Expert review of medical devices
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Expert Rev Med Devices · Oct 2020
ReviewEmerging technologies for diagnostics and drug delivery in the fight against COVID-19 and other pandemics.
A pandemic is the worst-case scenario in the field of infectious diseases. Innovative technologies have the potential to address the challenges associated with the manufacture of personalized drug delivery systems, biosensors, and medical devices during a pandemic. 3D-Printing, microfluidics, and Microelectromechanical systems (MEMS) can provide an important part on this fight, as are cheap, easy to be operated, capable to provide rapid detection and monitoring of a disease, and deliver medicines. ⋯ New manufacturing techniques are emerging with the ability to address the challenges associated with the development of medical devices or diagnostics, during a pandemic. Are many challenges in order to achieve this and especially in short times that are required under a pandemic attack, which will also be covered in this manuscript.
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Expert Rev Med Devices · Jun 2020
ReviewCOVID-19: ensuring our medical equipment can meet the challenge.
To predict the spread of coronavirus disease globally and consequently prepare the hospital facilities with the required technology is a challenge. The availability of essential medical equipment to support patients affected by Covid-19 is globally limited. Areas covered This perspective gives a technical view of the pandemic focusing on the main actions taken by regulatory agencies to cope with the shortage of devices. ⋯ In this exceptional situation scientist and technology experts in collaboration with medical specialists should work together to re-assess the risk analysis on medical equipment management and their use and re-use in this context with the aim to improve global health care Every effort must be made to provide the necessary devices at least with the minimum acceptable performances for Covid-19 patients while maintaining a high standard of safety for users. The aim of the present manuscript is to highlight the technical challenges in order to prevent, through targeted actions, operating standards from falling below the standards of care due to a lack of medical devices. Abbreviations AKI: acute Kidney Injury; ARGMD: Australian Regulatory Guidelines for Medical Devices; Covid-19: Coronavirus disease; FDA: Food and Drug Administration; ECMO: Extracorporeal Membrane Oxygenation; EU: European Union; ICU: Intensive Care Unit; WHO: World Health Organization; MHRA: Medicines and Healthcare products Regulatory Agency; MDR: Medical Device Regulation; SARI: Severe Acute Respiratory Infection.
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Expert Rev Med Devices · Jun 2020
ReviewArtificial intelligence: improving the efficiency of cardiovascular imaging.
Artificial intelligence (AI) describes the use of computational techniques to mimic human intelligence. In healthcare, this typically involves large medical datasets being used to predict a diagnosis, identify new disease genotypes or phenotypes, or guide treatment strategies. Noninvasive imaging remains a cornerstone for the diagnosis, risk stratification, and management of patients with cardiovascular disease. AI can facilitate every stage of the imaging process, from acquisition and reconstruction, to segmentation, measurement, interpretation, and subsequent clinical pathways. ⋯ Cardiovascular medicine is primed for scalable AI applications which can interpret vast amounts of clinical and imaging data in greater depth than ever before. AI-augmented medical systems have the potential to improve workflow and provide reproducible and objective quantitative results which can inform clinical decisions. In the foreseeable future, AI may work in the background of cardiac image analysis software and routine clinical reporting, automatically collecting data and enabling real-time diagnosis and risk stratification.
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Expert Rev Med Devices · Dec 2019
Device profile of the Nerivio™ for acute migraine treatment: overview of its efficacy and safety.
Introduction: Noninvasive neuromodulation devices represent an emerging field in the acute treatment of migraine. High efficacy, favorable safety profile, good tolerability and low cost are important factors for the desired shift to non-pharmacological treatments. This will have the potential to improve the quality of life of people with migraine and reduce the risk for adverse events and medication overuse headache (MOH). ⋯ Post-hoc analyses suggest that the efficacy of REN is non-inferior to usual care in general and to acute pharmacological treatments specifically. Expert commentary: Nerivo™ integrates clinically meaningful efficacy with a high safety profile, satisfying a great unmet need in migraine acute care. The unique mechanism of action, in which the electrical stimulation is applied to peripheral nerves in the upper arm, permits the introduction of an innovative device with high efficacy and superior and improved usability aspects compared with acute pharmacological treatments and other approved devices.
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Expert Rev Med Devices · Jul 2019
ReviewDural sealants for the management of cerebrospinal fluid leakage after intradural surgery: current status and future perspectives.
Introduction: Cerebrospinal fluid leakage is a complication after intradural surgery and is associated with severe secondary complications like compromised wound healing and meningitis. Dural sealants are meant to augment the primary dural closure in order to achieve a watertight closure. Areas covered: This review summarizes the efficacy of currently available dural sealants. ⋯ However, based on the efficacy of currently available dural sealants according to systematic reviews and in vitro studies, a significant effective dural sealant seems is still lacking. A new dural sealant has to be thoroughly assessed before clinical application in in vitro, in vivo and clinical trials. A new research area within sealant development might be the introduction of dural sealants with both antimicrobial and analgesic properties.