Seoul National Hospital’s MEDI:GATE Supports Soames FDA Approval

Seoul National University Hospital announced on the 12th that it has recently completed the selection of companies to support confirmatory clinical trials for US FDA approval and has begun overseas clinical support for domestic SleepTech medical devices.

This is part of the ‘AI-based Sleep Tech international cooperation demonstration support’ project, which is a detailed task of the ‘Bionano Industry Open Ecosystem Creation Project’ promoted by the Ministry of Trade, Industry and Energy.

Sleep disease is a major health problem associated with various chronic diseases, and the domestic and overseas sleep industry has recently been growing rapidly, focusing on AI-based sleep tech and digital therapy devices. Overseas, the standardization of SleepTech products based on clinical evidence and entry into the global market are in full swing, but the domestic SleepTech industry has limited clinical verification and international verification experience.

Accordingly, Seoul National University Hospital is supporting confirmatory clinical trials aimed at obtaining US FDA approval for AI-based SleepTech medical devices in the field of sleep disease prevention, diagnosis, and treatment to ensure that they are conducted in accordance with international standards.

As the lead organization, it oversees the overall clinical trials of SleepTech medical devices aiming for overseas approval, and supports the development of trial plans (protocols), preparation of basic documents, support for prior review and local approval procedures, performance management, and quality inspection, focusing on confirmatory clinical trials for US FDA and European CE MDR approval.

Seoul National University Hospital held a selection committee to select companies to support confirmatory clinical trials for US FDA approval, and after evaluation, Aimnext was selected as the final support target.

Aimnext is a company that developed the insomnia treatment application ‘Somzz’, Korea’s first digital therapy device (DTx) approved by the Ministry of Food and Drug Safety, and is preparing for clinical trials in the United States through this support. European clinical support will be recruited separately through an announcement in the second half of this year.

This project will be implemented from April 2025 to December 2029. The purpose is to provide the necessary support for clinical trials and approval preparation processes in the US and Europe for domestic medical devices in conjunction with government support to foster the SleepTech industry. Through this, we will lay the foundation for domestic Sleep Tech medical devices to accumulate overseas clinical experience and prepare for entry into the global market.

Lee Yu-jin, head of the Sleep Medicine Center (Department of Psychiatry) and the head of the study, said, “It is important for AI-based SleepTech and digital therapy devices to meet clinical evidence and international standards during the overseas approval process,” and added, “Seoul National University Hospital, as the host institution, is systematically supporting the clinical verification of SleepTech medical devices and the conduct of overseas clinical trials.”