[Hinews] Hutom, a South Korean medical AI and digital surgical navigation company, announced on August 29, 2025, that it has successfully registered its gastric and renal surgery assistance solutions, RUS GA and RUS NE, along with its 3D modeling software, RUS CREATOR, with Hong Kong’s medical device regulatory authority. This milestone clears the way for Hutom to officially launch sales in the Hong Kong market, marking a significant step in its global expansion.

The RUS platform leverages advanced imaging technology to convert CT scans into detailed 3D models, enabling precise surgical planning and intraoperative navigation. Specifically designed for gastric and renal procedures, RUS GA and RUS NE facilitate meticulous preoperative planning, while RUS CREATOR provides patient-specific 3D modeling to optimize surgical outcomes.

(From left) RUS GA (Stomach) product image, RUS NE (Kidney) product image (Image provided by Hutom)
(From left) RUS GA (Stomach) product image, RUS NE (Kidney) product image (Image provided by Hutom)


Widely adopted in South Korea’s leading tertiary hospitals, the RUS series has recently expanded into thoracic surgery. The newly introduced RUS LUNG solution enhances the safety and precision of lung resection procedures by accurately rendering complex pulmonary vasculature and segmental anatomy.

Hutom’s global ambitions gained traction last year when its RUS Stomach solution received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The company also secured a provisional evaluation under South Korea’s New Medical Technology Assessment program. The Hong Kong registration is expected to accelerate Hutom’s penetration into the broader Asian market.
“Hong Kong’s approval opens critical pathways for us in Asia,” said Woojin Hyung, CEO of Hutom. “Our AI-driven surgical navigation tools are poised to improve patient outcomes in medical settings worldwide.”

저작권자 © Hinews 무단전재 및 재배포 금지
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