The Saudi Food and Drug Authority (SFDA) granted marketing authorization on September 10 to two locally developed AI-enabled medical software products: Dental IQ for dental imaging and SAARIA for retinal imaging. The authority said its review assessed technical documentation and clinical evidence for safety, performance and effectiveness in the products’ intended uses. Dental IQ uses deep-learning analysis of dental X-rays to support identification of possible caries, periodontal disease and structural changes. SAARIA analyzes fundus images to support diabetic-retinopathy screening and flag patients who may need further ophthalmic assessment.

The SFDA described the products as clinical support tools, not substitutes for a healthcare professional’s judgment. It said the Saudi startups behind them completed local clinical studies and committed to post-market follow-up plans. The release characterized the authorizations as the first for Saudi-developed AI medical software in dentistry and ophthalmology. It did not disclose the products’ commercial launch dates, the number of facilities using them or measured outcomes in routine care.