Digital Healthcare Wins FDA Approval For Retinal Risk Assessment System
Retinal Risk Assessment System
Digital Healthcare has won approval from FDA to pre-market its Retasure retinal risk assessment system and its iP technology platform.
Retasure is a simple, affordable solution that allows primary care physicians to capture digital images of diabetic patients' retinas in a non-invasive procedure that takes just a few minutes. The images are then transmitted over a secure, HIPPA compliant network to a board certified ophthalmologist at an accredited reading center for examination and assessment. Results are returned to the primary care physician within 72 hours.
Digital Healthcare has already announced several major contracts with primary diabetes care and ophthalmology providers in several states and is now planning general availability of the Retasure system throughout the United States. Retasure was introduced in the United States earlier this year, and more than one million diabetic patients world-wide receive annual retinal risk assessments using Digital Healthcare software. There are approximately 20 million diabetic patients in the United States, but it is estimated that only about half of them get regular retinal risk assessments.
Retasure offers several advantages to primary care physicians and their patients: It can be operated by non-clinicians; it is non-invasive and requires no dilation; it obtains exceptionally high-quality digital images of the retina using a simple-to-operate fundus camera; it returns results quickly to primary care physicians; and it encourages patient compliance for regular retinal assessment.
Digital Healthcare's iP technology platform is an integrated workflow management engine designed to connect and share critical clinical information across 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 outcome management.
"FDA approval for Retasure and our iP technology platform marks a major step forward in the development of Digital Healthcare," said Marc Winchester, President, North America and Board Director of Digital Healthcare. "Pre-market approval clears the way for the company to market our products and services more widely.
"The approval not only covers our retinal risk assessment products such as Retasure, but also our next generation clinical ophthalmology technology which effectively integrates most instruments and technologies used in clinics using workflow management tools. These tools will improve both operational efficiency and the outcomes for many patients. Our reach now extends from the detection of eye disease, through diagnosis and patient outcome management."