The US FDA has granted approval to the long-term implantable continuous glucose monitor (CGM) for use for up to 6 months, stated Senseonics Holdings.

The Eversense E3 System can be used in adults aged 18 years and above with type 1 or type 2 diabetes. It is implanted subcutaneously into the upper arm under local anesthesia. It enables replacement of finger stick blood glucose measurements and finger sticks may be required along with this system only for calibration, when symptoms do not appear to match the CGM readings, or when the user is taking a tetracycline class drug.

The system was initially approved for use for 90 days in June 2018. In the PROMISE study, presented at the 2021 virtual American Diabetes Association (ADA) Scientific Sessions, the Eversense E3 CGM System was reported to have a mean absolute relative difference (MARD) of 8.5% between clinic reference values and the device′s primary sensor on the basis of nearly 50,000 paired CGM points. In the study, 90% of the sacrificial boronic acid (SBA) sensors lasted 180-day wear, 96% of SBA sensors lasted up to day 90 and day 120, and 94% lasted up to day 150… (Medpage Today)