breakthrough device

‘Breakthrough device’ gets expedited review from FDA

The US Food and Drug Administration (FDA) has designated an AI diagnostic system that autonomously detects diabetic retinopathy (DR) as a ‘breakthrough device’, paving the way for an expedited review.

The Breakthrough Device Program is reserved for technologies that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.

Should it receive clearance the IDx-DR is expected to become a first-of-its-kind autonomous, AI-based diagnostic system intended for use in the front lines of healthcare.

“Too many patients go blind needlessly because they aren’t diagnosed in time,”Dr Michael Abràmoff, Founder And President Of IDx

Dr Michael Abràmoff, founder and president of IDx, the Iowa-based company behind the system, said he and his colleagues developed IDx-DR so that people with diabetes could have their eyes tested for DR during routine office visits.

“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,” Abràmoff said.

“The FDA’s designation of IDx-DR as a ‘breakthrough device’ confirms what we have believed for a long time.”

IDx also has algorithms in development for the detection of macular degeneration, glaucoma, Alzheimer’s disease, cardiovascular disease, and stroke risk.

A clearance determination on IDx-DR is expected before the end of the year.

Article appeared on INSIGHT

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