Medical AI JLK (CEO Dongmin Kim) has obtained 510(k) approval from the U.S. Food and Drug Administration (FDA) for its medical AI integrated platform, laying the foundation for full-scale entry into the U.S. market.
The product that has received FDA approval is an AI integrated software platform that can handle medical image management and data analysis in one place, and supports analysis and storage of various medical images as well as visualization and mobile communication.
This platform features increased convenience for medical staff by integrating various AI modules to check analysis results and directly update important findings. The DICOM standard with enhanced security and stability has been applied, and the viewer function allows precise work such as annotation, measurement, and manipulation of medical images.
In particular, it was built as an all-in-one system that allows users to check the analysis results synthesized by various artificial intelligence modules through an independent viewer and receive mobile notifications. JLK is expected to supply to U.S. hospitals as a comprehensive platform that can integrate and operate various analysis solutions such as CT, CTA, CTP, and MRI that have acquired FDA approval to improve the current stroke workflow.
JLK is pursuing a strategy to dramatically reduce maintenance costs and maximize profits through solution integration. This is because by integrating medical AI systems that were previously provided as individual solutions into a single platform, the management burden on hospitals can be reduced, and profitability can be maximized from the company's perspective. In addition, it is emphasizing its strengths in maximizing usability, such as the function of linking with mobile platforms to immediately notify AI results.
With this approval, JLK has secured a total of six FDA approvals. The industry is paying attention to JLK’s strategy of obtaining multiple approvals in a short period of time, and is evaluating that it has dispelled concerns over the recent personnel reduction at the US FDA.
“The medical AI integrated platform that received FDA 510(k) approval this time is a medical imaging platform optimized for local U.S. hospitals managing a large number of patients,” said JLK CEO Dongmin Kim. “By providing a mobile version, we have maximized usability in emergency situations, and with the analysis results synthesized by various artificial intelligence modules, we expect to significantly improve hospital workflow as well as increase medical staff satisfaction.”
He also said, “We will focus on activities to secure sales as the FDA approval process for our entry into the U.S. market is progressing smoothly,” adding, “We will work to ensure that JLK AI solutions can be used in global medical institutions and achieve our goal of generating sales in the U.S. within the year.”
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