• 제목/요약/키워드: New Medical Technology

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유럽의 새로운 의료기기 규제제도 MDR (New Medical Device Regulations (MDR) in Europe)

  • 정현우;염호준;박상수
    • 문화기술의 융합
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    • 제8권5호
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    • pp.29-37
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    • 2022
  • 2017년 새롭게 제정된 유럽의 새 의료기기 규제법인 MDR은 기존의 CE 적합성 인증을 받은 의료기기 제품들이 새로운 CE의 MDR규정에 맞춰 2024년 5월까지 인증을 받도록 요구하고 있다. 새로운 MDR 적합성 요구사항은 기존보다 강화된 의료기기 임상평가 및 임상 조사를 요구하며 또한 문서화된 시판후 임상 추적 자료의 제출을 요구한다. 한국의 의료기기 업체들도 새로운 MDR 요구사항을 맞춰 적합인정을 받아야 하나, 새로우 규정을 정확히 이해하지 못하여 산업계의 혼란은 계속 되고 있다. 본 연구에서는 한국과 미국의 의료기기 관련 규정을 알아보고, 또한유럽의 의료기기법인 MDR을 기존의 유럽 의료기기 지침인 MDD와 비교함으로써 유럽 의료기기법의 요구 사항들을 이해하는데 도움이 되고자 한다.

의료기기 발전과 신의료기술평가 규제혁신 (Advanced medical devices and regulatory innovations in new health technology assessments)

  • 이유경
    • 대한의사협회지
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    • 제61권12호
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    • pp.702-705
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    • 2018
  • Advances in technology lead to advances in medical devices, and these advances have the positive effect of creating opportunities for beneficial developments in healthcare, such as innovating traditional healthcare processes or expanding opportunities for diagnosing and treating diseases. Nonetheless, device developers, suppliers, users, insurers, and patients all face the challenge of balancing patient safety and health effectiveness with a reasonable profit. In Korea, the New Health Technology Assessment system aims to introduce safe and effective health technology, but this is only effective for the entry of devices onto the healthcare market. This system is not enough for creating a healthy ecosystem in which high-quality technologies and devices survive in the market and naturally exit from the market if not successful. The nation must not lag in the rapid development of medical devices, but the concomitant requirement for patient safety is like two rabbits moving in different directions. There is not enough time to resolve each source of uncertainty for both developers and users. The early adoption of health technologies, including medical devices, offers new opportunities for treatment and diagnosis, but also poses unexpected health risks. Thus, we need to design a plan to generate scientific evidence related to medical devices after they introduced into practice. Additionally, regarding the use of individual medical devices, we believe that the creation of a healthy ecosystem for medical devices by implementing medical device surveillance culture is a way to manage the opportunities and risks of the early introduction of innovative medical devices.

New Medical Image Fusion Approach with Coding Based on SCD in Wireless Sensor Network

  • Zhang, De-gan;Wang, Xiang;Song, Xiao-dong
    • Journal of Electrical Engineering and Technology
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    • 제10권6호
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    • pp.2384-2392
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    • 2015
  • The technical development and practical applications of big-data for health is one hot topic under the banner of big-data. Big-data medical image fusion is one of key problems. A new fusion approach with coding based on Spherical Coordinate Domain (SCD) in Wireless Sensor Network (WSN) for big-data medical image is proposed in this paper. In this approach, the three high-frequency coefficients in wavelet domain of medical image are pre-processed. This pre-processing strategy can reduce the redundant ratio of big-data medical image. Firstly, the high-frequency coefficients are transformed to the spherical coordinate domain to reduce the correlation in the same scale. Then, a multi-scale model product (MSMP) is used to control the shrinkage function so as to make the small wavelet coefficients and some noise removed. The high-frequency parts in spherical coordinate domain are coded by improved SPIHT algorithm. Finally, based on the multi-scale edge of medical image, it can be fused and reconstructed. Experimental results indicate the novel approach is effective and very useful for transmission of big-data medical image(especially, in the wireless environment).

