VisionQuest Biomedical Inc. Gains FDA 510(k) Clearance for the Image Quality Analyzer Software

"ALBUQUERQUE, N.M.--(BUSINESS WIRE)--VisionQuest Biomedical Inc. (VisionQuest) announced today that the company has 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.

“NIH’s Small Business Innovation Research Grant (SBIR) program has allowed us to build a pipeline of healthcare products of which the IQA is the first to receive clearance in the US.”

Prior to FDA clearance, VisionQuest has used the IQA in the Clinicas del Azucar, a network of diabetes clinics in Mexico. IQA is used by nurses and medical technicians to ensure that the images they capture to screen for diabetic retinopathy, the most common cause of blindness in the working age population, are of sufficient quality for interpretation by a human reader or by artificial intelligence programs. Thanks to the IQA, 98% of the cases imaged at Clinicas del Azucar can be read without the need for pupil dilation.

“Good image quality is the cornerstone of a successful diabetic retinopathy screening program. The IQA ensures that images can be captured by minimally trained technicians, and that unnecessary dilation is avoided to capture adequate images,” said Simon Barriga, Ph.D., Founder and CEO of VisionQuest. “Other systems that use AI for detection of diabetic retinopathy need to dilate between 13% and 29% of patients, which severely hampers their adoption in primary care or retail clinics.”..." Lire la suite