Medical AI company JLK (CEO Dongmin Kim) announced that it has completed its sixth application for U.S. Food and Drug Administration (FDA) approval for its medical AI hub platform, achieving its goal for the year.
The product applied for this time is an AI integrated software platform that can handle medical image management and data analysis in one place. It supports analysis and storage of various medical images as well as visualization and mobile communication.
Its strength lies in its ability to manage diverse data generated from medical equipment such as CT, MRI, and ultrasound on a single platform, and its accessibility on mobile devices. Furthermore, it supports both JLK's own solutions and third-party AI solutions, and can be integrated with hospital information systems (HIS) and picture archiving and communication systems (PACS).
Optimized for mobile accessibility, the system allows medical staff to analyze images and update critical findings on mobile devices even when PC access is unavailable. A separate notification function is also integrated, enabling proactive response in emergency situations.
The DICOM standard, with enhanced security and stability, has been implemented, and the viewer function enables precise tasks such as annotation, measurement, and manipulation of medical images. In particular, the integration of various AI modules to view analysis results is expected to significantly improve the work efficiency of medical staff.
JLK CEO Kim Dong-min said, “This FDA-approved product is an innovative software platform that maximizes the efficiency of image management and AI analysis,” and added, “We expect that by utilizing the medical AI hub platform, we will be able to unify AI analysis services within hospitals into a single platform, thereby significantly improving the quality and speed of medical services.”
He also said, “We have achieved all of our annual FDA approval application goals for our entry into the U.S. market,” adding, “We will work to ensure that JLK AI solutions can be used in global medical institutions and successfully complete our expansion into the U.S. market.”
Meanwhile, JLK plans to apply for certification from the US FDA and Japan PMDA for its new stroke solution by 2025, and to make all-out efforts to obtain insurance coverage in the US and Japan.
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