Computer-based Screening for Diabetic Retinopathy

Summary VisionQuest Biomedical LLCVisionQuesthas developed a diabetic retinopathyDRscreening systemEyeStarenabled by automated screening softwareDR RACSthat was developed under the EYPhase II SBIR projectOur product provides immediate feedback to the physician on the state of diabetic eye disease without burdening an eye care specialist to review those cases without retinal diseaseDiabetes affects overmillion Americansand DR is one of its main complicationsIf not detected earlyDR leads to vision loss and blindnessWith the number of diabetics projected to grow to overmillion byworldwide DR has become a serious healthcare concernDRRACS will improve DR screening rates by providing a solution that is low cost and integrated at the point of careand that will result in increased revenues for insurance companies and healthcare providersThe main objective of this grant application is to complete the final steps needed to commercialize VisionQuest s EyeStarDR screening systemFor commercializationVisionQuest requires FDA clearance of the enabling componentthe DR RACS softwareThis objective will be achieved through two specific aimsIn Aimwe will make VisionQuest and the DR RACS product compliant with the quality system regulationsQSRin preparation for regulatory submissionsIn Aimwe will prepare DR RACS for FDAksubmissionTo achieve this goalwe will prepare akpre submissioncarry out a multi center clinical studyand submit a De Novokapplication to the FDAAt the completion of this projectwe will have the first FDA cleared automated DR screening softwareWe will then be positioned to commercialize our automatic retinal screening systemEyeStarto serve the needs of the healthcare industry in the US and worldwide