4 results match your criteria: "Medical Device Clinical Research[Affiliation]"
BMC Health Serv Res
November 2024
ECRI Institute, E-03-10, Sunway Geo Avenue, Jalan Lagoon Selatan, Bandar Sunway, 47500, Subang Jaya, Selangor, Malaysia.
Background: The reporting of adverse events in medical devices (MD) is a starting point of post-market surveillance and the most common source of initial safety signals. Because MD adverse events (AE) occur globally and involve high-profile international public health crises, international regulators implanted standard codes for MDAE reporting. This study aimed to assess the application of MDAE terminology and codes by providing examples of virtual events.
View Article and Find Full Text PDFJ Korean Med Sci
October 2024
Research Center, Korean Academy of Medical Sciences (KAMS), Seoul, Korea.
Background: A clear and precise definition of the "intended use" in developing new medical devices can determine the success of entering the healthcare market. For this, practical collaboration between the clinical and engineering experts is necessary, and an appropriate tool is required for effective information collection and decision-making in the process.
Methods: The Korean Academy of Medical Sciences, in cooperation with the Korean Medical Device Development Fund, implemented the Healthcare Experts' Advisory Unit and Support (HAUS) program to match advisory clinical experts in medical device development projects.
Acta Med Philipp
May 2024
Medical Device Clinical Research, Safety and Medical Affairs Department, Clinchoice, Inc., Fort Washington, Pennsylvania, USA.
Background And Objectives: Type 2 diabetes mellitus (T2DM) is a global health concern affecting more than 400 million people worldwide. Diabetic neuropathy, nephropathy, retinopathy, and cardiovascular complications lead to debilitating effects to patients. To prevent these, the treatment goal is to lower the blood sugar levels and maintain at a normal range which is achieved through conventional treatments like insulin and oral hypoglycemic agents.
View Article and Find Full Text PDFPlast Surg Nurs
September 2017
Kathy Kelley, RN, BSN, is Senior Director of Clinical Affairs at AirXpanders and has more than 20 years of experience in hospital clinical, quality, and risk management, including more than 10 years of experience in medical device clinical research and medical quality analysis. Kathy received her Bachelor of Science in Nursing from Boston University. Jennie Kim, MHS, is Senior Director of Global Marketing at AirXpanders and has more than 15 years of experience in healthcare marketing and public relations including extensive experience in medical device marketing targeting healthcare professionals and consumers. Jennie received her Masters of Health Sciences degree from the Johns Hopkins University School of Public Health and her Bachelor of Arts degree from Pomona College.
The tissue expansion process using traditional saline expanders is lengthy and uncomfortable. A new technology has been developed, providing a needle-free option implanted after a mastectomy, and is activated by a handheld remote control releasing small amounts (10 cc) of carbon dioxide from an internal reservoir. The expander is gradually filled with CO2 resulting in mechanical stretching of the overlying tissue.
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