Results 1 to 10 of about 9,793,032 (331)

Toxic or not toxic? The specifications of the standard ISO 10993-5 are not explicit enough to yield comparable results in the cytotoxicity assessment of an identical medical device

Frontiers in Medical Technology, 2023
Background Medical device manufacturers are obliged to prove the biocompatibility of their products when they come into contact with the human body. The requirements for the biological evaluation of medical devices are specified by the international ...
S. Gruber, Angela Nickel
semanticscholar   +1 more source

A Review of Biomedical Devices: Classification, Regulatory Guidelines, Human Factors, Software as a Medical Device, and Cybersecurity

Biomedical Materials & Devices, 2023
Biomedical devices provide a critical role in the healthcare system to positively impact patient well-being. This paper aims to provide the current classifications and subclassifications of hardware and software medical devices according to the Food and ...
Felix Tettey, Santosh Kumar Parupelli, Salil Desai   +2 more
semanticscholar   +1 more source

Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives

Expert Review of Medical Devices, 2023
Introduction Artificial intelligence (AI) encompasses a wide range of algorithms with risks when used to support decisions about diagnosis or treatment, so professional and regulatory bodies are recommending how they should be managed.
A. Fraser, E. Biasin, B. Bijnens, N. Bruining, E. Caiani, Koen Cobbaert, R. Davies, S. Gilbert, Leo Hovestadt, Erik Kamenjašević, Z. Kwade, Gearóid McGauran, Gearóid O'Connor, B. Vasey, F. Rademakers   +14 more
semanticscholar   +1 more source

Evaluation of an artificial intelligence-based medical device for diagnosis of autism spectrum disorder

npj Digital Medicine, 2022
Autism spectrum disorder (ASD) can be reliably diagnosed at 18 months, yet significant diagnostic delays persist in the United States. This double-blinded, multi-site, prospective, active comparator cohort study tested the accuracy of an artificial ...
Jonathan T. Megerian, Sangeeta Dey, R. Melmed, D. Coury, M. Lerner, C. Nicholls, K. Sohl, Rambod Rouhbakhsh, Anandhi Narasimhan, Jonathan E. Romain, Sailaja Golla, Safiullah Shareef, Andrey Ostrovsky, Jennifer Shannon, Colleen Kraft, Stuart Liu-Mayo, H. Abbas, Diana E. Gal-Szabo, D. Wall, S. Taraman   +19 more
semanticscholar   +1 more source

Medical Device Product Innovation Choices in Asia: An Empirical Analysis Based on Product Space

Frontiers in Public Health, 2022
Due to the increasing demand for health care, identifying and evaluating the feasibility of local medical device innovation and production is an important guarantee for the long-term sustainable development of a national health system, especially for ...
Fengxu Hu, Liping Qiu, Haiyan Zhou
semanticscholar   +1 more source

The EU medical device regulation: Implications for artificial intelligence-based medical device software in medical physics.

Physica medica (Testo stampato), 2021
Medical device manufacturers are increasingly applying artificial intelligence (AI) to innovate their products and to improve patient outcomes. Health institutions are also developing their own algorithms, to address specific needs for which no ...
R. Beckers, Z. Kwade, F. Zanca, Physica Medica   +3 more
semanticscholar   +1 more source

Pediatric Medical Device Development and Regulation: Current State, Barriers, and Opportunities.

Pediatrics, 2022
Few medical devices are designed and marketed specifically for children. Instead, adult devices are often repurposed and used off-label in pediatrics. The innovation gap between pediatric and adult devices is complex and multifactorial.
Juan C Espinoza, P. Shah, Gautam Nagendra, Y. Bar-Cohen, Frances J. Richmond   +4 more
semanticscholar   +1 more source

Will the EU Medical Device Regulation help to improve the safety and performance of medical AI devices?

Digital Health, 2022
Concerns have been raised over the quality of evidence on the performance of medical artificial intelligence devices, including devices that are already on the market in the USA and Europe.
E. Niemiec
semanticscholar   +1 more source

Complexity stage model of the medical device development based on economic evaluation-MedDee [PDF]

, 2020
The development of a new product is essential for the progress and success of any company. The medical device market is very specific, which is challenging. Therefore, this paper assesses an economic model for medical device evaluation using the economic,
Augustynek, Martin, Honegr, Jan, Klímová, Blanka, Kuča, Kamil, Marešová, Petra, Mohelská, Hana, Penhaker, Marek, Peter, Lukáš, Režný, Lukáš   +8 more
core   +1 more source

Novel Approaches to Combat Medical Device-Associated BioFilms

Coatings, 2021
Biofilms are aggregates formed as a protective survival state by microorganisms to adapt to the environment and can be resistant to antimicrobial agents and host immune responses due to chemical or physical diffusion barriers, modified nutrient ...
Xin Li, Lu-yao Sun, Peng Zhang, Yang Wang   +3 more
semanticscholar   +1 more source