IB Lab LAMA
ImageBiopsy Lab
Information source:
Vendor
Last updated: July 14, 2024 |
General Information
General | |
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Product name | IB Lab LAMA |
Company | ImageBiopsy Lab |
Subspeciality | MSK |
Modality | X-ray |
Disease targeted | Genu varum, genu valgum, lower extremity length discrepancy |
Key-features | 12 radiological findings and measurements: genu varum, genu valgum, lower extremity length discrepancy, anatomical angles according to Paley, mechanical angles according to Paley, mechanical axis deviation (MAD), hip knee angle, joint line convergence angle, femur length, tibia length, AMA angle |
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 | |
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Population | Adult humans with suspected deformities of the lower extremities among them functional limitations, bio-mechanical and cosmetic indications |
Input | 2D radiograph |
Input format | DICOM |
Output | overlay, visual output report, text report in RIS (RIS-templates can be pre-defined) |
Output format | DICOM Secondary Capture, pdf, structured report |
Technology | |
Integration | Integration in standard reading environment (PACS), Integration RIS (Radiological Information System), Integration CIS (Clinical Information System), Integration via AI marketplace or distribution platform, Stand-alone third party application, Stand-alone webbased |
Deployment | Locally on dedicated hardware, Locally virtualized (virtual machine, docker), Cloud-based, Hybrid solution |
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 | 1 - 10 minutes |
Regulatory
Certification | |
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CE |
Certified,
Class I
, MDD
|
FDA | 510(k) cleared , Class II |
Intended Use Statements | |
Intended use (according to CE) | IB Lab LAMA is a radiological fully-automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of lower limbgeometry, assessment of leg alignment and leg length difference. The system is to be used by trained medical professionals including, but not limited to, orthopedists and radiologists. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. |
Market
Market presence | |
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On market since | 10-2020 |
Distribution channels | GE Healthcare, Siemens, Philips Healthcare, Nuance PIN, Ambra Health, Visus, Incepto, CARPL.ai, Osimis, Eureka Clinical AI |
Countries present (clinical, non-research use) | 5 |
Paying clinical customers (institutes) | |
Research/test users (institutes) | |
Pricing | |
Pricing model | Pay-per-use |
Based on | Number of analyses |
Evidence
Evidence | |
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Peer reviewed papers on performance |
|
Non-peer reviewed papers on performance | |
Other relevant papers |
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