Breakthrough device’ gets expedited review from FDA

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 syst intended for use in the front lines of healthcare.{{quote-A:R-W:450-I:2-Q: Too many patients go blind needlessly because they aren’t diagnosed in time, -WHO:Dr Michael Abràmoff, founder and president of IDx}}Dr Michael Abràmoff, founder and president of IDx, the Iowa-based company behind the syst, 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 syst 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.