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销售价格： ￥ N/A
商品编号： AI-134-1874
软件语言： 英文
器械分类： II
生产厂家： ImageBiopsy Lab
公司网址： https://www.imagebiopsy.com/
认证信息： FDA
系统要求： Windows
交付方式： 下载安装
  • 软件概览
  • 推荐配置
  • 典型病例
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软件概览

IB Lab FLAMINGO

Detection of vertebral Fractures in routine CT Scans as secondary radiological Findings


Problems

Vertebral compression fractures are predominantly triggered by minimal or low energy trauma and are often caused by osteoporosis. Currently, roughly 200 million people worldwide suffer from osteoporosis, with a higher prevalence in women (1 in 3) than in men (1 in 5) and increases with age. 

 A vertebral fracture has been shown to increase the risk of a major osteoporotic fracture by 72% compared to study subjects without vertebral fractures at baseline, and this increased fracture risk was most pronounced for the risk of a future hip fracture. Osteoporosis is a major concern in Europe as it results in 4.3 million fragility fractures and health care costs in excess of €56 billion annually.

Only 26% of vertebral fractures were correctly and accurately reported as an incidental finding.


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Solutions

IB Lab FLAMINGO provides opportunistic detection and classification of clinically relevant vertebral compression fractures (Genant grade 2 or 3) as secondary radiological findings in routine CT-scans.

Introducing a routine examination of bone health

..when the imaging is performed for another indication (opportunistic vertebral fracture assessment, incidental findings)

Standardized terminology

to describe the presence of vertebral fractures

AI-assistance

can be beneficial for radiology reporting

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Product description

IB Lab FLAMINGO serves as our AI solution designed to assist in the assessment of vertebral fractures within CT scans, which are obtained for diverse clinical purposes and encompass segments of the thoracic and/or lumbar spine. This tool aims to enhance the process of diagnosing patients with vertebral fractures for further treatment decisions.

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Findings:

Vertebral labeling of thoracic and lumbar spine

Subject-level: Vertebral fracture detection (absence/presence)

Vertebral-level: Vertebral fracture detection (absence/presence)

Graphical summary of findings


Intended use

IB Lab FLAMINGO is a fully-automated radiological image processing software device intended to aid users in the detection of vertebral fractures on computer tomography (CT) scans by providing: 

Vertebral labeling of fully visible thoracic and lumbar vertebrae

Presence/absence of vertebral fractures

It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The intended user of IB Lab FLAMINGO is a healthcare professional trained in radiology (including but not limited to radiologist, endocrinologist, rheumatologist, traumatologist, orthopedist). 

The usage of IB Lab FLAMINGO is limited to use in adults aged 50 years and older.

References

Delmas, P.D., van de Langerijt, L., Watts, N.B., Eastell, R., Genant, H., Grauer, A. and Cahall, D.L. (2005), Underdiagnosis of Vertebral Fractures Is a Worldwide Problem: The IMPACT Study. J Bone Miner Res, 20: 557-563. https://doi.org/10.1359/JBMR.041214

Gehlbach SH, Bigelow C, Heimisdottir M, May S, Walker M, Kirkwood JR. Recognition of vertebral fracture in a clinical setting. Osteoporos Int. 2000;11(7):577-82. doi: 10.1007/s001980070078. PMID: 11069191.

Majumdar SR, Kim N, Colman I, et al. Incidental Vertebral Fractures Discovered With Chest Radiography in the Emergency Department: Prevalence, Recognition, and Osteoporosis Management in a Cohort of Elderly Patients. Arch Intern Med. 2005;165(8):905–909. doi:10.1001/archinte.165.8.905

Hans Peter Dimai, New Horizons: Artificial Intelligence Tools for Managing Osteoporosis, The Journal of Clinical Endocrinology & Metabolism, Volume 108, Issue 4, 1 April 2023, Pages 775–783, https://doi.org/10.1210/clinem/dgac702

Nicolaes J, Liu Y, Zhao Y, Huang P, Wang L, Yu A, Dunkel J, Libanati C, Cheng X. External validation of a convolutional neural network algorithm for opportunistically detecting vertebral fractures in routine CT scans. Osteoporos Int. 2023 Sep 7. doi: 10.1007/s00198-023-06903-7. Epub ahead of print. PMID: 37674097.

Skjødt MK, Nicolaes J, Smith CD, Olsen KR, Cooper C, Libanati C, Abrahamsen B. Fracture Risk in Men and Women With Vertebral Fractures Identified Opportunistically on Routine Computed Tomography Scans and Not Treated for Osteoporosis: An Observational Cohort Study. JBMR Plus. 2023 Mar 15;7(5):e10736. doi: 10.1002/jbm4.10736. PMID: 37197322; PMCID: PMC10184021.

D. C. Howlett, K. J. Drinkwater, N. Mahmood, J. Illes, J. Griffin, and K. Javaid, “Radiology reporting of osteoporotic vertebral fragility fractures on computed tomography studies: results of a UK national audit,” Eur. Radiol., vol. 30, no. 9, pp. 4713–4723, Sep. 2020, doi: 10.1007/s00330-020-06845-2.

R. M. Mitchell, P. Jewell, M. K. Javaid, D. McKean, and S. J. Ostlere, “Reporting of vertebral fragility fractures: can radiologists help reduce the number of hip fractures?,” Arch. Osteoporos., vol. 12, no. 1, p. 71, Dec. 2017, doi: 10.1007/s11657-017-0363-y.


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