IDx, the Coralville company behind the first and only FDA-cleared autonomous AI diagnostic system, has announced a new agreement with Topcon, a leading ophthalmic device manufacturer, to scale delivery of AI diagnostic solutions in the U.S. market.The agreement grants exclusive rights to IDx in the U.S. as the only autonomous AI company permitted to sell its products with the Topcon NW400, an easy to use, robotic fundus camera - essentially a low-power microscope with an attached camera. The fundus is the interior lining of the eyeball. 


 In turn, IDx has agreed to assign Topcon's NW400 as the only robotic desktop fundus camera with less than a 55-degree field of view to be integrated with IDx-DR, its autonomous system that allows health care providers to detect diabetic retinopathy, an eye disease that causes blindness in about 30,000 Americans a year.


 "Topcon is truly the innovative market leader in developing highly automated, consistent and easy to use retinal imaging systems," IDx President Dr. Michael Abramoff said in a release. "Together we can prevent visual loss and blindness by ensuring the safety, accessibility, and affordability of early disease detection."


 Both companies have a history of innovation. IDx received FDA clearance for IDx-DR in April, marking the first time the FDA has cleared an autonomous AI diagnostic system that does not require a physician to interpret images or results.


 New Jersey-based Topcon introduced the first commercial back-of-the-eye spectral domain (SD) and swept source (SS) optical coherence tomography (OCT) systems, and recently announced the release and class II clearance of Topcon Harmony, a diagnostic data management application that enables software providers, electronic health record managers and third-party manufacturers to seamlessly integrate diagnostic results into a central location.


Being the first to crack the medical artificial intelligence (AI) code has paid off in a big way for Coralville-based IDx, which last week secured $33 million in funding from four strategic investors in one of the largest venture capital deals in Iowa history. In late September, the University of Iowa spinout announced it has secured $33 million in funding from four strategic investors in one of the largest venture capital deals in the state's history. Its IDx-DR system is already in use by UI Health Care, marking the first time U.S. patients have received a medical diagnosis from an autonomous AI system.