[Newyddion Lles]VUNO Med®-DeepCARS, an artificial intelligence-based cardiac arrest prediction medical device from the medical artificial intelligence company Vuno (CEO Lee Ye-ha), is the first in the domestic medical AI industry to be innovative by the US Food and Drug Administration (FDA) designated as a medical device. As a result, it is possible to speed up the FDA approval of ‘Vunomed Deepcas’.
The FDA’s innovative medical device designation is a system designed to help innovative medical technologies that provide the best benefit to patients enter the market faster. Medical devices designated as innovative medical devices will receive priority in the FDA approval process.
In addition, he is known to be able to communicate quickly and smoothly with the FDA in the future approval process, and get close support from the FDA, such as flexible clinical study design and the placement of a professional review team.
‘VUNOMED DEEPCAS’ is an artificial intelligence medical device that scores a patient’s risk of cardiac arrest by analyzing the 4 vital signs, blood pressure, pulse, respiration, and body temperature, which are basically measured in general wards and record them in the EMR (Electronic Medical Record). This enables medical staff to respond pre-emptively in general wards, where it is difficult to constantly monitor all inpatients. According to the results of confirmatory clinical trials, efficacy was demonstrated without specific limitations such as age, sex, and treatment department of patients.
This product has been designated as an innovative medical device by the FDA in recognition of providing the best benefit to patients with innovative diagnostic technology compared to existing severe exacerbation monitoring equipment for life-threatening in-hospital cardiac arrest .
Currently, Vuno is conducting clinical research with local medical institutions to move ‘Vuno Med Deep Cars’ to the US, and last month, it also completed the US patent registration for the core technology involved with the product.
Lee Ye-ha, CEO of VUNOMED, said, “VUNO Med DeepCAS is VUNO’s flagship product in the bio-signal field, and with this designation as an innovative medical device by the FDA, it has once again proven its innovation and ‘to excellence “In this situation, we will strive to increase foreign sales by preparing for rapid approval by the FDA and promoting active local pre-marketing.”
Meanwhile, ‘Vuno Med Deepcas’ was confirmed as an advanced medical technology last year and is an AI medical device that entered the market without insurance for the first time in the domestic medical AI industry It is being used currently active in university and general hospitals.
It was designated as the 6th innovative medical device by the Ministry of Food and Drug Safety in September 2020 and received medical device approval in August 2021 based on the results of large-scale confirmatory clinical trials.