Senseonics, a company based in Germantown, Maryland, won FDA approval for its Eversense continuous glucose monitoring system. This is the first implantable, long term blood sugar monitor that can be used for up to three months at a time.
The technology relies on a small device that’s implanted under the skin of the upper arm. A transmitter is stuck to the skin over the spot where the implant is located, which relies on fluorescence to determine the readings measured by the implant. The transmitter then sends the data, via Bluetooth, to a paired smartphone or smartwatch, which keeps tabs on the patient’s historical blood glucose trends.
“We’re very pleased to receive this FDA approval that allows us to make Eversense available in the United States, as it is in many European markets. With the parallel trends of wearable personal devices and medical implantables for people to manage their health, this product exemplifies the natural evolution for diabetes devices, and Senseonics is excited to help lead the way,” in a statement said Tim Goodnow, President and CEO of Senseonics. “More importantly, we believe the unique features Eversense offers will help open up CGM to millions of people with diabetes who, up to this point, have been hesitant to try CGM despite the clear health benefits it provides.”
“Research has repeatedly demonstrated the clinical benefits patients experience with regular CGM use, including improved glucose control and protection against severe hypoglycemia,” said Steven Edelman, MD, Professor of Medicine at University of California San Diego, Founder & Director of Taking Control of Your Diabetes, and Senseonics Board member. “Despite these benefits, a significant number of people with diabetes do not use, or have access to, continuous glucose monitoring. Furthermore, the data shows that many people who’ve tried traditional CGM in the past either don’t wear it as often as they should or don’t stick with it for a variety of reasons, including concerns surrounding sensor accuracy, sensor insertion, and sensor discomfort. So, it’s important that patients have choices and that medical device companies continue to advance the field of CGM with innovations that make it easier for the end user.”
The system was cleared in Europe just over two years ago.
Here’s a promo video providing a summary of the Eversense system:
Flashback: Eversense 90-day Continuous Glucose Monitor CE Marked in Europe…
Product page: Eversense CGM…
Via: Senseonics…