i-SENS’ CareSens Air continuous glucose monitoring system became the first CGM device to meet proposed European clinical performance criteria, according to a pooled analysis published in Diabetes Therapy. The company reported that the system satisfied the accuracy standards under the framework used to evaluate clinical performance. For manufacturers, achieving formal alignment with proposed criteria can reduce uncertainty for future submissions and reimbursement discussions across European markets. For clinicians, the update supports evidence-based selection when comparing CGM performance claims under region-specific expectations.