Digital Healthcare retinal imaging system obtains pre-market approval

Wake Forest, NC-Digital Healthcare Inc. has received FDA approval to pre-market its retinal risk assessment system (Retasure) and its technology platform (iP).

Using the risk assessment system, primary-care physicians capture digital images of the retinas of patients with diabetes, then transmit the images over a secure, Health Insurance Portability and Accountability Act-compliant network for review by a board-certified ophthalmologist at an accredited reading center. Physicians receive results within 72 hours.

The system was introduced in the United States earlier this year, and more than 1 million patients have been assessed with it. The company already has contracts with providers of primary and ophthalmologic care in several states and now plans to make the system available throughout the United States.

The risk assessment system obtains high-resolution digital images of the retina using a fundus camera. The speed with which results are returned to primary-care physicians encourages patient adherence for regular retinal assessments, according to the company.

The technology platform is an integrated workflow management engine designed to connect and share critical clinical information across primary and secondary care functions.

“FDA approval . . . marks a major step forward in the development of Digital Healthcare,” said Marc Winchester, president for North America and board director, Digital Healthcare. “Pre-market approval clears the way for the company to market our products and services more widely.”