Image Quality Analyzer screening software receives 510(k) clearance
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The Image Quality Analyzer software system received 510(k) clearance from the FDA, VisionQuest Biomedical announced in a press release.
The software system prompts eye care professionals to retake digital fundus images when bright crescents, blurriness or poor illumination is detected, and makes suggestions for image quality improvement. The National Eye Institute, part of the NIH, provided funding for development, the release said.
The Clinicas del Azucar network in Mexico used Image Quality Analyzer software before the clearance for diabetic retinopathy screenings to determine readability of the images; in 98% of cases, the images were interpreted without dilation, according to the release.
“Other systems that use AI for detection of diabetic retinopathy need to dilate between 13% and 29% of patients,” Simon Barriga, PhD, VisionQuest founder and CEO, said in the release.
The company plans to use the software to continue developing its EyeStar and ASPIRE products.
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