Expert review of medical devices
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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.