Saudi Arabia’s Food and Drug Authority (SFDA) has granted marketing authorization to Dental IQ and SAARIA, two locally developed artificial intelligence-powered medical software products for dentistry and ophthalmology.
According to the SFDA, the products are the first Saudi AI medical software solutions to receive marketing authorization in these fields. The approval followed a review of technical files, clinical evidence, safety and performance requirements.
Dental IQ analyzes dental X-rays to identify potential indicators of tooth decay, gum disease and other changes affecting dental health. It is designed to support healthcare professionals in interpreting images and developing treatment plans.
SAARIA analyzes fundus images to help screen diabetic patients for early signs of diabetic retinopathy and identify cases that may require specialist assessment.
The products were developed by Saudi startups and underwent clinical studies in Saudi Arabia. Their developers also joined the SFDA’s innovative medical devices pathway and committed to post-market clinical follow-up plans.
The SFDA said the tools are intended to support, not replace, physicians and specialist assessments. The authorization marks a step for Saudi health-tech companies moving from product development through clinical validation and regulatory approval to market access.
Source: EntArabi
