Sibionics, a Chinese medical technology startup, has secured the CE Mark for its GS1 continuous glucose monitoring (CGM) system, paving the way for its distribution and use in the European market.

The CE Mark, which is also called Conformité Européene or European Conformity, is a certification that affirms a product’s adherence to European Union (EU) health and safety standards, providing evidence of the product’s quality, safety, and effectiveness.

According to Sibionics, the GS1 CGM System is intended to help healthcare professionals as well as patients with the information required for forming informed treatment decisions and for sustaining optimal glucose control.

The system provides users with a 14-day calibration-free continuous glucose monitoring solution, allowing them to transmit glucose data to their monitoring devices or mobile apps and generate professional AGP reports.

Besides, the GS1 CGM supports data sharing with friends and family and is said to seamlessly integrate the advanced ProView remote access platform. This enables healthcare providers to monitor patients remotely and provide timely medical interventions when necessary, aiding in improved diabetes management, said the company.

Sibionics announced that with immediate effect, its GS1 CGM products will be gradually offered for pre-sales in EU nations, the UK, and additional European countries.

The firm stated: “As an innovative MedTech company that combines medical technology with artificial intelligence, Sibionics is committed to extending their innovative and groundbreaking diabetes management technology and expertise to more diabetes patients worldwide.”

Established in 2015, Sibionics has partnered with 1,600 hospitals to incorporate the GS1 CGM into inpatient care, thereby claiming to have benefitted more than 600,000 users worldwide in their diabetes management. The Chinese medical technology firm is said to have an annual production capacity of 6,000,000 units.

Sibionics has developed another product called SiBio KS1 CSM, which is a bio-wearable for metabolic management. KS1 is designed to compute real-time fat-burning rates by analysing ketone levels with an aim to assist individuals with weight management objectives in evaluating their ideal fat-burning condition.