• Journal of Biomedical Engineering Research
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• v.44 no.6
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• pp.414-427
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• 2023

Implantable bioabsorbable combination products undergo inherent degradation and systemic absorption within the physiological environment, thereby streamlining the therapeutic regimen and obviating the imperative for invasive extraction procedures. This inherent property not only enhances patient convenience and therapeutic efficacy but also underpins a paradigm of support characterized by heightened safety parameters. Within the regulatory landscapes of Korea, the United States, and Europe, implantable bioabsorbable combination products are meticulously classified into distinct categories, either as pharmaceutical implants or as implantable medical devices, depending on their primary mode of action. This scholarly investigation systematically examines the regulatory frameworks governing implantable bioabsorbable combination products in South Korea, the United States, and Europe. Notable discrepancies across national jurisdictions emerge concerning regulatory specifics, including terminology, product classification, and product name associated with these products. The conspicuous absence of standardized approval regulations presents a formidable barrier to the commercialization of these advanced medical devices. This academic discourse passionately emphasizes the critical need for formulating and implementing a sophisticated regulatory framework capable of streamlining the product approval process, thereby paving the way for a seamless path to commercializing implantable bioabsorbable combination products.

• Nuclear Engineering and Technology
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• v.51 no.2
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• pp.539-545
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• 2019

Yttrium-90 is a useful therapeutic radioisotope for tumor treatment because of its high-energy-emitting beta rays. However, it has been difficult to select appropriate collimators and main energy windows for Y-90 Bremsstrahlung imaging using gamma cameras because of the broad energy spectra of Y-90. We used a Monte Carlo simulation to investigate the effects of collimator selection and energy windows on Y-90 Bremsstrahlung imaging. We considered both MELP and HE collimators. Various phantoms were employed in the simulation to determine the main energy window using primary-to-scatter ratios (PSRs). Imaging performance was evaluated using spatial resolution indices, imaging counts, scatter fractions, and contrast-to-noise ratios. Collimator choice slightly affected energy spectrum shapes and improved PSRs. The HE collimator performed better than the MELP collimator on all imaging performance indices (except for imaging count). We observed minor differences in SR and SF values for the HE collimator among the five simulated energy windows. The combination of an HE collimator and improved-PSR energy window produced the best CNR value. In conclusion, appropriate collimator selection is an important component of Bremsstrahlung Y-90 photon imaging and main energy window determination. We found HE collimators to be more appropriate for improving the imaging performance of Bremsstrahlung Y-90 photons.

• 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.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.11-18
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• 2023

Currently, studies to predict the risk of rectal cancer surgery select MRI image slices based on the clinical experience of surgeons. The purpose of this study is to semi-automatically select and classify 2D MRI image slides to predict the risk of rectal cancer surgery using biomarkers. The data used were retrospectively collected MRI imaging data of 50 patients who underwent laparoscopic surgery for rectal cancer at Gachon University Gil Medical Center. Expert-selected MRI image slices and non-selected slices were screened and radiomics was used to extract a total of 102 features. A total of 16 approaches were used, combining 4 classifiers and 4 feature selection methods. The combination of Random Forest and Ridge performed with a sensitivity of 0.83, a specificity of 0.88, an accuracy of 0.85, and an AUC of 0.89±0.09. Differences between expert-selected MRI image slices and non-selected slices were analyzed by extracting the top five significant features. Selected quantitative features help expedite decision making and improve efficiency in studies to predict risk of rectal cancer surgery.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.25-32
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• 2023

Recognizing the size and location of prostate cancer is critical for prostate cancer diagnosis, treatment, and predicting prognosis. This paper proposes a model to classify the tumor region and normal tissue with cross-sectional visual images of prostatectomy tissue. We used specimen images of 44 prostate cancer patients who received prostatectomy at Gachon University Gil Hospital. A total of 289 prostate slice images consist of 200 slices including tumor region and 89 slices not including tumor region. Images were divided based on the presence or absence of tumor, and a total of 93 features from each slice image were extracted using Radiomics: 18 first order, 24 GLCM, 16 GLRLM, 16 GLSZM, 5 NGTDM, and 14 GLDM. We compared feature selection techniques such as LASSO, ANOVA, SFS, Ridge and RF, LR, SVM classifiers for the model's high performances. We evaluated the model's performance with AUC of the ROC curve. The results showed that the combination of feature selection techniques LASSO, Ridge, and classifier RF could be best with an AUC of 0.99±0.005.

