SiBionics announced today that it received CE mark approval in Europe for its GS1 continuous glucose monitoring (CGM) system.
The company designed its CGM system to provide healthcare providers and patients with data necessary for maintaining glucose control. It offers 14 days of calibration-free continuous glucose monitoring and can transmit data to monitoring devices or mobile applications.
GS1 not only supports data sharing with friends and family but integrates the ProView remote access platform. ProView allows healthcare providers to remotely monitor and provide timely medical interventions.
SiBionics, established in 2015, has a workforce of more than 700 people with more than 40% actively engaged in R&D efforts. The company says its reach includes collaborations with 1,600 hospitals on adopting GS1 and more than 600,000 users of the CGM.
The company can produce 6 million units per year, it said, with each CGM delivering a low MARD value of 8.83%. It also offers a consumer-grade KS1 continuous ketone monitoring biowearable.
“This significant milestone marks a momentous achievement for SiBionics and paves the way for the distribution and utilization of this game-changing technology throughout the European market,” the company said in a news release. “As an innovative medtech company that combines medical technology with artificial intelligence, SiBionics will strive to bring their innovative and groundbreaking diabetes management technology and expertise to more diabetes patients across the globe.