Results 11 to 20 of about 454,812 (304)

Medical device regulation: time to improve performance. [PDF]

PLoS Medicine, 2012
Sanket S Dhruva, Rita F Redberg
doaj   +2 more sources

Cardiac macrophages prevent sudden death during heart stress

Nature Communications, 2021
Cardiac immune cells play various roles in the maintenance of homeostasis and diseases in the heart. Here the authors show that cardiac resident macrophages are a critical regulator of cardiac impulse conduction through amphiregulin production ...
Junichi Sugita, Katsuhito Fujiu, Yukiteru Nakayama, Takumi Matsubara, Jun Matsuda, Tsukasa Oshima, Yuxiang Liu, Yujin Maru, Eriko Hasumi, Toshiya Kojima, Hiroshi Seno, Keisuke Asano, Ayumu Ishijima, Naoki Tomii, Masatoshi Yamazaki, Fujimi Kudo, Ichiro Sakuma, Ryozo Nagai, Ichiro Manabe, Issei Komuro   +19 more
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Reflection of the Medical Device Regulation

Current Directions in Biomedical Engineering, 2023
The MDR states the objectives of the law in the preface. There you will find, among other things, a consideration of small and medium-sized enterprises as well as high health protection and an innovative effect.
Sojka Karolina, Sohrabi Keywan, Gross Volker, Scholtes Michael   +3 more
doaj   +1 more source

Medical Device Regulation Efforts for mHealth Apps during the COVID-19 Pandemic—An Experience Report of Corona Check and Corona Health

J, 2021
Within the healthcare environment, mobile health (mHealth) applications (apps) are becoming more and more important. The number of new mHealth apps has risen steadily in the last years.
Marc Holfelder, Lena Mulansky, Winfried Schlee, Harald Baumeister, Johannes Schobel, Helmut Greger, Andreas Hoff, Rüdiger Pryss   +7 more
doaj   +1 more source

Current medical device regulation: Is that enough? [PDF]

Farmacia Hospitalaria, 2019
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Juan Francisco Márquez-Peiró, Marisa Gaspar-Carreño   +1 more
doaj   +1 more source

Evaluation of newly-developed glycated hemoglobin clinical analytic reagents and chromatography column on Tosoh HLC-723 G8 Analyzer

Practical Laboratory Medicine, 2023
Objective: To evaluate the performance of newly developed glycated hemoglobin (HbA1c) clinical analytic reagents and HPLC columns, applied on Tosoh HLC-723 G8 Analyzer.
Bo Yuan, Wei Yang, Na Zhang, Hongyan Shi, Shuangpeng Dong   +4 more
doaj   +1 more source

Translating medical device innovations to market - a Ugandan perspective

BMC Research Notes, 2023
There is a disparity between low and middle-income countries (LMICs) and high-income countries (HICs) in translating medical device innovations to the market, affecting health care service delivery.
Brian Matovu, Jackline Winfred Baluka, Mercy Takuwa, Lucy Kevin Namuli, Charles Norman Mpaata, Julius Mugaga, Benedict Mulindwa, Racheal Nalwoga, Maria K Wolters, Robert Tamale Ssekitoleko   +9 more
doaj   +1 more source

The Regulation of Medical Device Representatives: A Question of Trust?

Law, Technology and Humans, 2022
The introduction of new technologies in medical treatment has led to innovation in medical devices that are highly technical in their application and operation.
Bernadette Richards, Susannah Sage Jacobson, Mianna Lotz, Wendy Rogers   +3 more
doaj   +1 more source

Experiences of medical device innovators as they navigate the regulatory system in Uganda

Frontiers in Medical Technology, 2023
ObjectiveA medical device must undergo rigorous regulatory processes to verify its safety and effectiveness while in use. In low-and middle-income countries like Uganda however, medical device innovators and designers face challenges around bringing a ...
Brenda T. Nakandi, Owen Muhimbise, Ashley Djuhadi, Martha Mulerwa, Janet McGrath, Philippa Ngaju Makobore, Andrew M. Rollins, Robert T. Ssekitoleko   +7 more
doaj   +1 more source

Support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework

Frontiers in Reproductive Health, 2023
Urinary incontinence (UI) or involuntary loss of urine is a common chronic medical condition among women. It is estimated that 5%−70% of the population experiences incontinence with most studies suggesting 25%−45% of the population.
Edburga L. Krause, Anne M. Hattersley, Joan M. Abbinante-Nissen, Denise Gutshall, Kara E. Woeller   +4 more
doaj   +1 more source