US-based IDx has received CE mark approval for its secure cloud version of IDx-DR product and placed under Class IIa medical devices.
IDx-DR version 1.3’s secure cloud architecture provides diabetic retinopathy screening to frontline healthcare providers over the internet.
IDx chairman and CEO Gary Seamans said the last year’s introduction of IDx-DR to Europe was a watershed moment in improving accessibility to sight-saving screenings for patients with diabetes.
"Today’s release of the third version of our IDx-DR software – and its secure cloud delivery system – means that this technology is now available for scaled deployment," Seamans added.
With the approval, the automated diabetic retinopathy screening is available to customers in the 31 countries, which include the European Economic Area.
IDx-DR v1.3, which is hosted in HIPAA compliant facility, avoids the need for complex computations at the healthcare provider’s location. It features high-end processors to analyze retinal images and deliver results to the provider in few seconds.
IDx co-founder and president Dr Michael Abramoff said: "Moving our screening software into a server-based environment means more secure processing, easier access and faster results than ever before."