iXensor Co., Ltd. Receives FDA 510(k) Clearance for a Meter-Free Smartphone- Based PixoTest ® Blood Glucose Monitoring System.

The First Blood Glucose Monitoring System Using the Front Camera of Smartphones and App Algorithm to Analyze Blood Glucose Level.

Mobile health leader iXensor announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) class II clearance for their innovative smartphone-based PixoTest ® Blood Glucose Monitoring System.

“This FDA clearance is a significant milestone for iXensor,” said Alan Tsai, iXensor CEO. “Integrating Smartphones with IVD tests is challenging. FDA 510(k) class II is a higher level to achieve. We’re proud that PixoTest ® Blood Glucose Monitoring System is now being approved. It’s a stimulation for our following development.”

The US patent granted PixoTest ® technology utilizes the lighting and image sensing module of the smartphone (or mobile device) to detect the color change reaction on the biochemical test strip. The image of the test strip is captured by the front camera of the smartphone and analyzed via the measurement algorithm to turn out a quantified or semi- quantified result. IDT (Institute of Diabetes- Technology) report has shown that PixoTest Blood Glucose Monitoring System got 98.17% accuracy, which meets the requirement of ISO 15197:2013.

“PixoTest ® technology helps bring ‘Mobile Health’ into reality,” said Jerry Chen, iXensor CMO. “It allows people to manage their health at home and anywhere simply with their smartphone. It will raise patient compliance.”

This PixoTest® sensing methodology can also be applied to different biomarker measurements. Along with PixoTest ® Blood Glucose Monitoring System, iXensor has applied the PixoTest ® technology to various measurements including HbAlc, Lipid panels, and LH (ovulation hormone), providing an advanced mobile health solution to simplify the testing process and the way of health management. iXensor plans to continue expanding upon this platform.