Huinno Aim, a subsidiary of digital healthcare company Huinno, announced on the 20th that its artificial intelligence-based bio-signal analysis software 'Vital-PICASO' was designated as an innovative medical device (No. 113) in the advanced technology group by the Ministry of Food and Drug Safety.
The innovative medical device designation is granted pursuant to the Act on Promotion of the Medical Device Industry and Support for Innovative Medical Devices to products that incorporate advanced technology with high technology intensity and rapid innovation, and thus have a high potential for improved safety or efficacy compared to existing medical devices. Designated products are eligible for institutional benefits, including priority review during the approval process, customized technical consultation, and expedited approval support.
Vital-PICASO is software that analyzes vital sign data from general ward patients using AI to simultaneously predict major clinical deteriorations, such as hypotension, hypoxia, and cardiac arrest. Beyond the traditional focus on predicting severe deterioration, it enables early detection of clinical abnormalities in patients, enabling medical staff to respond quickly. This is expected to contribute to improved patient safety and quality of care, shortening hospital stays by preventing severe deterioration, and reducing medical costs.
A HuinnoAim representative explained, "This designation is a comprehensive recognition of Vital-PICASO's innovation and technological advancement. We are currently conducting clinical trials after receiving Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety. Furthermore, we plan to verify its applicability in the medical field by completing regulatory approval procedures and a new medical technology assessment."
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