Hutom Participates in the International Symposium on AI-Based Medical Products Regulation

Hutom, a medical artificial intelligence (AI) and digital surgical navigation specialist, announced on the 10th that it will participate in the 'International Artificial Intelligence (AI) Medical Product Regulation Symposium (AI Regulatory & International Symposium, AIRIS 2025)' held at the Inspire Hotel in Incheon for three days from September 10th to 12th.

This event, co-hosted by the Korea Ministry of Food and Drug Safety and the World Health Organization (WHO), serves as a crucial forum for discussing global regulations for AI-based medical products. This year's event, themed "Global AI Regulatory Harmonization: Opening the Future Together," will bring together regulatory authorities, industry experts, and academics from around the world to share technology and regulatory trends in AI medical products and discuss future prospects.

At this event, Hutom will be attending alongside Johnson & Johnson Medtech Korea, a global medical device company with which it signed a joint promotional agreement last year, and will be demonstrating its collaborative product, surgical navigation RUS, at the booth event.

Hutom's RUS platform is a software platform that uses computed tomography (CT) images to create a 3D representation of a patient's anatomy, supporting preoperative planning and intraoperative navigation. Solutions for gastric and renal surgery help medical professionals plan more precisely and efficiently, while the RUS CREATOR, also listed, enables personalized 3D modeling and surgical plan optimization.

RUS, a commercialized surgical navigation platform in Korea, is an innovative medical product that provides surgeons with insight into their operations and ultimately aims to improve surgical outcomes and patient prognosis. Last year, RUS Stomach received 510(k) approval from the U.S. Food and Drug Administration (FDA). It was also designated as a deferred evaluation new medical technology in Korea and is being used in major hospitals.

It is currently being actively used at major general hospitals in Korea, and in May of last year, a joint promotional agreement was signed with Johnson & Johnson Medtech Korea to expand its sales network for domestic gastric and kidney cancer surgeries. Recently, "RUS Lung," a lung resection assistance solution that expands its application to the thoracic region, completed domestic certification, drawing attention as a product that enhances surgical safety by precisely visualizing complex pulmonary blood vessels and segmental structures.

“Hutom, a leader in the medical AI industry, is committed to revolutionizing operating rooms using AI,” said Hyungwoo Jin, CEO of Hutom. “We will take the lead in creating an environment where AI technology can be utilized safely and healthily, thereby providing better services to medical professionals and patients.”


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