• Investigative Magnetic Resonance Imaging
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• 제25권4호
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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.

• 대한한의학회지
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• 제35권3호
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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.

• 대한의용생체공학회:의공학회지
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• 제42권3호
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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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• 제22권3호
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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.

• 한국방사선학회논문지
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• 제15권2호
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• pp.159-164
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• 2021

진단용방사선발생장치를 이용한 검사는 영상의학과에서 인체 내 정보를 파악하기 위한 가장 유용한 진단장비 중 하나로 신뢰도가 매우 높다. 이와 같은 이유로, 최근에는 영상의학과 영역의 진단 검사 장비를 이용한 검사 건수가 매년 증가하고 있다. 또한, 검사 건수 증가는 장치의 빠른 노화를 불러일으키고 이로 인해 장치에 대한 정도관리(quality control, QC)의 중요성이 대두된다. 특히, 진단용방사선발생장치를 이용한 검사에서 정도관리란 검사시작부터 검사가 끝날 때 까지 발생할 수 있는 모든 문제점을 사전에 알아내고 대처하여 신뢰가 확보된 영상을 획득하여 제공하는 과정에 있는 일련의 모든 활동을 의미한다. 이에 본 연구에서는 진단용방사선발생장치를 이용한 검사에서 정도관리에 대해보고 한다.

• 대한방사선협회지
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• 제28권1호
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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

• 적정기술학회지
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• 제6권1호
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• pp.45-50
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• 2020

우리는 전세계 최초로 무선 초음파 진단기를 개발하였다. 임산부의 원활한 출산을 위해 WHO에서는 4번의 사전 진찰을 받도록 하고 있으며, 이를 위해 초음파 진단기의 사용이 필수적이다. 하지만, 개발도상국의 소득수준과 의료시설은 이에 미치지 못하고 있다. 우리는 자체개발한 무선 초음파 진단기를 이용해 KOICA의 CTS 프로그램을 베트남에서 진행하였다. 우리는 베트남 흥화현 내 보건소 및 병원에 휴대용 무선 초음파 진단기인 Sonon300C를 보급하였고, 사업성과를 더욱 높이기 위한 노력으로 진단 교육과 실습을 병행하고 아웃리치(Outreach) 프로그램을 실시하였다. 그 결과, 해당 지역의 초음파 진단기 보급률은 100%를 달성하였고, 교육 수료인원 비율은 59%까지 끌어올리는 성과를 얻었다.

• 문화기술의 융합
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• 제8권5호
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• pp.1-7
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• 2022

한국의 의료기기 산업은 1995년부터 시작된 G7 의료공학기술개발사업으로 본격적인 성장과 발전의 기틀을 마련하였으며 2020년 한국 의료기기 생산실적은 2001년에 비하여 8.52배, 수출 실적은 13.94배 성장하였다. 의료기기 국산화 개발 초기에 초음파 의료기기 등 전자 의료기기의 개발이 활발하였던 것과 비교하여 2020년에는 체외진단시약과 치과용 임플랜트의 생산 및 수출 실적이 상위권을 차지하고 있다. 그러나 한국 의료기기 시장에서 수입 의료기기가 차지하는 비중은 60-70%에서 큰 변화가 없는데 이는 한국의 의료기기 산업이 중저가 의료기기를 생산 수출하고, 기술집약적이고 자본집약적인 고가 의료기기는 주로 수입에 의존하고 있기 때문이다. 본 논문에서는 한국과 세계시장의 주요 의료기기 회사들의 생산 품목을 비교하여 한국 의료기기 산업의 세계 시장 진출에 대한 전략을 제시하고자 한다.

• 대한한방내과학회지
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• 제36권2호
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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.

• 대한의용생체공학회:의공학회지
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• 제31권2호
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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.