SFDA authorises two Saudi-developed AI medical software products

The Saudi Food and Drug Authority (SFDA) has granted marketing authorisation to two Saudi-developed AI-enabled medical software products designed to support dental and ophthalmic diagnosis.

The products, Dental IQ and SAARIA, underwent regulatory assessment by the SFDA, including reviews of technical documentation and clinical evidence relating to their safety, performance and intended uses, according to the authority.

Dental IQ uses deep-learning algorithms to analyse dental X-ray images and identify potential findings associated with conditions including dental caries, periodontal disease and structural changes affecting teeth and surrounding tissues. The software is intended to support healthcare professionals in diagnosis and treatment planning.

SAARIA analyses retinal fundus images to support the screening of diabetic patients for diabetic retinopathy. The software is designed to help identify patients who may require further ophthalmic assessment, potentially supporting earlier referral and intervention.

According to the SFDA, the two products are the first Saudi-developed AI-enabled medical software solutions in the dental and ophthalmic fields to receive its marketing authorisation.

Both products were developed by Saudi startups and were enrolled in the SFDA’s Innovative Medical Devices Pathway, which provides regulatory guidance to developers of innovative medical technologies.

The companies also conducted clinical studies in Saudi Arabia to assess the performance of their software in local healthcare settings. The SFDA said the developers have committed to post-marketing clinical follow-up to monitor the products’ performance following market entry.

The authorisations form part of Saudi Arabia’s wider efforts to develop and localise digital health technologies and expand the use of AI in healthcare.

The SFDA stressed, however, that the software is intended to support rather than replace clinical decision-making. Healthcare professionals remain responsible for reviewing and validating AI-generated outputs and making decisions based on the individual patient’s condition.

The authority said the regulatory approvals reflect its approach to supporting innovation in medical devices while maintaining requirements relating to safety, effectiveness and quality. The development also aligns with Saudi Arabia’s broader digital health and healthcare transformation objectives under Vision 2030.