• Journal of the Korean Institute of Illuminating and Electrical Installation Engineers
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• v.26 no.4
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• pp.1-5
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• 2012

By using LED optical devices and improving the efficiency of optical devices as well as lighting apparatus for humans, LED lighting industry puts the purpose of manufacturing the main products related with information, electric, large-sized LCD BLU, automobile, shipbuilding, agriculture, medical treatment, environment, and telecommunications, etc. Moreover, the main products and the industrial lighting products are manufactured with fusion, as the result, LED lighting industry provides various effects as well as sources of technology based on practical use of LED technology in order to develop the industry from the perspective of the lower price, the higher efficiency, the higher function, the deeper reliance. In the future, not only the development of new LED technology but also the fusion and combination of digital IT technologies using wire-wireless communication, sensor, controller, and artificial intelligence will be expected to create new industrial fields.

• Journal of Biomedical Engineering Research
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• v.33 no.3
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• pp.114-127
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• 2012

Recent technical advancement allows noninvasive measurement of blood glucose. In this literature, we reviewed various noninvasive techniques for measuring glucose concentration. Optical or electrical methods have been investigated. Optical techniques include near-infrared spectroscopy, Raman spectroscopy, optical coherence technique, polarization, fluorescence, occlusion spectroscopy, and photoacoustic spectroscopy. Electrical methods include reverse iontophoresis, impedance spectroscopy, and electromagnetic sensing. Ultrasound, detection from breath, or fluid harvesting technique can be used to measure blood glucose level. Combination of various methods is also promising. Although there are many interesting and promising technologies and devices, there need further researches until a commercially available non-invasive glucometer is popular.

• Archives of Plastic Surgery
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• v.47 no.5
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• pp.419-427
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• 2020

Background This study evaluated the Blossom system, an innovative self-filling, rate-controlled, pressure-responsive saline tissue expander (TE) system. We investigated the feasibility of utilizing this technology to facilitate implant-based and combined flap with implant-based breast reconstruction in comparison to conventional tissue expansion. Methods In this prospective, single-center, single-surgeon pilot study, participants underwent either implant-based breast reconstruction or a combination of autologous flap and implantbased breast reconstruction. Outcome measures included time to full expansion, complications, total expansion volume, and pain scores. Results Fourteen patients (TEs; n=22), were included in this study. The mean time to full expansion was 13.4 days (standard error of the mean [SEM], 1.3 days) in the combination group and 11.7 days (SEM, 1.4 days) in the implant group (P=0.78). The overall major complication rate was 4.5% (n=1). No statistically significant differences were found in the complication rate between the combination group and the implant group. The maximum patient-reported pain scores during the expansion process were low, but were significantly higher in the combination group (mean, 2.00±0.09) than in the implant group (mean, 0.29±0.25; P=0.005). Conclusions The reported average duration for conventional subcutaneous TE expansion is 79.4 days, but this pilot study using the Blossom system achieved an average expansion duration of less than 14 days in both groups. The Blossom system may accommodate single-stage breast reconstruction. The overall complication rate of this study was 4.5%, which is promising compared to the reported complication rates of two-stage breast reconstruction with TEs (20%-45%).

• Asia pacific journal of information systems
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• v.29 no.4
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• pp.817-837
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• 2019

The medical industry is rapidly evolving into a combination of artificial intelligence (AI) and ICT technology, such as mobile health, wireless medical, telemedicine and precision medical care. Medical artificial intelligence can be diagnosed and treated, and autonomous surgical robots can be operated. For smart medical services, data such as medical information and personal medical information are needed. AI is being developed to integrate with companies such as Google, Facebook, IBM and others in the health care field. Telemedicine services are also becoming available. However, security issues of medical information for smart medical industry are becoming important. It can have a devastating impact on life through hacking of medical devices through vulnerable areas. Research on medical information is proceeding on the necessity of privacy and privacy protection. However, there is a lack of research on the practical measures for protecting medical information and the seriousness of security threats. Therefore, in this study, we want to confirm the research trend by collecting data related to medical information in recent 5 years. In this study, smart medical related papers from 2014 to 2018 were collected using smart medical topics, and the medical information papers were rearranged based on this. Research trend analysis uses topic modeling technique for topic information. The result constructs topic network based on relation of topics and grasps main trend through topic.

• Journal of rehabilitation welfare engineering & assistive technology
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• v.4 no.1
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• pp.1-8
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• 2010

The combination of medical devices and IT convergence technology has made it possible to check health whenever and wherever people want. The recent development of various Ubiqutous Healthcare medical devices ensures the convenient measurements of health variations in daily lives and at home. However, considering that there is a growing prevalence of the devices and a great interest in the development of Ubiqutous Healthcare device, it is urgent to secure the stability and to establish performance evaluation. Therefore, it is needed to develop standard testing methods for the stability and the performance evaluation on before and after selling products. In this paper, I studied the standard testing method of both compulsory tests and performance evaluation which are for the electric stability evaluation on Ubiqutous Healthcare devices.