Osang Healthcare Preparing to Launch Next-Generation Diabetes Diagnostic Multi-Analyzer 'CLOVER DX D1'

Osang Healthcare announced on May 18 that it is currently conducting clinical trials and regulatory approval procedures for its next-generation diabetes diagnostic multi-analyzer, the "CLOVER DX D1," which has the potential to achieve a quantum leap in the glycated hemoglobin analyzer market.

This product is a comprehensive device capable of simultaneously measuring various biomarkers, including glycated hemoglobin (HbA1c), albumin/creatinine ratio (ACR), and C-reactive protein (CRP). The company aims to obtain CE-IVDR (European In Vitro Diagnostic Medical Devices Regulation) and U.S. Food and Drug Administration (FDA) 510(k) certification, as well as the Clinical Laboratory Improvement Amendments (CLIA) Waiver in the United States.

The "CLOVER DX D1" is an all-in-one system that allows for rapid and accurate measurement of a wide range of biomarkers using a single device, based on a user-friendly testing process and automation features. In addition to blood glucose management, it enables comprehensive monitoring of kidney function and inflammation status, which is expected to help predict the risk of developing diabetes and enable early diagnosis of complications.

A company representative stated, "CLOVER DX D1 is an essential next-generation product that goes beyond single diabetes testing devices to provide integrated management of diabetes and its complications. Based on its performance and price competitiveness, we plan to expand collaboration with global medical device companies, accelerate entry into major markets such as the United States, and pursue both revenue growth and improved profitability."

This content was produced with the assistance of AI translation services.