추간판 내열 치료술(Intradiscal Electrothermal Therapy)의 사례를 통해 발견되는 척수 수술 영역 신의료기술의 임상 적용 과정의 문제에 관하여 (Regarding the Problem of Clinical Application of New Medical Technology in the Field of Spine Surgery Found through the Case of Intradiscal Electrothermal Therapy)

  • 홍영기
    • 한국콘텐츠학회논문지
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    • 제22권7호
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    • pp.652-662
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    • 2022
  • 현재 전 세계 의료계의 척추 수술 영역에선 다양한 신기술들이 빠르게 개발되어 임상에 적용되어 오고 있다. 논자는 이러한 신기술들이 환자에게 시술되기 전에 효능과 안전성에 대한 검토가 충실하게 이루어지고 있는지 논의해 볼 필요가 있다고 생각한다. 논자는 이 주제를 고찰하기 위해, 2000년대에 추간판성 통증 질환 치료의 신기술로 등장하여 현재까지 전 세계적으로 널리 시술되어오고 있는 추간판 내열 치료술의 기초 연구 자료들과 임상 적용 과정을 분석하였다. 그 결과 이 시술은 효능과 안전성에 관한 기반 연구가 불충분한 상태에서 임상 적용해 온 것으로 평가되었다. 논자는 이 사례가 현재 척추 수술 영역 신의료기술들의 임상 적용과 관련한 본질적 문제를 드러내고 있다고 판단한다. 따라서 논자는 척추 수술 영역의 신의료기술이 환자들에게 미칠 수 있는 부작용을 최소화하기 위해선 보다 충실한 수준의 기초 연구와 보다 높은 수준의 임상 허용기준이 갖추어져야 한다고 생각한다.

Proposed ICT-based New Normal Smart Care System Model to Close Health Gap for Older the Elderly

  • YOO, Chae-Hyun;SHIN, Seung-Jung
    • International journal of advanced smart convergence
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    • 제10권2호
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    • pp.37-44
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    • 2021
  • At the time of entering the super-aged society, the health problem of the elderly is becoming more prominent due to the rapid digital era caused by COVID-19, but the gap between welfare budgets and welfare benefits according to regional characteristics is still not narrowed and there is a significant difference in emergency medical access. In response, this study proposes an ICT-based New Normal Smart Care System (NNSCS) to bridge the gap I n health and medical problems. This is an integrated system model that links the elderly themselves to health care, self-diagnosis, disease prediction and prevention, and emergency medical services. The purpose is to apply location-based technology and motion recognition technology under smartphones and smartwatches (wearable) environments to detect health care and risks, predict and diagnose diseases using health and medical big data, and minimize treatment latency. Through the New Normal Smart Care System (NNSCS), which links health care, prevention, and rapid emergency treatment with easy and simple access to health care for the elderly, it aims to minimize health gaps and solve health problems for the elderly.

알루미늄계단을 이용한 X선필름의 감도측정법에 관한 새로운 시도 (A New Approach in Sensitometry of X-ray Film to Use Aluminium Stepwedge)

  • 허준;김창균;강홍석;이선숙
    • 대한방사선기술학회지:방사선기술과학
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    • 제6권1호
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    • pp.35-41
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    • 1983
  • Boot-Strap method is used to measure the sensitivity of X-ray film, but it is too complicated to design the plot and this method is generally a falling-off in the accuracy and the reproducibility. Authors made an attempt a new method to obtain the stable H-D curve, that is to say; Boot-Strap method used in combination with distance-change method, and the accuracy and the reproducibility.

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임상유전학 교육에서 새로운 교과과정 개발의 필요성 (The Need for a New Curriculum in Clinical Genetic Education)

  • 이창우
    • 의학교육논단
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    • 제16권1호
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    • pp.50-54
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    • 2014
  • It is becoming increasingly important for medical doctors to have a thorough understanding of human genetics and the ethical, legal, and social implications of genetic testing, counseling, and treatment. As genetic engineering and technology evolves, medical doctors will find themselves called in to counsel patients about a rapidly increasing number of diseases for which genetic testing and treatments are available. Medical doctors will need to master a new set of principles and clinical skills. A lack of knowledge about these issues and problems may lead to serious, lifelong or even fatal negative effects on patients. Medical genetics has moved from the study of rare conditions to the illumination of disorders that impact the entire spectrum of medical practice. This study demonstrates several areas in which medical genetics is clearly an important tool in medical practice and the necessity of establishing new curriculum for clinical genetic education in Korea. Medical students nearing graduation may lack genetic knowledge that is essential for daily practice because genetics has little or no place in clinical teaching. Medical schools should make extensive curriculum changes to increase students' awareness of clinical genetics and its ethical implications. The medical school curriculum will need creative new approaches to keeping up with the rapid pace of evolution of clinical genetics.

