TBS iNsight (Osteo)

Medimaps Group

TBS iNsight (Osteo) is a product by Medimaps Group that predicts a patient’s risk for bone fracture to aid therapy decision and patient management. TBS iNsight (Osteo) is aimed at the departments of endocrinology, radiology, orthopedics, rheumatology, gyanecology and nephrology.

Information source: Vendor
Last updated: September 28, 2023

General Information

General
Product name	TBS iNsight (Osteo)
Company	Medimaps Group
Subspeciality	MSK
Modality	X-ray
Disease targeted	Primary Osteoporosis, Secondary Osteoporosis
Key-features	Trabecular Bone Score (TBS) calculation, fracture risk assessment (BMD T-score & FRAX adjusted with TBS), editable report
Suggested use	Before: flagging acute findings During: perception aid (prompting all abnormalities/results/heatmaps), interactive decision support (shows abnormalities/results only on demand), report suggestion After: diagnosis verification

Technical Specifications

Data characteristics
Population	All DXA scans of post menopausal women and patients with secondary osteoporosis
Input	DXA 2-D images produced during a regular spine Bone Mineral Density (BMD) scan
Input format	DXA Vendor specific format
Output	Editable report with fracture risk score, table with quantified values
Output format	PDF report
Technology
Integration	Integration in standard reading environment (PACS), Stand-alone third party application
Deployment	Locally on dedicated hardware
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	< 3 sec

Regulatory

Certification
CE	Certified, Class IIa , MDR
FDA	510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE)

Market

Market presence
On market since	2012
Distribution channels
Countries present (clinical, non-research use)	>60
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model
Based on

Evidence

Evidence
Peer reviewed papers on performance	A Meta-Analysis of Trabecular Bone Score in Fracture Risk Prediction and Its Relationship to FRAX (read) Bone Microarchitecture Assessed by TBS Predicts Osteoporotic Fractures Independent of Bone Density: The Manitoba Study (read)
Non-peer reviewed papers on performance
Other relevant papers