis. Clinical trials indicate that radiologists using CoLumbo can be more accurate, reducing errors of omission by up to 15%.
CoLumbo has obtained CE mark certification and FDA 510(K) clearance, making it a fully approved AI solution for L-spine MR images for clinical use in both the USA and Europe. It is classified as a regulated health product (Class IIa) and also holds TGA clearance.
While CoLumbo focuses specifically on lumbar spine MRI analysis, broader healthcare analytics and medical imaging AI markets offer alternatives. Some listed competitors or similar applications include QGenda Advanced Scheduling for Providers, Waystar, Personify Health, Definitive Healthcare, and Oracle Enterprise Healthcare Analytics, though these may cover different aspects of healthcare operations or broader imaging modalities.
CoLumbo is an assistant software and does not replace the need for human radiologist interpretation; its results are meant to be reviewed and confirmed by a radiologist. While it significantly reduces reporting time and errors, it is a diagnostic tool that should not be used alone to recommend medical care.
The specific pricing or licensing model for CoLumbo is not publicly detailed in the provided information. However, the company aims to offer a low-cost solution to expand accessibility and reduce the economic burden on healthcare systems. Interested institutions would typically need to request a demo or contact the vendor for pricing details.

Related Tools

HeartLung AI-CVD®
HeartLung Corporation
Cardiology AI
HeartLung AI-CVD® is an FDA-cleared AI-powered quantitative imaging tool that provides automated CT-derived measurements for assessing cardiovascular and multisystem risks opportunistically.
Enterprise
Heartvue.Proton
Heartvue.ai
Cardiology AI
Heartvue.ai provides AI-powered software for automating cardiac MRI analysis and optimizing echocardiography documentation and revenue.
Enterprise
Cleerly
Cleerly, Inc.
Cardiology AI
Cleerly is an FDA-cleared AI platform that analyzes coronary CT scans to quantify plaque volume, characterize plaque morphology, and assess ischemia.
Enterprise
OCTA
OCTA
Clinical Decision Support & Reference
OCTA Flow is an AI-powered platform that assists ophthalmologists in analyzing Optical Coherence Tomography Angiography (OCTA) scans to enhance diagnostic accuracy and efficiency.
Starts from $0/month (free plan) to $2,999/month (lead plan) for octa core.
Smart Reporting
Smart Reporting
Clinical Decision Support & Reference
A German health tech startup uses artificial intelligence to cut time spent on medical reports and improve patient care. Founded by a radiologist, Smart Reporting aims to standardize reporting and minimize documentation time, addressing the looming threat of physician shortage in Europe.
RetiVue EntireEye Imaging
RetiVue, LLC
Ophthalmology AI
RetiVue manufactures ultrawidefield retinal cameras with automatic image capture, aiming to aid in the early documentation of eye disease and prevent blindness. Their EntireEye Imaging System offers both desktop and portable options, providing true color, high-detail images with a wide field of view for patients from infancy to adulthood.
Paid

See all Radiology & Imaging AI tools →

More from Smart Soft Healthcare

CoLumboX
Smart Soft Healthcare AD
Clinical Decision Support & Reference
CoLumboX is an FDA-cleared AI software by Smart Soft Healthcare AD for lumbar spine MRI analysis, assisting radiologists with automated measurements and reporting to enhance efficiency and accuracy.
Contact vendor

View company profile →

Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
AI Tool Finder
AI-powered search. Results may not be comprehensive.