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VisionQuest Gains FDA 510(k) Clearance for the Image Quality Analyzer Software
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<span>VisionQuest Gains FDA 510(k) Clearance for the Image Quality Analyzer Software</span>
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December 30, 2020
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<p>VisionQuest announced that on December 24, 2020, the company received 510(k) clearance from the United States Food and Drug Administration (FDA) to market the Image Quality Analyzer (IQA) software, which reduces unreadable images captured in teleretinal screening programs by retinal photographers.</p>
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<p>The IQA is a software system intended for use in importing, displaying, analyzing and managing images acquired with digital fundus cameras. The patented software detects the most common causes of retinal imaging artifacts: bright crescents, blurriness, and poor illumination. The software then prompts the user to retake the image and provides clues for improving the image quality. The software can be used with both tabletop and portable retinal cameras.</p>
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<p>The IQA was developed through funding provided by the National Eye Institute (NEI), which is part of the National Institutes of Health (NIH). “NEI’s funding allowed us to bring the product from concept to a fully tested and validated system that will help reduce the burden of blindness and increase accessibility of retinal exams,” said Peter Soliz, Ph.D., Founder, CTO, and Chairman of VisionQuest.</p>
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