MyHerb's 'MyLink' Receives FDA Approval

MyHub (CEO Yang Hyuk) announced on the 7th that its medical AI integrated platform, maiLink, has received 510(k) approval, a premarket approval for medical devices, from the U.S. Food and Drug Administration (FDA). This approval corresponds to a Class II medical device in the medical image management and processing system field.

With this FDA approval, MyLink has secured its third global medical device certification, following certification from the Malaysian Medical Devices Authority (MDA) and registration with the Indonesian Food and Drugs Agency (BPOM). Building on this, MyHerb plans to expand its business into the US market and Central and South America.

MyLink is an integrated medical AI platform that integrates major domestic and international AI-based medical diagnostic assistance solutions into a single platform, enabling medical professionals to select and utilize the appropriate AI solution based on their clinical environment and purpose.

It is designed to operate various AI solutions on a single platform while minimizing changes to the existing hospital IT infrastructure by applying a hybrid installation method that combines an on-premise platform server based on a mini PC and a cloud AI server.

Additionally, it provides AI-based analysis results-based diagnostic report writing assistance and automatic patient report generation, reducing the workload for medical staff and helping patients more easily understand their health information. This provides practical value to both medical staff and patients in real-world clinical settings.

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