Overview
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ABSTRACT
The aim of this article is to assist the engineer or researcher in their development of image processing technologies in medical imaging. It provides the context, challenges and methods which apply to this discipline, regardless of any technological choice. Concrete aspects and elements of reflection are proposed in order to constitute an operational tool. Finally, this article focuses on risks and regulatory aspects which must be complied with in this domain.
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Frédéric BANEGAS: Director of Operations - Doctor, Intrasense SA, Montpellier, France
INTRODUCTION
Medical imaging covers the acquisition and reproduction of images of the human body based on various physical phenomena such as X-ray absorption, nuclear magnetic resonance, ultrasound wave reflection, radioactivity or, more simply, optical imaging.
It has revolutionized medicine by enabling non-invasive, dynamic visualization of the anatomy, physiology and metabolism of the human body for diagnostic purposes. This indirect visualization requires the use of image processing techniques to detect, quantify, characterize or filter the digital data acquired.
Successfully implementing these techniques is a highly collaborative and often translational engineering task, all within the critical context of preserving patient safety.
Over and above image processing techniques and methods, this article will attempt to provide some methodological elements to help such work achieve its objective, in an industrial or research context.
Our aim is to provide engineers, researchers and technical supervisors with concrete information, such as steps, tools and simple questions to ask. Bibliographical references will enable you to delve deeper into more fundamental or general aspects. Finally, the notions of context and purpose will be analyzed in particular, to give the project manager a sense of perspective and enable him or her to adjust efforts to the intended target.
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KEYWORDS
practical applications | Software development | prototyping | Computer | medicine | radiology | Medical Imaging | Image Processing
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Software development in medical image processing
Bibliography
Websites
Barton F. Branstetter IV, MD Basics of Imaging Informatics: Part 1 & Part 2 https://pubmed.ncbi.nlm.nih.gov/17431128/ and https://pubmed.ncbi.nlm.nih.gov/17581896/ (pages accessed 1 er ...
Standards and norms
- ISO Medical device software – Software lifecycle processes - IEC 62304 - 2006
- ISO Medical devices – Applying risk management to medical devices - EN ISO 14971 - 2012
Regulations
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12 July 1993, p. 1)Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices.
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The Ultimate Scientific and Technical Reference