Senseonics receives FDA clearance for one-year CGM - MedTech Dive
Senseonics and Ascensia Diabetes Care received FDA clearance for Eversense 365, the first implantable glucose sensor wearable for a year, doubling the current sensor's wear time. The CGM, implantable under the skin with a removable transmitter, is for adults with Type 1 or Type 2 diabetes and has an integrated CGM designation for automated insulin delivery systems. Senseonics CEO Tim Goodnow anticipates this as a significant catalyst for the company. The sensor requires less frequent calibration and is expected to launch in the fourth quarter, aiming to double sales and user base in 2025.
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Senseonics and Ascensia Diabetes Care received FDA clearance for Eversense 365, the first implantable glucose sensor wearable for a year, doubling the current sensor's wear time. The CGM, implantable under the skin with a removable transmitter, is for adults with Type 1 or Type 2 diabetes and has an integrated CGM designation for automated insulin delivery systems. Senseonics CEO Tim Goodnow anticipates this as a significant catalyst for the company. The sensor requires less frequent calibration and is expected to launch in the fourth quarter, aiming to double sales and user base in 2025.
FDA approves glucose monitor that can be worn for a year.
The FDA has cleared the Eversense 365 CGM for adult patients with type 1 and type 2 diabetes, offering 1 year of use. This long-term, fully-implantable device minimizes life disruption and data interruptions compared to shorter-lasting CGMs. Key features include a tiny sensor, vibration alerts, consistent accuracy, and a removable transmitter. The CGM is also cleared as an integrated system for use with insulin pumps.
Senseonics received FDA clearance for its Eversense 365 CGM system, the world’s first 365-day implantable CGM for type 1 and type 2 diabetes patients aged 18 and older. The system also received iCGM clearance, enabling compatibility with insulin pumps. Ascensia plans to launch Eversense 365 in the U.S. in Q4, aiming for widespread access. Senseonics’ CEO highlights the system’s year-long wear time, accuracy, and user-friendly features, emphasizing its potential to reduce diabetes management burdens.
FDA clears Eversense 365 CGM system for patients 18+ with type 1 or 2 diabetes. This fully-implantable, 365-day sensor sends glucose readings every 5 minutes to a mobile app, offering alerts for high/low glucose levels. It integrates with insulin pumps for automated insulin delivery. Expected availability in Q4 2024.
Senseonics and Ascensia receive FDA approval for Eversense 365, the world's first one-year continuous glucose monitoring system for adults with type I and II diabetes. The fully-implantable sensor lasts 365 days, reducing frequent replacements and interruptions, and offers accuracy, comfort, and discreet alerts. The system also integrates with insulin pumps for automated insulin delivery.