US FDA Grants De Novo Request for IDx-DR’s AI Diagnostic System for Diabetic Retinopathy

April 13, 2018: By Jon Swedien
IDx-DR artificial intelligence diagnostic system

IDx-DR artificial intelligence diagnostic system

The FDA has granted IDx’ De Novo request to market the IDx-DR, an artificial intelligence (AI) diagnostic system for the autonomous detection of diabetic retinopathy, the agency announced April 12.

IDx-DR is the first autonomous, AI-based diagnostic system the FDA has authorized for commercialization, the agency said.

IDx-DR is designed to provide an immediate, reliable screening test for diabetic retinopathy, including macular edema, during a routine office visit in a primary care setting, Iowa-based IDx said. The IDx-DR makes an assessment without the need for a clinician to also interpret the image or results, making it usable by health care providers not normally involved in eye care, the company said.

“Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50 percent of them do not see their eye doctor on a yearly basis,” said Malvina Eydelman, MD, director of the FDA’s Division of Ophthalmic and Ear, Nose, and Throat Devices.

The exam is performed on site in minutes and produces a diagnostic interpretation and associated report, including care instructions that are aligned with American Academy of Ophthalmology guidelines for diabetic retinopathy, IDx said.

This enables primary care providers to counsel patients on follow-up care while they are still in the office, the company said.

IDx-DR received expedited review under the FDA’s Breakthrough Devices program following a pivotal clinical trial conducted at 10 primary care sites across the US, the company said.

IDx-DR is intended for use by health care providers to automatically detect more than mild diabetic retinopathy in adults above age 22 who are diagnosed with diabetes and have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400, IDx said.

A team of ophthalmologists at the University of Iowa Hospitals and Clinics founded IDx in 2010. The IDx-DR is the company’s first product.

Need Deeper Analysis? Sign up for Market Scope's monthly newsletter to get in-depth coverage of the ophthalmic market, including quarterly procedure volumes based on survey data and meeting coverage from around the world.

Recent Ophthalmic News

Ivantis Gains US FDA Approval for Hydrus Microstent

US FDA Approves Sun Pharma’s CEQUA for Dry Eye

Regeneron Receives US FDA Approval for 12-Week Eylea Dosing

STAAR, Japan’s Shinjuku LASIK Clinic Sign Multiyear Agreement

Alcon Launches Finesse Sharkskin ILM Forceps

Imprimis’ Q2-2018 Revenues Increase 51 Percent to $10.4 Million

Bausch Health Revenues in Q2-2018 Drop 5 Percent

TearLab’s Q2-2018 Revenues Drop 8.5 Percent to $6.4 Million

DeepMind AI System Accurately Detects Eye Disease in OCT Scans at Moorfields

Study by MIT, Mass Eye and Ear Suggests Glaucoma is Autoimmune Disease

Study Indicates Insulin May Restore Vision in Glaucoma

CHOP Researchers Define Six ROP Indicators

Nicox Initiates Phase II Study of NCX 470 in Open-Angle Glaucoma, Ocular Hypertension

Eyenovia’s Microdose Latanoprost Delivers Drug with Precision, Lowers IOP in Proof-of-Concept Study

Rayner to Launch Sulcoflex Trifocal Toric IOL in September

CMS Allows Medicare Advantage Plans to Apply Step Therapy to Retinal Injections

Glaukos Reports Drug Collaboration with D. Western, Q2-2018 Net Sales Increase of 5 Percent

Allergan Will Co-develop Editas’ CRISPR Genome Editing Candidate for LCA10

Spark Reports Q2-2018 Net Sales of $4.3 Million for Luxturna

Aerie’s Rhopressa Posts $2.4 Million in Net Revenues in Q2-2018

Coming soon

2018 Ophthalmic Laser Report: A Global Market Analysis for 2017 to 2023 (Photocoagulation, Photodisruption, and SLT