FDA grants breakthrough device designation to artificial intelligence diagnostic system
The FDA is expediting the review of an artificial intelligence-based diagnostic system for the autonomous detection of diabetic retinopathy, according to a press release from IDx.
The company filed a de novo submission, and the FDA granted the system breakthrough device designation, allowing it to receive expedited review, the release said.
“The FDA’s designation of IDx-DR as a breakthrough device confirms what we have believed for a long time,” Michael Abramoff, MD, PhD, the company’s founder and president, said in the release. “The health care 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.”
The IDx-DR, which analyzes images of the retina, is proposed to automatically detect more than mild diabetic retinopathy in adults with diabetes who have not previously been diagnosed with diabetic retinopathy.