Senseonics, a company headquartered in Germantown, Maryland, won European regulatory clearance to introduce its Eversense continuous glucose monitoring system. The system includes a sensor that is implanted under the skin and swapped out for a new one every three months, and a transmitter that communicates with a matching smartphone app to provide the results.
The sensor is the actual glucometer that continuously samples blood passing by it using fluorescence technology. The transmitter read the sensor state and uses Bluetooth wireless connectivity to pass data to the smartphone app. The app in turn has features such as alarms when sugar levels fall out of bounds and historical tracking for easy sharing with the physician.
The previously presented multi-center European PRECISE pivotal trial showed strong accuracy and safety results throughout the 90 day use of the Eversense CGM System.
CE Mark confirms that the product meets the Essential Requirements of the Active Implantable Medical Device Directive (AIMDD 90/385/EEC). The system is indicated for continually measuring interstitial fluid glucose levels in adults and to be used as an adjunctive device; to complement information obtained from standard home blood glucose meters. In conjunction with the CE Mark approval, Senseonics will conduct post market surveillance activities which will include gathering long-term safety and performance data from repeated sensor insertions.
Link: Senseonics homepage…