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Medicare’s Reimbursement for Innovative Technologies: Focusing on Artificial Intelligence Medical Devices

Lee B, Yim J, Yang J

The costliness index (CI) is an index that is used in various ways to improve the quality of medical care and the management of appropriate treatment in medical institutions. However,...
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Comparison of Postmarket Surveillance Strategies of Implantable Medical Devices in the United States, European Union, and South Korea

Cho Yo, Lee JYe, Shim DaYo, Park SJ, Rhee HE, Sung HG, Kim HJ, Choi NK, Song HJ, K im JA, Park Sm, Shin JY

The biomedical industry is making rapid progresses like never before, and the number of adverse events caused by implantable medical devices is also increasing. As such, there is an ever-growing...
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Application of GLP in identification and quantification of degradation products from bone graft materials

Seo YB, Kim KH, Sim WJ, Kwon JS

Biocompatibility testing of bone graft materials are important aspect for development of the device as well as the approval and certification by each individual country’s regulatory authority. Recently, importance in...
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Application of digital software as a medical devices in dental clinic

Woo K, Baik S, Kim ST

By facing the era of the 4th industrial revolution, personalized medical services for patients are expanding with the development of information and communications technology. With these changes, digital medical devices...
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Performance of the MP570T pulse oximeter in volunteers participating in the controlled desaturation study: a comparison of seven probes

Choi BM, Kang BJ, Yun HY, Jeon B, Bang JY, Noh GJ

Background: The performance of the pulse oximeter was evaluated based on the ISO 80601-2-61:2011 (E) guidelines. This study aimed to determine whether the various finger probes of the MP570T pulse...
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Medical Devices of the Abdomen and Pelvis and Their Complications: A Radiologic Atlas

Jeong Y, Lee J, Kim KA, Park CM

A variety of medical devices have evolved throughout the years. Commonly used devices have typical radiological appearances which are familiar to radiologists. However, some new devices, as well as devices...
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‘Radial force’ of colonic stents: A parameter without consistency, definition or standard

Laasch HU, Milward GD, Edwards DW

Background: To investigate the expansion force of current colonic stents and to match these to industry standards. Methods: Samples of all colonic stents were requested from manufactures world-wide. Expansion forces were...
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A Prospective, Randomized, Controlled Comparative Study of Three Energy Devices in Open Thyroid Surgery: Thunderbeat, Harmonic, and Ligasure

Back K, Hur N, Kim MJ, Choe JH, Kim JH, Kim JS

PURPOSE: Energy devices, such as Harmonic Focus Plus (Ethicon; ultrasonic scalpel; Harmonic) and Ligasure Small Jaw (Covidien; bipolar sealer; Ligasure) are widely used in thyroid surgery as substitutes for Bovie...
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Differences in Perspectives of Medical Device Adverse Events: Observational Results in Training Program Using Virtual Cases

Yoon C, Nam KC, Lee YK, Kang Y, Choi SJ, Shin HM, Jang H, Kim JK, Kwon BS, Ishikawa H, Woo E

BACKGROUND: Medical device adverse event reporting is an essential activity for mitigating device-related risks. Reporting of adverse events can be done by anyone like healthcare workers, patients, and others. However,...
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Swallowing Function Following Anterior Cervical Discectomy and Fusion with and Without Anterior Plating: a SWAL-QOL (Swallowing-Quality of Life) and Radiographic Assessment

Haws BE, Khechen B, Patel DV, Yoo JS, Guntin JA, Cardinal K, Singh K

OBJECTIVE: Anterior cervical plating in anterior cervical discectomy and fusion (ACDF) procedures are associated with improved outcomes compared to stand-alone cages. However, concerns exist regarding increased rates of postoperative dysphagia...
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Characteristics Influencing the Occurrence of Respiratory Medical Device-related Pressure Ulcers in the Pediatric Intensive Care Unit

Kim HK, Kim Y, Son HM

PURPOSE: This prospective study was conducted to determine the incidence and related characteristics of respiratory medical device-related pressure ulcers (MDRPU) in children admitted to a pediatric intensive care unit (PICU). METHODS:...
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Advanced medical devices and regulatory innovations in new health technology assessments

Lee YK

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...
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Evaluation of Clinical Alarms and Alarm Management in Intensive Care Units

Jeong YJ, Kim H

PURPOSE: This study aimed to investigate the clinical alarm occurrence and management of nurses toward clinical alarms in the intensive care unit (ICU). METHODS: This observational study was conducted with 40...
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Innovative Distribution Priorities for the Medical Devices Industry in the Fourth Industrial Revolution

Lee M, Yoon Y, Ryu GH, Bok HS, Yoon K, Park S, Lee KS

PURPOSE: This study aimed to set priorities for improving the medical device distribution structure and to suggest an innovative improvement plan for the distribution structure using the analytic hierarchy process...
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What Is the Future of Impedance Planimetry in Gastroenterology?

Gregersen , Lo KM

  • KMID: 2413094
  • J Neurogastroenterol Motil.
  • 2018 Apr;24(2):166-181.
  • doi: 10.5056/jnm18013
The gastrointestinal (GI) tract is efficient in transporting ingested material to the site of delivery in healthy subjects. A fine balance exists between peristaltic forces, the mixing and delivery of...
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Errors in Case No. 2012Hun-Ma551·561 relating to the use of modern medical devices by oriental medical doctors

You H

Our country has a dual medical system and as the importance of medical devices in medical practice has grown, oriental medical doctors have sought to use modern medical devices to...
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Accuracy of Capillary Blood Glucose Test When Fasting in Diabetes Patients or General Population: Performance Evaluation of G300 Based on ISO 15197:2013 Standards

Jee YM, Seo MH, Yoo BW, Hong SH, Cho CY, Cho YJ, Oh JE, Shin KS

BACKGROUND: Self-monitoring of blood glucose plays an important role in management of diabetes mellitus. Blood glucose measurement is based on using plasma glucose separated from whole blood, but many people...
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Outcomes Associated with the Off-label Use of Medical Devices in Congenital Heart Disease at a Single Institute

Kong YH, Song J, Huh J, Kang IS

BACKGROUND AND OBJECTIVES: While the off-label use of implantable medical devices for treating congenital heart disease is not uncommon, the present conditions and outcomes of their off-label use have rarely...
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Review of regulatory management on standards and specifications for veterinary medical devices in Korea

Kang KM, Kim TW, Kwon OR, Park HJ, Cho SM, Kim CH, Lee MH, Moon JS

Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications...
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Quantitative Computed Tomographic Volumetry after Treatment of a Giant Intracranial Aneurysm with a Pipeline Embolization Device

Lee WJ, Byun JS, Kim JK, Nam TK

Recently developed flow diverters, such as the pipeline embolization device (PED), allow for safe and efficacious treatment of giant intracranial aneurysms, with high occlusion rates and a low incidence of...
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