IDx-DR

Businesspeople looking at financial charts.

Digital Diagnostics scores $75M to advance AI-backed diagnostic tech

By Emily Olsen 11:27 am August 23, 2022

AI-enabled diagnostics company Digital Diagnostics announced Tuesday it had raised $75 million in a Series B funding round led by KKR. Other participants in the raise include Cedar Pine, Kinderhook, 8VC, Optum Ventures, OSF Ventures, Gundersen Health System, Edward-Elmhurst Health Venture Capital and the University of Iowa. The company, previously known as IDx, said the Series B brings its total...

Study results support FDA approval of diagnostic algorithm, but experts remain wary

By Dave Muoio 03:17 pm August 28, 2018

Pivotal trial data that led to April’s de novo clearance of the first AI-based diagnostic system to not require clinician interpretation is now available to the public. Published today in npj Digital Medicine, this 900-patient investigation showed that the IDx-Dr system for autonomous detection of diabetic retinopathy “robustly exceeded the pre-specified primary endpoint goals” and is able to...

FDA permits marketing of AI software that autonomously detects diabetic retinopathy

By Dave Muoio 11:10 am April 12, 2018

The FDA has granted diagnostics company IDx’s De Novo request to market its AI-based software system for the autonomous detection of diabetic retinopathy in adults who have diabetes, called IDx-DR. This decision represents the first AI-based diagnostic system authorized by the FDA for commercialization in the US that can provide a screening decision without the need for clinician interpretation,...