Private diagnostics company Idx LLC reported its artificial intelligence (AI) system to detect diabetic retinopathy (DR) has met pivotal trial endpoints to assess patients for the disease in primary care. The 900-patient trial indicated the company's system, Idx-DR, is able to determine, within a few minutes, the presence of diabetic retinopathy among diabetic patients during a physician office appointment. The FDA granted breakthrough device designation and expedited review to the company earlier this month; the device has been under review since the start of 2018 with anticipated approval later in the year. Read More