장기이식에 관한 한의학적 개념 연구 (Study on the Organ Transplantation in the Oriental Medicine)

  • 김경신;이수진;김병수
    • 동의생리병리학회지
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    • 제24권4호
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    • pp.571-579
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    • 2010
  • The advancement of medical technology has made it possible to treat various incurable diseases. Especially organ transplantation can give another life to the patients who have organ failure and could not find any other ways to treat their diseases. According to the development of medical technology and immunosuppressive drugs, the rate and extent of organ transplantation is increasing these days. New medical technologies like organ transplantation brought on critical issues and these have changed the way of thinking and morals that has been the fundamental rules in our society. Bioethics is already an important field of medicine and oriental medicine should investigate the problem caused by the development of medical technology and life science and should form a view of life in oriental medicine. Oriental medicine is East Asian traditional medicine based on "Huangdi-Neijing", constructed by the system of Jangfu and meridian. The traditional therapies of oriental medicine have completed a scientific system on the point of view that looks on human and nature equally. This process continued to form a new medical theory as the environment was changed and the new diseases were appeared since "Huangdi-Neijing" and "Shoganron" showed a new scope to investigate human and diseases. Therefore, it is important to develop the point of view of oriental medicine as the medical situation was changed. Oriental medicine has a holistic view that considers human as a little cosmos resonated by a big cosmos and regards the possibility to recover and to regulate the energy in our body. This theory is a basic idea of oriental philosophy. Oriental medicine focuses on the balance of yin and yang of the body and tries to harmonize the imbalance of yin and yang caused by the life style and environment. This can solve many problems that cannot be settled by modern medicine and this can accomplish the new paradigm of oriental medicine that is needed these days.

합리적 기술 활용이 연구개발에 미치는 영향: 의료기기 개발 사례를 중심으로 (The Impact of Technology Utilization on Health Research and Development: Case Studies of the Development of Medical Device)

  • 민혜숙;박지은;김창엽
    • 보건행정학회지
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    • 제31권2호
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    • pp.148-157
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    • 2021
  • Background: Based on that the key function of health technology is improving the quality of healthcare services, our study purports to explore the process of medical device development in detail and to discuss its policy implications. Methods: A total of 12 in-depth interviews were conducted with four groups of industry, hospital, academia, and civil society. All of the interviewees except those from civil society were involved in the new medical device development between 2009 and 2018. We performed a text network analysis and content analysis of the interview data. Results: The frequency and the degree centrality rankings suggested a close association between the utilization issue and the technology development. Similarly, the results of the content analysis showed that the appropriate intervention in the utilization of technology has a direct impact on the progress of development. Under the continuous industrial effort to boost profits by developing new technology, service providers and citizens should be knowledgeable of and make good use of the new technology for the provision of better services. Conclusion: As the development itself would not guarantee the improvement of service quality and better health outcomes, health technology policies should take a more comprehensive view to serve the unmet needs and even to facilitate the technology development.

CORRELATION SEARCH METHOD WITH THIRD-ORDER STATISTICS FOR COMPUTING VELOCITIES FROM MEDICAL IMAGES

  • 김대훈;;오명환
    • 대한의용생체공학회:학술대회논문집
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    • 대한의용생체공학회 1991년도 춘계학술대회
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    • pp.9-12
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    • 1991
  • The correlation search method yields velocity information by tracking scatter patterns between medical image frames. The displacement vector between a target region and the best correlated search region indicates the magnitude and direction of the inter-frame motion of that particular region. However, if the noise sources in the target region and the search region are correlated Gaussian, then the cross-correlation technique fails to work well because it estimates the cross-correlation of both signals and noises. In this paper we develop a new correlation search method which seeks the best correlated third-order statistics between a target and the search region to suppress the effect of correlated Gaussian noise sources. Our new method yields better estimations of velocity than the conventional cross-correlation method.

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