Medical AI company VUNO announced on the 3rd that it has completed the registration of the trademark for its AI-based cardiac arrest prediction medical device, VUNO Med-DeepCARS, in the United States. The company plans to obtain approval from the U.S. Food and Drug Administration (FDA) in the second half of this year and enter the local market.
VUNO Med-DeepCARS was the first medical AI product in Korea to be designated as an innovative medical device by the U.S. FDA. It analyzes four vital signs data?respiration, blood pressure, pulse, and body temperature?of general ward inpatients to predict cardiac arrest within 24 hours. VUNO is conducting clinical research with local U.S. medical institutions to obtain FDA approval for VUNO Med-DeepCARS and has also completed the registration of key technologies related to the product as U.S. patents.
It is also rapidly spreading in the already commercialized domestic medical market. According to the company, as of last month, VUNO Med-DeepCARS has been introduced and billed in 83 hospitals, including 15 tertiary general hospitals. The cumulative number of billed beds has exceeded 33,000. Additionally, demo and purchase procedures are underway at more than 40 other hospitals.
The trademark registration for HARTIV, a chronic disease management brand, has also been completed in the U.S. HARTIV is a healthcare brand consisting of three home medical devices?including the electrocardiogram measuring device HARTIV P30, a blood pressure monitor, and a thermometer?and a health management mobile application. The company plans to prepare for HARTIV’s phased entry into the U.S. market, including obtaining FDA approval for HARTIV P30 by mid-next year.
Lee Ye-ha, CEO of VUNO, said, “From the designation of VUNO Med-DeepCARS as an innovative medical device by the U.S. FDA to local clinical research, technology patents, and trademark registration, preparations for targeting the U.S. market are progressing smoothly. Since domestic and international business strategies tailored to the characteristics of key products, including HARTIV, have been established, we will continue to strive to achieve business results as planned.”
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