• Investigative Magnetic Resonance Imaging
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• v.25 no.4
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• pp.218-228
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• 2021

Due to their high degree of freedom to transfer and acquire light, fiber optics can be used in the presence of strong magnetic fields. Hence, optical sensing and imaging based on fiber optics can be integrated with magnetic resonance imaging (MRI) diagnostic systems to acquire valuable information on biological tissues and organs based on a magnetic field. In this article, we explored the combination of MRI and optical sensing/imaging techniques by classifying them into the following topics: 1) functional near-infrared spectroscopy with functional MRI for brain studies and brain disease diagnoses, 2) integration of fiber-optic molecular imaging and optogenetic stimulation with MRI, and 3) optical therapeutic applications with an MRI guidance system. Through these investigations, we believe that a combination of MRI and optical sensing/imaging techniques can be employed as both research methods for multidisciplinary studies and clinical diagnostic/therapeutic devices.

• The Journal of Korean Medicine
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• v.35 no.3
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• pp.103-115
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• 2014

Objectives: The purpose of this survey was to investigate the need for new medical devices based on opinions of members of the Korean medical society. Methods: We distributed two independent questionnaires sequentially over two-week intervals to 16,510 doctors via the Korean Medical Society, and received replies from 888 and 928 doctors, respectively. The survey was carried out through a web-based questionnaire system. The first questionnaire focused on demand for new diagnostic and therapeutic medical devices that are specific for Korean medicine (KM). In contrast, the second questionnaire focused on demand for new hybrid medical devices which are useful both in Western medicine (WM) and KM. Results: In purchase intention of Korean medical devices (KMDs), demand for diagnostic devices was greater than for therapeutic ones. Among diagnostic devices, the purchase intention of 'imaging devices' ranked the highest and was followed by 'musculoskeletal diagnostic devices'. Among therapeutic KMDs, the purchase intention of 'musculoskeletal treatment devices' ranked the highest, followed by 'cranial nerve rehabilitation devices'. In the purchase intention of hybrid medical devices that can be used both in WM and KM, 'ultrasonic-based medical device' ranked the highest, followed by 'MRI-based medical device'. Conclusions: There is increasing demand for clinically useful medical devices among Korean medical doctors. Within demand for new devices, hybrid devices that can be used in both WM and KM were most strongly desired. This survey will be useful in establishing strategic plans for the development of medical devices in KM. Keywords: Korean medicine, medical device, demand survey, questionnaire.

• Journal of Biomedical Engineering Research
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• v.42 no.3
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• pp.125-142
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• 2021

The POCT (point-of-care test) sensing that has been a fast-developing field is expected to be a next generation technology in health care. The POCT sensors for the detection of proteins, small molecules and especially nucleic acids have lately attracted considerable attention. According to the World Health Organization (WHO), the POCT methods are required to follow the ASSURED guidelines (Affordable, Sensitive, Specific, User- friendly, Robust and rapid, Equipment-free, Deliverable to all people who need the test). Recently, several CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) based diagnostic techniques using the sensitive gene recognition function of CRISPR have been reported. CRISPR/Cas (Cas, CRISPR associated protein) systems based detection technology is the most innovative gene analysis technology that is following the ASSURED guidelines. It is being re-emerged as a powerful diagnostic tool that can detect nucleic acids due to its characteristics that enable rapid, sensitive and specific analyses of nucleic acid. The first CRISPR-based diagnosis begins with the discovery of the additional function of Cas13a. The enzymatic cleavage occurs when the conjugate of Cas protein and CRISPR RNA (crRNA) detect a specific complementary sequence of the target sequence. Enzymatic cleavage occurs on not only the target sequence, but also all surrounding non-target single-stranded RNAs. This discovery was immediately utilized as a biosensor, and numerous sensor studies using CRISPR have been reported since then. In this review, the concept of CRISPR, the characteristics of the Cas protein required for CRISPR diagnosis, the current research trends of CRISPR diagnostic technology, and some aspects to be improved in the future are covered.

• Korean Journal of Radiology
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• v.22 no.3
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• pp.442-453
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• 2021

Artificial intelligence (AI) will likely affect various fields of medicine. This article aims to explain the fundamental principles of clinical validation, device approval, and insurance coverage decisions of AI algorithms for medical diagnosis and prediction. Discrimination accuracy of AI algorithms is often evaluated with the Dice similarity coefficient, sensitivity, specificity, and traditional or free-response receiver operating characteristic curves. Calibration accuracy should also be assessed, especially for algorithms that provide probabilities to users. As current AI algorithms have limited generalizability to real-world practice, clinical validation of AI should put it to proper external testing and assisting roles. External testing could adopt diagnostic case-control or diagnostic cohort designs. A diagnostic case-control study evaluates the technical validity/accuracy of AI while the latter tests the clinical validity/accuracy of AI in samples representing target patients in real-world clinical scenarios. Ultimate clinical validation of AI requires evaluations of its impact on patient outcomes, referred to as clinical utility, and for which randomized clinical trials are ideal. Device approval of AI is typically granted with proof of technical validity/accuracy and thus does not intend to directly indicate if AI is beneficial for patient care or if it improves patient outcomes. Neither can it categorically address the issue of limited generalizability of AI. After achieving device approval, it is up to medical professionals to determine if the approved AI algorithms are beneficial for real-world patient care. Insurance coverage decisions generally require a demonstration of clinical utility that the use of AI has improved patient outcomes.

