IDx, an Artificial Intelligence diagnostics company, has recently announced that it has put forth its premarket approval (de novo submission) to the FDA for its IDx-DR. Reportedly, the product is powered by the AI technology for the automatic detection of diabetic retinopathy, which apparently is one of the leading causes of blindness in diabetes patients.
The FDA has granted the IDx-DR with a designation of a “Breakthrough Device”, in turn allowing IDx to receive expedited review of its submission, cite trustworthy sources. For those unfamiliar, the breakthrough Device Program is especially reserved for technologies that are expected to provide more effective diagnosis or treatment toward life-threatening diseases.
Experts cite that if the FDA clears the de novo submission, the AI-based IDx-DR device is poised to become the first-of-its-kind diagnostic system in the diabetic retinopathy market. The use of this device on the front lines of the healthcare will in turn have a powerful impact on the growth statistics of diabetic retinopathy market, speculate industry analysts.
According to the Cision PRweb, over 30 million people are diagnosed with diabetes in America and 24,000 are estimated to lose vision every year in effect of diabetes complications, resulting into diabetic retinopathy. If the disease is diagnosed in the early stages, the blindness and vision loss in most cases are preventable, despite which only 50% of diabetic population is reported to undergo regular eye exams.
In a statement, Dr. Michael Abràmoff, founder and president of IDx, was quoted stating that the entire healthcare industry is in a desperate need of more cost-effective and efficient way to diagnose and detect diabetic retinopathy, as numerous patients lose their vision and go blind just because the disease is caught too late.
For the record, IDx’s breakthrough device analyzes images of the retina and automatically detects even the mildest of diabetic retinopathy symptoms in the adults who are already diagnosed with diabetes. Industry experts believe that this “Breakthrough Device” will practically change the face of advanced healthcare delivery, in turn stimulating diabetic retinopathy market growth.