FDA trial results – Breakthrough AI system to be revealed at Beverly Hills Hilton today from IDx.
A breakthrough AI diagnostic system that tests for diabetic retinopathy in primary care. Diabetic retinopathy is a complication of diabetes and a leading cause of blindness.
A number of retina specialists that are not affiliated with IDx will be in attendance and available for questions. This is a great opportunity to capture first impressions on the IDx-DR clinical trial from experts in the health-tech space.
IDx-DR has been under review by the FDA since January. The submission, which included data from the clinical trial, was granted expedited review under the FDA’s Breakthrough Device program.
If cleared by the U.S Food and Drug Administration, IDx-DR is expected to become the first-of-its-kind autonomous, AI-based diagnostic system intended for use in the front-lines of healthcare.
IDx is transforming healthcare by developing artificial intelligence that detects disease in primary care. The company produces autonomous AI diagnostic systems that analyze images for the same signs of disease as a clinician.
By providing a specialist diagnosis in the front-lines of healthcare, IDx aims to increase patient access to high-quality and affordable disease detection, so that disease is caught and treated early on.
The company recently completed an FDA clinical trial for its first product, IDx-DR, an AI-based diagnostic system that detects diabetic retinopathy, a leading cause of blindness.
They also has solutions in development for the detection of macular degeneration, glaucoma, Alzheimer’s disease, cardiovascular disease and stroke risk.
Founded in 2010 by renowned clinician scientists and has a strategic partnership with IBM Watson Health to distribute its products in the EU.