Software Using AI to Detect Abnormal Findings on the Inner Eye Recognized as the First Innovative Medical Device

VUNO's Fundus Image Analysis Medical Imaging Diagnostic Support Software

[Asia Economy Reporter Choi Dae-yeol] Vuno, a medical device company that analyzes images of the inner surface of the eye using artificial intelligence (AI) technology, has had its medical imaging diagnostic support software recognized as an innovative medical device. This is the first designation since the government established the innovative medical device system. Dawon Medax's cancer treatment device was also recognized as the second innovative medical device.

The Ministry of Food and Drug Safety announced two innovative medical devices designated in accordance with relevant laws and procedures. Innovative medical devices refer to medical devices that apply advanced technologies such as information and communication technology, biotechnology, or nanotechnology, and have improved or are expected to improve safety and efficacy compared to existing medical devices or treatments.

Vuno's software is medical imaging diagnostic support software that analyzes images of the inner eye. Using AI, it analyzes images of the retina at the back of the eye to examine more than 12 abnormal findings such as vascular abnormalities. It is already approved as a medical device. Dawon Medax's neutron irradiation device under development for treatment utilizes the characteristic of cancer cells capturing boron. After injecting boron into cancer cells, neutrons generated by a particle accelerator are irradiated; the boron reacts with the neutrons to destroy the cancer cells. It is being developed to selectively eliminate cancer cells.

Even if designated as an innovative medical device, approval as a medical device based on safety and efficacy standards must be obtained after development is completed. Lee Eui-kyung, Commissioner of the MFDS, said, "This designation of innovative medical devices will be the beginning of full support for development and commercialization," and added, "We will support innovative medical devices to be rapidly commercialized and gain market competitiveness."

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