BoneView Trauma

GLEAMER
BoneView is an AI Companion for lesion detection on Bone X-Rays. BoneView can detect fractures, effusions, dislocations and bone lesions, and gives 3 different pre-diagnosis labels on the images:
- POSITIVE when the confidence for the presence of a lesion is above 90% (plain bounding box around the region of interest)
- DOUBT when the confidence for the presence of a lesion is between 50% and 90% (dotted bounding box around the region of interest)
- NEGATIVE otherwise

BoneView provides a Summary Table for quality check and overview of AI outputs at a glance, and can perform worklist prioritization according to the different pre-diagnoses.

*In the United States, BoneView Trauma is named BoneView and has been 510k FDA-cleared for pediatrics (limbs above 2yo).
Information source: Vendor
Last updated: Jan. 26, 2024

General Information

General
Product name BoneView Trauma
Company GLEAMER
Subspeciality MSK
Modality X-ray
Disease targeted Bone fractures, effusions, dislocations and bone lesions
Key-features Detection of fractures, effusions, dislocations and bone lesions, worklist prioritization
Suggested use Before: adapting worklist order, flagging acute findings
During: perception aid (prompting all abnormalities/results/heatmaps), interactive decision support (shows abnormalities/results only on demand)
After: diagnosis verification

Technical Specifications

Data characteristics
Population Adult and pediatric patients with suspicion of fracture
Input Bone trauma X-ray
Input format DICOM
Output Image annotation, pre-diagnosis
Output format DICOM
Technology
Integration Integration in standard reading environment (PACS), Integration RIS (Radiological Information System), Integration via AI marketplace or distribution platform
Deployment Locally on dedicated hardware, Locally virtualized (virtual machine, docker), Cloud-based
Trigger for analysis Automatically, right after the image acquisition
Processing time 1 - 10 minutes

Regulatory

Certification
CE
Certified, Class IIa , MDR
FDA 510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE) Provide preliminary data for helping physicians’ diagnosis of extremity X-rays

Market

Market presence
On market since 03-2020
Distribution channels Incepto, Softway, Fuji Reili, Ferrum Health, Wellbeing Software, Sectra Amplifier Store, Blackford, RMS Medical Devices, Aidoc aiOS, deepcOS, HCK Healthcare Konnect, Eureka Clinical AI
Countries present (clinical, non-research use) 22
Paying clinical customers (institutes) 420
Research/test users (institutes) 22
Pricing
Pricing model Subscription
Based on Number of users, Number of installations, Number of analyses

Evidence

Evidence
Peer reviewed papers on performance
Non-peer reviewed papers on performance
Other relevant papers