QT Imaging gains Saudi Arabia regulatory clearance for breast scanner

QT Imaging Holdings Inc. (NASDAQ: QTI) received regulatory clearance from Saudi Arabia's Food and Drug Authority for its Breast Acoustic CT scanner, the company announced. The approval allows the medical device company to market and sell its radiation-free breast imaging technology throughout the kingdom.

The clearance enables commercial deployment under QT Imaging's exclusive distribution agreement with Gulf Medical Co., signed in August 2025. Gulf Medical serves as a healthcare technology provider in Saudi Arabia and can now begin engaging healthcare institutions across the country.

Saudi Arabia represents one of the largest healthcare markets in the Middle East. The kingdom has increased healthcare investments as part of its Vision 2030 initiative and Health Sector Transformation Program, which focuses on improving healthcare access and preventive care infrastructure.

"Receiving SFDA approval is a major achievement for QT Imaging and an important step in our global commercialization strategy," said Satrajit Misra, Chief Commercial Officer. "This approval enables us to begin commercial deployment with our partner Gulf Medical and expands access to our radiation free, compression free 3D breast imaging technology for women throughout the Kingdom."

QT Imaging now holds regulatory clearances in both Saudi Arabia and the United Arab Emirates, establishing commercial access in the two largest Gulf region healthcare markets. The company develops imaging systems using low frequency sound waves for breast health management.

Breast cancer remains the most commonly diagnosed cancer among women in Saudi Arabia, according to data from the Global Cancer Observatory.

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