• KIEE International Transactions on Electrophysics and Applications
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• v.5C no.1
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• pp.33-38
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• 2005

Recently, lasers have become widely used throughout the medical treatment field. Several types of lasers have been used for the purpose of hair removal since the Alexandrite laser was approved by the FDA (Food & Drug Administration) for clinical epilation. In this study, a long-pulsed Alexandrite laser system for hair removal adopting a multi-discharge method in which three flash lamps are turned on consecutively was designed and fabricated. This laser system shows the technology that makes it possible to create extended pulse by turning on three flash lamps consecutively. With this technique, the pulse width can be varied from 4ms∼10ms. Then using this Alexandrite laser system with the pulse width 10ms and the beam size 7mm, hair removal was performed on the back portion of a human hand and leg. This study shows that treatment by the long-pulsed Alexandrite laser produces hair removal with no relevant side effects.

• Proceedings of the KAIS Fall Conference
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• 2007.05a
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• pp.168-171
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• 2007

향후, 유비쿼터스 환경에서의 무선 인터넷 서비스는 FDA 단말기를 이용하여 언제, 어디서나 업무처리가 가능하게 되고, 사용자들은 어느 장소에서나 최신의 정보 서비스를 제공받을 수 있는 편리한 시대를 실현시켜 줄 것이다. 본 논문에서는 현행 주정차 단속의 문제점을 보완하기 위해 PDA를 이용하여 원활한 주정차 단속업무를 실현하기 위한 소프트웨어를 다루고 있다. 이를 위하여, 먼저 주정차 단속을 위한 업무흐름을 분석하고, 이를 지원하고 위한 워크플로우 엔진의 설계 및 응용의 구현을 목표로 하여 추진되었다. 중요한 논문의 내용으로는 시스템 시나리오의 분석 및 소프트웨어의 구조 및 모듈설계, 그리고 구현환경 및 구현결과에 대한 내용을 다루고 있다.

• Journal of The Korean Society of Agricultural Engineers
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• v.49 no.4
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• pp.23-31
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• 2007

The objective of the study is to prepare input data for FIA (Flood Inundation Analysis) & FDA (Flood Damage Assessment) through rainfall-runoff simulation by HEC-HMS model. For HwaOng watershed (235.6 $km^{2}$), HEC-HMS was calibrated using 6 storm events. Geospatial data processors, HEC-GeoHMS is used for HEC-HMS basin input data. The parameters of rainfall loss rate and unit hydrograph are optimized from the observed data. HEC-HMS was applied to simulate rainfall-runoff relation to frequency storm at the HwaOng watershed. The results will be used for mitigating and predicting the flood damage after river routing and inundation propagation analysis through various flood scenarios.

• Proceedings of the Korea Information Processing Society Conference
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• 2003.11c
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• pp.2005-2008
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• 2003

본 논문에서는 생체의 특징을 이용해 신분을 증명 또는 인증하는 생체인식 기술 중 지문이나 장문, 정맥, 홍채를 이용한 인식과 같이 장비에 접촉해야만 인증이 이루어지는 것과 달리 거부감이 없고, 별도의 전문 장비를 필요로 하지 않아 일반 대중들에 쉽게 접근할 수 있는 얼굴인식을 인터넷에 적용한 원격 신분증명 및 인증 시스템을 제안한다. 얼굴인식 알고리즘은 얼굴 특징을 분석하는 방식에 따라 PCA (Principal Component Analysis), ICA (Independent Component Analysis), FDA (Fisher Discriminant Analysis) 등이 발표되어 있다. 이들 알고리즘을 이용해 얼굴 특징을 분석한 결과를 원격지에 신속하고 정확하게 송수신할 수 있는 시스템이 요구됨에 따라 생체인식 시스템의 비교 평가와 함께 인터넷 상에서 얼굴인식을 이용한 원격 얼굴인식 시스템의 구성을 제안한다.

• Journal of Dental Anesthesia and Pain Medicine
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• v.23 no.5
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• pp.287-291
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• 2023

Sugammadex has shown faster reversal of steroidal neuromuscular blockade (NMB) than neostigmine, a traditional reversal agent for NMB, even in the intense block phase. This efficiency is possible because of the unique mechanism of action by encapsulating the NMB molecules. Therefore, with the use of sugammadex, we can also expect to avoid direct interactions with the cholinergic system and its subsequent side effects, which are disadvantages of traditional drugs. However, despite these benefits and US Food and Drug Administration (FDA) approval in 2015, rare adverse events associated with sugammadex have been reported. Herein, we report a case of bronchospasm that developed immediately after sugammadex administration.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.209-244
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• 2020

TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.

