RTsafe’s PseudoPatient Receives Saudi FDA Authorization, Expanding Access to Advanced Radiotherapy QA Across the Kingdom

RTsafe is proud to announce that its core innovation, the PseudoPatient®, has received official Medical Device Marketing Authorization (MDMA-2-2026-0352) from the Saudi Food & Drug Authority (SFDA).

This important regulatory milestone enables RTsafe to market and distribute PseudoPatient across the Kingdom of Saudi Arabia and represents a significant step forward in the company’s global expansion strategy. The authorization follows the device’s prior 510(k) clearance by the U.S. Food and Drug Administration (FDA), further reinforcing the platform’s safety, reliability, and clinical value in modern radiation oncology.

According to the official SFDA authorization document,  RTsafe is authorized to market its patient-specific pre-radiotherapeutic end-to-end verification devices in the Kingdom enabling comprehensive end-to-end verification of radiotherapy treatments, supporting accuracy, confidence, and patient safety from imaging and treatment planning through dose delivery.

Saudi Arabia is undergoing rapid healthcare transformation under Vision 2030, with significant investments in oncology infrastructure and advanced radiotherapy technologies. With this authorization in place, RTsafe is positioned to collaborate with leading cancer centers and healthcare providers across the Kingdom, supporting national initiatives focused on treatment quality, innovation, and clinical excellence. The availability of PseudoPatient® in the Saudi market opens new opportunities for hospitals to strengthen their quality assurance workflows and adopt next-generation verification standards.

RTsafe extends its sincere appreciation to Welcome Health Ventures for their strategic regulatory guidance and support throughout the SFDA process. Their partnership played a key role in navigating the regulatory pathway and accelerating RTsafe’s expansion into the Middle East.
With both U.S. FDA 510(k) and Saudi FDA clearance now secured, RTsafe continues to strengthen its international regulatory footprint and expand global access to advanced end-to-end radiotherapy verification solutions. The Saudi authorization represents not only a validation of the technology but also a strategic gateway to broader regional growth across the Gulf and MENA markets.

RTsafe remains committed to advancing radiation oncology quality assurance worldwide and to supporting clinicians in delivering safe, precise, and effective cancer treatments.