Search Results - "Eydelman, Malvina"
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Foundational Considerations for Artificial Intelligence Using Ophthalmic Images
Published in Ophthalmology (Rochester, Minn.) (01-02-2022)“…The development of artificial intelligence (AI) and other machine diagnostic systems, also known as software as a medical device, and its recent introduction…”
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FDA Facilitating Innovation of Ophthalmic Devices While Balancing the Need for Safety and Effectiveness
Published in JAMA ophthalmology (01-04-2022)Get more information
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The Food and Drug Administration's Latest Efforts to Improve Safe Use of Hydrogen Peroxide Contact Lens Solution
Published in Eye & contact lens (30-07-2024)Get full text
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The US Food and Drug Administration's efforts to support ophthalmology clinical trials
Published in JAMA ophthalmology (01-12-2014)Get more information
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Considerations for addressing bias in artificial intelligence for health equity
Published in NPJ digital medicine (12-09-2023)“…Health equity is a primary goal of healthcare stakeholders: patients and their advocacy groups, clinicians, other providers and their professional societies,…”
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Special Report: American Academy of Ophthalmology Task Force Consensus Statement for Extended Depth of Focus Intraocular Lenses
Published in Ophthalmology (Rochester, Minn.) (01-01-2017)Get full text
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From Data to Deployment: The Collaborative Community on Ophthalmic Imaging Roadmap for Artificial Intelligence in Age-Related Macular Degeneration
Published in Ophthalmology (Rochester, Minn.) (01-05-2022)“…Health care systems worldwide are challenged to provide adequate care for the 200 million individuals with age-related macular degeneration (AMD). Artificial…”
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The Collaborative Community on Ophthalmic Imaging: Accelerating Global Innovation and Clinical Utility
Published in Ophthalmology (Rochester, Minn.) (01-02-2022)Get full text
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Special Commentary: Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery: Summary of a Joint Meeting of the American Glaucoma Society and the Food and Drug Administration, Washington, DC, February 26, 2014
Published in Ophthalmology (Rochester, Minn.) (01-09-2015)Get full text
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The US Food and Drug Administration's New Regulatory Toolkit to Bring Medical Device Innovation Back to the United States
Published in JAMA ophthalmology (01-04-2016)Get more information
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Assessment of Clinical Trials for Devices Intended to Control Myopia Progression in Children
Published in Eye & contact lens (01-07-2018)“…The increased prevalence of myopia in the United States and other regions of the world, and the sight-threatening problems associated with higher levels of…”
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Food and Drug Administration, American Academy of Ophthalmology, American Academy of Optometry, American Association for Pediatric Ophthalmology and Strabismus, American Optometric Association, American Society of Cataract and Refractive Surgery, and Contact Lens Association of Ophthalmologists Co-Sponsored Workshop: Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices
Published in Eye & contact lens (01-07-2018)“…The prevalence of myopia is high and increasing. Approximately 5 billion people around the world are expected to be myopic by the year 2050. Methods to slow…”
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Tapping Into Valuable Expertise From Private Practitioners and Academicians: Casting a Wider Net
Published in JAMA ophthalmology (01-08-2015)Get more information
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Special Report: American Academy of Ophthalmology Task Force Recommendations for Specular Microscopy for Phakic Intraocular Lenses
Published in Ophthalmology (Rochester, Minn.) (01-01-2017)Get full text
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Food and Drug Administration Procedures for New Drug and Device Approvals
Published in American journal of ophthalmology (2016)“…To be regarded as "adequate and well-controlled," studies must demonstrate a number of qualities: (1) they should have a clear statement regarding objectives…”
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The Definition of Glaucomatous Optic Neuropathy in Artificial Intelligence Research and Clinical Applications
Published in Ophthalmology. Glaucoma (01-07-2023)“…Although artificial intelligence (AI) models may offer innovative and powerful ways to use the wealth of data generated by diagnostic tools, there are…”
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Detecting endotoxin contamination of ophthalmic viscosurgical devices: intracameral versus intravitreal assays in rabbits
Published in Ophthalmology (Rochester, Minn.) (01-07-2012)“…To compare the sensitivities of intracameral and intravitreal assays in the rabbit model to determine the relative adequacy of these methods in detecting…”
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Study design considerations for sleep-disordered breathing devices
Published in Journal of clinical sleep medicine (15-03-2020)“…In recent years, sleep-disordered breathing (SDB) has been recognized as a prevalent but under-diagnosed condition in adults and has prompted the need for new…”
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