The company withdrew the FDA 510(k) submission as it looks to instead expedite bringing its next-gen solution to the market.
China-based Sinocare designed the iCan i3 CGM for ease of use, with no scanning, no fingersticks and real-time alerts. It has a 15-day wear life and the company touts a mean absolute relative difference (MARD, an accuracy measurement) of 8.71%. iCan i3 was subject to trademark infringement claims from fellow CGM maker Abbott, but a judge rejected those claims earlier this year.
Sinocare said that, despite satisfying standard CGM performance criteria, it determined that the clinical development program wouldn’t sufficiently demonstrate substantial equivalence to the most recently approved CGMs in the U.S. With an additional study required, the company said it elected to focus on next-generation products.
The company already has CE mark approval for its iCan i6 CGM system in Europe. It now hopes to combine the accuracy and reliability data already demonstrated by i3 with advances in convenience and affordability to continue supporting CGM users around the world.
“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 at Sinocare.
