Sinocare Voluntarily Withdraws FDA iCGM Application for its First Generation iCan i3 System

On July 28, 2025, Sinocare Inc. [SZ300298] confirmed withdrawal of the first generation iCan i3 System 510(K) application. This strategic decision was taken with a view to expediting the delivery of their next generation solution to the US market.

Despite satisfying all eleven iCGM standard performance criteria as analyzed, the agreed i3 clinical development program was considered insufficiently powered to show substantial equivalence to the most recently approved iCGM product. Therefore, with an additional study required, it was decided to focus on next generation products.

Sinocare continually addresses the needs of people living with diabetes. Having achieved MDR-CE certification for their iCan i6 CGM System in Europe, they are now focused on combining the high accuracy and reliability data already demonstrated by the i3 system with advances in convenience and affordability, to continue supporting CGM users globally.

“We believe the enhanced usability and convenience seen in the next generation iCan System offers greater comparability to existing market leaders in the US. Revising our approach to the regulatory process will allow us to demonstrate alignment to the most recent FDA equivalence guidance through our latest clinical development program.” Jiangfeng Fei, Head of CGM Global

About Sinocare Inc.

Sinocare is the largest manufacturer of glucose monitoring devices in Asia. Founded in 2002, Sinocare Inc. was the first blood glucose meter company to be listed in China. With a commercial presence in Asia, Europe and North America, Sinocare has expanded internationally through partnerships and acquisitions such as the USA based PTS Diagnostics Inc., Nipro Diagnostic Inc., now known as Trividia Health Inc. Its dedication to innovation in biosensing technology has helped Sinocare become the global 4th largest blood glucose meter manufacturer and one of the leading diabetes management companies worldwide.

About Sinocare iCan™️ CGM System

Sinocare iCan CGM System is one of the most widely clinically studied continuous glucose monitoring systems in the world. [1, 2, 3, 4, 5]

More than 500 people with type 1 and type 2 diabetes have been involved in our world-wide clinical studies, and most clinical study participants have been assessed in sites in either the United States of America or in the Federal Republic of Germany.                         

Approximately 60.95% of 507 worldwide iCan CGM system clinical study subjects are people living with diabetes in either the USA or in Germany.

iCan CGM clinical study citations

1. Enrolment n=159 https://clinicaltrials.gov/study/NCT05806554 a completed study in adults.

2. Enrolment n=134 https://clinicaltrials.gov/study/NCT05908448 a completed study in children.

3. Enrolment n=78 https://clinicaltrials.gov/study/NCT06570551 a completed study in children.

4. Enrolment n=16 https://clinicaltrials.gov/study/NCT05348928 a completed study in adults.

5. Enrolment n=120 https://clinicaltrials.gov/study/NCT05995756 a completed study in adults.

For more inquiries, please contact:

Sinocare Inc. Investor Relations Office

Email: investor@sinocare.com 

Phone: +86 0731-89935529

Website: www.sinocare.com