Baxter International has tapped the artificial intelligence developer behind an automated test for diabetic retinopathy for a partnership focused on the company’s newly acquired Welch Allyn retinal camera.
Digital Diagnostics—which scored one of the FDA’s first AI clearances in 2018 with its IDx-DR system—will work with Baxter to secure an additional agency green light that will allow the program to work with the RetinaVue 700 Imager.
The companies said they expect to obtain the new clearance in 2023 and that the AI deal will be exclusive within the U.S. and nonexclusive outside the country. IDx-DR was previously cleared by the FDA for use with Tokyo-based Topcon’s NW400 retinal camera.
Formerly known as IDx, Digital Diagnostics uses its point-of-care AI system to scan pictures from a fundus camera to examine the blood vessels and other structures lining the back of the eye. The program is designed to spot the early signs of diabetic macular edema and retinopathy—with the latter condition causing 60,000 people with diabetes to go blind each year internationally, the company said.
However, only about 15% of people with diabetes receive the recommended annual diabetic eye exam, according to Baxter and Digital Diagnostics, with especially low rates among rural and underserved areas.
"Primary care providers want access to the latest diagnostic tools so that testing can be offered during office visits and easily incorporated into existing workflows," Baxter’s chief operating officer, Giuseppe Accogli, said in a statement. “Our partnership with Digital Diagnostics is integral in expanding our connected care diagnostics portfolio."
Baxter’s portfolio was given a big boost last year through its $10 billion acquisition of Hillrom, which had previously picked up Welch Allyn and its hardware in 2015. According to Baxter, its established RetinaVue 700 Imager has already been used to test more than 1 million patients in the U.S.