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Management: Food and Drug Administration (FDA)
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Total 36 results found since Jan 2013.
US regulatory considerations for low field magnetic resonance imaging systems
MAGMA. 2023 May 16. doi: 10.1007/s10334-023-01083-1. Online ahead of print.ABSTRACTAlthough there has been a resurgence of interest in low field magnetic resonance imaging (MRI) systems in recent years, low field MRI is not a new concept. FDA has a long history of evaluating the safety and effectiveness of MRI systems encompassing a wide range of field strengths. Many systems seeking marketing authorization today include new technological features (such as artificial intelligence), but this does not fundamentally change the regulatory paradigm for MR systems. In this review, we discuss some of the US regulatory considerati...
Source: Magma - May 16, 2023 Category: Radiology Authors: Daniel Michael Krainak Rongping Zeng Ningzhi Li Terry O'Riska Woods Jana Gut Delfino Source Type: research
Lung Imaging of COPD: Part 2: Emerging Concepts Lung Imaging in COPD: Part 2: Emerging Concepts
This article discusses important emerging techniques in imaging patients with COPD. The clinical utility of these emerging techniques as they stand today are tabulated for the benefit of the practicing pulmonologist., Abbreviation: BLVR - bronchoscopic lung volume reduction, LVRS - lung volume reduction surgery., LAAs - low attenuating areas., PD15 - lowest 15th percentile of lung histogram, FDA - Food and Drug Administration, Author Conflicts of Interest.PMID:36907375 | DOI:10.1016/j.chest.2023.02.049
Source: Chest - March 12, 2023 Category: Respiratory Medicine Authors: Suhail Raoof Manav Shah Sidney Braman Abhinav Agrawal Hassan Allaqaband Russell Bowler Peter Castaldi Dawn DeMeo Shannon Fernando Charles Scott Hall Meilan Han James Hogg Stephen Humphries Ho Yun Lee Kyung Soo Lee David Lynch Stephen Machnicki Atul Mehta Source Type: research
Iron oxide nanoparticles inhibit tumor growth by ferroptosis in diffuse large B-cell lymphoma
In this study, we further demonstrated the effect of IONs on inhibiting the growth of diffuse large B-cell lymphoma (DLBCL) cells by enhancing ferroptosis-mediated cell death. IONs treatment caused an accumulation of intracellular ferrous iron and the onset of lipid peroxidation in DLBCL cells as well as the suppressed expression of anti-ferroptosis protein Glutathione Peroxidase 4 (GPX4), thereby leading to increased ferroptosis. Mechanistically, IONs increased cellular lipid peroxidation through the generation of ROS via the Fenton reaction and regulating the iron metabolism-related proteins, such as ferroportin (FPN) an...
Source: Cell Research - March 10, 2023 Category: Cytology Authors: Qi-Tang Huang Quan-Quan Hu Zhao-Feng Wen Yan-Li Li Source Type: research
Noninvasive Plaque Imaging to Accelerate Coronary Artery Disease Drug Development
Circulation. 2022 Nov 29;146(22):1712-1727. doi: 10.1161/CIRCULATIONAHA.122.060308. Epub 2022 Nov 28.ABSTRACTCoronary artery disease (CAD) remains the leading cause of adult mortality globally. Targeting known modifiable risk factors has had substantial benefit, but there remains a need for new approaches. Improvements in invasive and noninvasive imaging techniques have enabled an increasing recognition of distinct quantitative phenotypes of coronary atherosclerosis that are prognostically relevant. There are marked differences in plaque phenotype, from the high-risk, lipid-rich, thin-capped atheroma to the low-risk, quies...
Source: Atherosclerosis - November 28, 2022 Category: Cardiology Authors: Gemma A Figtree Philip D Adamson Charalambos Antoniades Roger S Blumenthal Michael Blaha Matthew Budoff David S Celermajer Mark Y Chan Clara K Chow Damini Dey Girish Dwivedi Nicola Giannotti Stuart M Grieve Christian Hamilton-Craig Bronwyn A Kingwell Jaso Source Type: research
Polymyalgia Rheumatica and Giant Cell Arteritis: Rapid Evidence Review
Am Fam Physician. 2022 Oct;106(4):420-426.ABSTRACTPolymyalgia rheumatica and giant cell arteritis are inflammatory conditions that occur predominantly in people 50 years and older, with peak incidence at 70 to 75 years of age. Polymyalgia rheumatica is more common and typically presents with constitutional symptoms, proximal muscle pain, and elevated inflammatory markers. Diagnosis of polymyalgia rheumatica is clinical, consisting of at least two weeks of proximal muscle pain, constitutional symptoms, and elevated erythrocyte sedimentation rate or C-reactive protein. Treatment of polymyalgia rheumatica includes moderate-do...
Source: Pain Physician - October 19, 2022 Category: Anesthesiology Authors: Meghan F Raleigh Jonathan Stoddard Hillary J Darrow Source Type: research
