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.

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.