The US Food and Drug Administration (FDA) has granted a “Breakthrough Device” designation to an Artificial Intelligence-based system for the autonomous detection of diabetic retinopathy. Known as the IDx-DR, the system analyses images of the retina for signs of disease and provides instructions for follow-up care based on the level of disease detected.
The Breakthrough Devices program is reserved for breakthrough technologies that “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases”.1 It enables submissions to be expedited for review. If cleared by the FDA, the device is expected to become the first of its kind autonomous, AI-based diagnostic system intended for use in the front lines of healthcare.
“The FDA’s designation of IDx-DR as a ‘breakthrough device’ confirms what we have believed for a long time,” said Dr. Michael Abramoff, founder and president of IDx, which developed the of IDx-DR. “The healthcare system desperately needs a more efficient and cost-effective way to detect diabetic retinopathy.
Too many patients go blind needlessly because they aren’t diagnosed in time.” Dr. Abramoff and his colleagues hope the technology will make early disease detection more accessible and affordable for patients.
They say IDx-DR’s proposed indications for use would enable health care providers to automatically detect more than mild diabetic retinopathy (mtm-DR) in adults with diabetes who have not been previously diagnosed with diabetic retinopathy.