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Digital Healthcare Wins FDA Approval for Retasure

Thursday, September 20, 2007 General News
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WAKE FOREST, N.C., Sept. 19 Digital Healthcare Inc., aretinal risk assessment and disease management company based in Wake Forest, NC,announced today that it has won approval from the U.S. Food and DrugAdministration to pre-market its Retasure retinal risk assessment system and itsiP(R) technology platform.
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Retasure is a simple, affordable solution that allows primary carephysicians to capture digital images of diabetic patients' retinas in anon-invasive procedure that takes just a few minutes. The images are thentransmitted over a secure, HIPPA compliant network to a board certifiedophthalmologist at an accredited reading center for examination and assessment.Results are returned to the primary care physician within 72 hours.
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Digital Healthcare has already announced several major contracts withprimary diabetes care and ophthalmology providers in several states and is nowplanning general availability of the Retasure system throughout the UnitedStates. Retasure was introduced in the United States earlier this year, and morethan one million diabetic patients world-wide receive annual retinal riskassessments using Digital Healthcare software. There are approximately20 million diabetic patients in the United States, but it is estimated that onlyabout half of them get regular retinal risk assessments.

Retasure offers several advantages to primary care physicians and theirpatients: It can be operated by non-clinicians; it is non-invasive and requiresno dilation; it obtains exceptionally high-quality digital images of the retinausing a simple-to-operate fundus camera; it returns results quickly to primarycare physicians; and it encourages patient compliance for regular retinalassessment.

Digital Healthcare's iP(R) technology platform is an integrated workflowmanagement engine designed to connect and share critical clinical informationacross primary and secondary care. The system uses ultra-secure communications,high resolution digital imaging, patient, physician and clinic management,standardized assessment, grading and reporting together with patient outcomemanagement.

"FDA approval for Retasure and our iP(R) technology platform marks a majorstep forward in the development of Digital Healthcare," said Marc Winchester,President, North America and Board Director of Digital Healthcare. "Pre-marketapproval clears the way for the company to market our products and services morewidely.

"The approval not only covers our retinal risk assessment products such asRetasure, but also our next generation clinical ophthalmology technology whicheffectively integrates most instruments and technologies used in clinics usingworkflow management tools. These tools will improve both operational efficiencyand the outcomes for many patients. Our reach now extends from the detection ofeye disease, through diagnosis and patient outcome management."

Digital Healthcare is the global leader in retinal risk assessment. They arethe world's leading provider of care management programs for diabeticretinopathy. Their award-winning MS-HUG technology is used by leading hospitalsand research centers including Case Western University, The Wilmer Eye Instituteat The Johns Hopkins University and the United States Military.

SOURCE Digital Healthcare Inc.
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