• Journal of the Korean Society of Radiology
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• v.15 no.2
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• pp.159-164
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• 2021

The examination using diagnostic x-ray equipment is one of the most useful diagnostic equipment for identifying information in the human body in diagnostic radiology. For this reason, the number of examinations has recently increased a lot. Increasing the number of examinations will accelerate the aging of the device. In addition, this makes them aware of the importance of quality control for the diagnostic x-ray device. Particularly, in a diagnostic x-ray device, quality control refers to an act of always maintaining a certain level of image quality by identifying and correcting all problems that may lead to reduction of the diagnosis area in advance. Therefore, this study summarizes and reports general information about quality control in examinations using diagnostic x-ray equipment.

• Journal of The Korean Radiological Technologist Association
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• v.28 no.1
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• pp.120-144
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• 2002

Purpose The quality assurance in a computed tomography gives a definition to be all the activity so as to optimize the performance of the device and keep an invariable quality of image, and it is to raise a high diagnostic efficiency to obtain a much info

• Journal of Appropriate Technology
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• v.6 no.1
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• pp.45-50
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• 2020

We developed the world's first wireless ultrasound diagnostic device. For the smooth delivery of pregnant women, the WHO requires four prior examinations, and the use of ultrasound diagnostic devices is essential for this purpose. However, income levels and medical facilities in developing countries are falling short. We conducted KOICA's CTS program in Vietnam using a self-developed radio ultrasound diagnostic device. We supplied Sonon300C, a portable wireless ultrasound diagnostic device, to health centers and hospitals in Huong-Hoa district, Vietnam, and conducted an outreach program in an effort to further enhance business performance. As a result, the rate of ultrasound diagnostics in the region reached 100% and the percentage of trained graduates increased to 59%.

• The Journal of the Convergence on Culture Technology
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• v.8 no.5
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• pp.1-7
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• 2022

Korean medical device industry has laid the foundation for full-fledged growth and development with the G7 medical engineering technology development project that started in 1995, and the medical device production in 2020 increased by 8.52 times and the export by 13.94 times, compared to those in 2001. In early years, electronic medical devices such as ultrasound imaging device contributed greatly to Korean medical industry, but top ranks in medical device production and export in Korea has shifted recently to in vitro diagnostic medical devices and dental implants. However, the share of imported medical devices in the Korean medical device market have not changed much; it still ranges in 60 to 70%, as the Korean medical device industry produces and exports mid- to low-priced medical devices, and technology-intensive and capital-intensive high-priced medical devices are mainly imported. In this paper, we compare the leading medical devices produced by major Korean companies and those by global top medical device companies to suggest strategies for the Korean medical device companies to enter the global market.

• The Journal of Internal Korean Medicine
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• v.36 no.2
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• pp.85-92
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• 2015

Objectives: The liver fibroscan has been developed as a noninvasive and convenient method to assess hepatic fibrosis. This study aimed to review this device in terms of its technological concept and clinical application in traditional Korean medicine (TKM). Methods: The technological background, diagnostic evaluation, and clinical usefulness of fibroscan were reviewed using various literature and clinical studies. One clinical example-a patient with hepatofibrosis who had been treated with TKM-is presented. Results: The liver fibroscan was approved as a medical device for noninvasive measurement of the hepatic fibrosis level by the Korean Food and Drug Administration (KFDA). Numerous clinical studies have confirmed that its sensitivity and specificity allow it to serve as a substitute for liver biopsy, the present gold standard diagnostic method. The accuracy and reproducibility and lack of technical risks are strong points of the fibroscan; however, it has some limitations for application, especially in patients with obesity or severe hepatitis. One clinical example showed the applicability of the liver fibroscan in herbal medicine-based treatments. Conclusions: The requirement for diagnostic medical devices is an important issue in TKM; therefore, this study provides valuable information for practitioners of TKM.

• Journal of Biomedical Engineering Research
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• v.31 no.2
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• pp.123-128
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• 2010

The thermometers is widely used in diagnostic medical devices, and the safety and accurate performance of these devices are important in the diagnosis and monitoring of personal health. Especially, the accuracy of infra-red thermometer is highly emphasized. Here two typical thermometers are utilized for this purpose: the electronic thermometers measure body temperature by contacting to subject while infra-red thermometers measure by no contacting to subject. Therefore, the evaluating items of each thermometer are different, and the standard for each temperature is highly needed. But, there have been no international standards of each thermometer such as IEC. In this paper, we developed the standards of electronic and infra-red thermometer based on national standards such as KS, ASTM, EN, JIS and FDA guidance. The new standards focused on the safety and suitable performance for health care. This standards were applied to enact and revise the electronic medical device standards. So it can be applied to evaluate the safety and performance on technical file review. We predict that this standard will improve the quality of diagnostic medical devices (thermometers) and increase the international competitive power of domestic product.