NewNaps' Software for Estimating Stroke Golden Time and Improving Stereopsis Designated as Innovative Medical Device

The Ministry of Food and Drug Safety announced on the 21st that it has designated 'Stroke Onset Time AI,' a brain imaging detection and diagnostic support software developed by NewNaps that estimates the onset time of cerebral infarction, and 'Nu.T,' a cognitive therapy software that improves impaired stereopsis, as the 38th and 39th innovative medical devices, respectively.

Newnaps' brain imaging detection and diagnostic support software 'Stroke Onset Time AI,' designated as the 38th innovative medical device
[Photo by Ministry of Food and Drug Safety]

Stroke Onset Time AI is the first domestic product that uses deep learning-based artificial intelligence (AI) to analyze brain magnetic resonance imaging (MRI) and estimate the probability of whether the golden time for cerebral infarction treatment, approximately 4 hours and 30 minutes, has passed, thereby assisting medical staff in deciding on thrombolytic therapy. It was designated as an innovative medical device in recognition of its technological innovation. The technology estimates the onset time of cerebral infarction by analyzing brain MRI images based on an AI convolutional neural network (CNN) model.

Nu.T is the first domestic product that provides customized visual perceptual learning training through virtual reality (VR) devices to improve impaired stereopsis caused by intermittent exotropia. It was designated as an innovative medical device in recognition of its technological innovation. Specifically, it offers therapy that enhances perceptual ability to stimuli through repetitive training for individuals whose stereopsis?the ability to perceive objects three-dimensionally?is impaired due to intermittent exotropia, a condition where the pupil intermittently deviates outward instead of being centered. This method increases brain plasticity.

An official from the Ministry of Food and Drug Safety stated, "We will continue to strive to promptly provide safe and new treatment technologies to the public through close support such as priority reviews to accelerate the commercialization of innovative medical devices."

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