[Edaily Reporter KIM SAE-MI ] VUNO, Inc.(338220)is set to enter Hainan Province, China, with its artificial intelligence (AI)-based cardiac arrest prediction medical device, “VUNO Med-DeepCARS.” The company has signed an exclusive distribution agreement with a local medical specialist firm and will conduct a proof of concept (PoC) at hospitals within the medical special economic zone prior to obtaining official approval in China.

VUNO, Inc. announced on the 28th that it has signed an exclusive sales agreement for DeepCARS in Hainan Province with Guorun, a Chinese medical company.

This agreement, which follows a signing ceremony held by the two companies in Hainan Province, China, last May, has a term of two years. However, local sales will not begin in full swing immediately upon the signing of this agreement.

The two companies plan to first conduct DeepCAS’s PoC at major hospitals within the Boao-Lucheng International Medical Tourism Pilot Zone in Hainan Province. The PoC can begin once the hospitals complete their registration following the local administrative approval process. VUNO, Inc. aims to complete registration within six months.

The Boao Lucheng International Medical Tourism Pilot Zone is an area designated by the Chinese government as a special zone for medical tourism. It operates a system that allows medications and medical devices approved overseas to be used within the special zone prior to obtaining formal approval in mainland China. VUNO, Inc. plans to leverage this system to gather user experience and data on DeepCas from local medical institutions.

DeepCARE is a medical AI solution that analyzes the vital signs of patients admitted to general wards to predict the risk of cardiac arrest within 24 hours. It obtained certification under the European Medical Device Regulation (CE-MDR) last year and is currently pursuing adoption and technical validation at medical institutions in Europe, the Middle East, and other regions.

VUNO, Inc. is also aiming to enter Jiangsu Province, China, with “VUNO Med-Fundus AI,” an AI-based medical device that assists in the diagnosis of fundus images.

According to VUNO, Inc., it recently completed the integration of Fundus AI into a chronic disease management platform operated by local medical technology company BioVision and has begun using it at public healthcare institutions in Yangzhou City, Jiangsu Province. The two companies are currently negotiating a contract for the adoption of Fundus AI and plan to begin full-scale sales following local testing.

Fundus AI is an AI medical device that analyzes fundus images to identify the presence or absence of 12 abnormal findings necessary for disease diagnosis. VUNO, Inc. plans to target the demand for AI-assisted image interpretation, focusing on primary care facilities in China where access to ophthalmologists is relatively limited.

Lee Ye-ha, CEO of VUNO, Inc., said, “China is one of the most closely watched markets for medical AI, but the entry path is challenging, so how we design it is crucial.” He added, “In Hainan, we are utilizing the Pilot Zone system to first secure a local evidence base, while in Jiangsu Province, we are taking a two-track approach by integrating with a local platform that is already operational to enter the medical field directly.”