Indian Regulators Approve First Ophthalmic AI Software—Medios DR from Remidio

India’s Remidio announced Sept. 13 that regulators there had approved its Medios DR software for autonomous detection of diabetic retinopathy (DR).

Medios DR becomes the first ophthalmic artificial intelligence software cleared for use in India, the company said. The system received CE marking in 2023 and was approved in Singapore in 2022.

Medios DR works with Remidio’s smartphone-based, hand-held, non-mydriatic fundus camera, the Fundus on Phone, to detect referable DR within 10 seconds, even offline.

Remidio said that millions of diabetics in India need to be screened for DR, but a shortage of ophthalmologists means that exams need to be done in primary care and rural settings. The system will bring essential eye care to communities that previously had limited access, Remidio said.