• The Journal of the Korea Contents Association
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• v.19 no.3
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• pp.365-374
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• 2019

Unlike benign tumors, malignant tumors are capable of metastasis, easy to relapse, poor survival, and low quality of life. In Korea, here is a tendency to treat the tumors collectively according to the General Principles of Cancer Chemotherapy(GPCC) of the Health Insurance Review & Assessment Service (HIRA). But recently, companion diagnostics(CDx) is recommended rather than unilateral medication because biomarker-based molecular diagnostics is possible to predict the drug response of patients before drug treatment. Not only domestic but also overseas Food and Drug Administratio (FDA) recommends the development of the CDx system at the stage of drug development to ensure the responsiveness and safety of medicines. In this study, I focused on the necessity of CDx development direction as well as CDx development status through literature review. Furthermore I also discussed CDx types according to the molecular diagnostic technology such as immunohistochemistry (IHC), polymerase chain reaction (PCR), in situ hybridization (ISH), and next-generation sequencing (NGS) not only in the approved CDx but also in the developing one by US FDA. And I suggested the technology issue of CDx development process such as a selection of molecular diagnostics at the time of release, a clear understanding of the CDx mechanism, and a convergence of drug with CDx development. The necessity of social insurance system also was proposed for CDx development.

• Biomolecules & Therapeutics
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• v.8 no.3
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• pp.269-275
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• 2000

Silibinin(silybin) is the active component of silymarin from Silybum marianum and has hepato-protective effect. It is water-insoluble and has low bioavailability. To improve its bioavailability, self-micro-emulsifying drug delivery system (SMEDDS) has been developed by Hanmi Pharmaceutical Company (Silyma $n^{R}$ 140 soft capsule). In this study, the pharmacokinetic profiles of Silyma $n^{R}$ were examined and compared it with a reference preparation, L Caps140 of B Pharmaceutical Company. This study was approved by Yonsei University Severance Hospital IRB(approval No. CR0004) and followed the bioequivalence test guideline of Korean FDA. Eighteen healthy adult volunteers were allocated based on 2$\times$2 Latin square cross-over design. They were given 2 capsules (each contains silymarin 140 mg (60 mg as silibinin)) of either drug at each period and crossed over after a week of drug-free washout period. Blood concentration of silibinin was measured by HPLC. The $C_{max}$ and AUC of the Silyma $n^{R}$ were 1542.0 $\pm$ 402.7 ng/ml and 3323.3 $\pm$ 824.7 ng.h/ml, respectively, and were significantly higher than those of reference preparation. The Tmax was 0.8 $\pm$ 0.3 h and significantly shorter than reference preparation. The $K_{e}$ and $T_{1}$2/ of both drugs were comparable. Percent differences in means against reference preparation were +88.3% for AUC, +222.6% for $C_{max}$, and -61.1% for $T_{max}$./.>././.>./.

• Journal of Veterinary Clinics
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• v.35 no.1
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• pp.1-6
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• 2018

This study reviewed the regulatory safety management system for prevention of side effects of veterinary medical devices in Korea based on data obtained through analyses of those medical devices. In order to ensure the safety of medical devices, Ministry of Food and Drug Safety has established the management system include licensing, test inspection (134 designated clinical trial agencies) and post management. In addition, it was introduce the good manufacture practice (GMP) certification system and device tracking requirements. In contrast, it is necessary to establish regulations for side effects report and awareness on veterinary medical devices in Korea. The center for veterinary medicine of FDA in the United States has been operated side effects reporting system of veterinary medical devices from user, manufactures and distributor. Due to increase the use of various kinds of veterinary medical devices for animals, it should be required to improve regulation related to the licensing procedures, GMP system, and the side effects reporting system in our country.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.41-52
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• 2023

With the international change in the medical device market owing to the development of innovative medical engineering and the use of various raw materials, a systematic and rational medical device classification system is needed to safely manage newly developed medical devices. This study aims to improve the domestic medical device classification system by proposing product establishment and segmentation. It is based on medical device products from the United States and Europe that are only available in foreign systems and are more subdivided than domestic products. This study analyzes and compares the domestic and foreign medical device classification systems by examining laws, guidelines, and analysis reports in Korea, the United States, and Europe. In accordance with product establishment and segmentation criteria, products subject to improvement are presented. This study contributes to safely managing medical devices that do not fit with the current classification system and to solving the confusion caused by the lack of international harmony in product classification systems.