Senseonics' Eversense 365, the First One-Year CGM, Receives FDA Approval
核心洞察
Senseonics (搜索) and Ascensia Diabetes Care (搜索) received FDA approval for Eversense 365 (搜索), the first continuous glucose monitoring (CGM) system offering a full year of use.
Eversense 365 (搜索) is a fully implantable device for adults with type 1 and type 2 diabetes (搜索), minimizing life disruption compared to short-term CGMs.
The system is designated as an integrated CGM (iCGM), allowing integration with insulin pumps for automated insulin delivery, enhancing diabetes (搜索) management.
Senseonics (搜索) Holdings and Ascensia Diabetes Care (搜索) have announced FDA approval for the Eversense 365 (搜索) Continuous Glucose Monitoring (CGM) system, the first of its kind to offer a fully implantable sensor lasting a full year. This innovative system is designed for individuals aged 18 and older with type 1 and type 2 diabetes (搜索), promising to significantly reduce the burden of frequent sensor changes associated with traditional CGMs.
The Eversense 365 (搜索) system distinguishes itself through its long-term sensor, which remains fully implanted for 365 days, contrasting sharply with the 10-14 day sensor replacement schedule of short-term CGMs. This extended longevity aims to minimize data interruptions caused by sensor failures or the need for frequent changes.
Key Features and Benefits
The Eversense 365 (搜索) boasts several features designed to improve the user experience:
- Extended Wear Time: The one-year sensor eliminates the need for frequent replacements.
- Reduced False Alerts: Designed to minimize false alerts from compression lows during sleep.
- Removable Transmitter: The transmitter can be taken on and off without sensor wastage or warm-up periods.
- On-Body Vibration Alerts: Discreet alerts notify patients even when their mobile phone is out of sight.
According to Senseonics (搜索), the system's design ensures the sensor remains securely under the skin, reducing the likelihood of it being dislodged and minimizing replacement costs. The system also incorporates a gentle, silicone-based adhesive that can be changed daily to maximize comfort and minimize skin reactions.
Integrated CGM (iCGM) Designation
The FDA has cleared Eversense 365 (搜索) as an integrated CGM (iCGM) system, allowing it to be integrated with compatible medical devices, including insulin pumps for automated insulin delivery (AID) systems. Senseonics (搜索) is currently in discussions with various pump manufacturers to explore partnership opportunities.
"The approval of Eversense 365 (搜索) represents a significant leap in CGM innovation," said Dr. Tim Goodnow, president and CEO of Senseonics (搜索). "Extending sensor longevity to a full year, coupled with seamless device connectivity and a high level of accuracy, provides both freedom and peace of mind to patients living with diabetes (搜索)."
Commercial Launch and Future Integration
Ascensia Diabetes Care (搜索) anticipates launching Eversense 365 (搜索) in the US in the fourth quarter of 2024 and is working to ensure broad coverage availability. Brian Hansen, president of CGM at Ascensia Diabetes Care, noted, "Eversense 365 allows people with diabetes (搜索) to focus on living their lives, rather than managing the limitations that many experience with short-term CGMs."
The company is also focused on leveraging the unique potential of Eversense 365 (搜索) to simplify life with integrated AID systems, with ongoing partnership discussions with pump manufacturers.