VUNO Inc., a medical artificial intelligence (AI) company in South Korea, announced on Tuesday that its retinal image analysis aid solution has successfully passed the comprehensive evaluation and assessment by the Ministry of Food and Drug Safety (MFDS) for innovative medical devices.

According to the company, the solution, VUNO Med-Fundus AI, utilizes AI to analyze images of the posterior segment of the eye, known as the ocular fundus, to rapidly detect abnormalities and lesions related to major vision-threatening diseases such as diabetic retinopathy, macular degeneration, and glaucoma.

The device can provide diagnostic results within seconds. This product had already been designated as the first innovative medical device to receive support from the MFDS even before its commercial release.

With the completion of the evaluation, the device is now permitted for non-reimbursable use in medical settings for the next 3 to 5 years. The company plans to pursue formal inclusion in health insurance coverage in the future.

VUNO also aims to establish real-world usage data through on-site utilization, while strengthening domestic sales and marketing efforts.

“With this decision, the path for the official inclusion of VUNO Med-Fundus AI in health insurance has been opened,” the company said. “We have demonstrated excellent clinical efficacy through numerous research papers published in global academic journals.”

By Pulse

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