| Developers: | Senseonics Holdings |
| Last Release Date: | June 2018 |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Content |
Main article: Diabetes mellitus
2022: Announcement of a glucose monitoring system that has been running continuously for 180 days
On June 16, 2022, Senseonics launched Eversense E3 CGM glucose monitoring system, which operates continuously for 180 days. The device of the previous generation worked only 90 days.
In Europe, the Senseonics CGM system, designed for 180 days of Eversense XL, was already available, but the next-generation Eversense E3 has a number of improvements over XL, including reduced calibrations, increased survivability and non-conjunctive use, meaning no sticks are needed to make a dosage decision.
For June 2022, Eversense E3 is approved in Europe, and in February 2022 received approval from the US Food and Drug Administration. Ascensia Diabetes Care, a global commercial partner of Senseonics, introduced the system in the U.S. on April 4, 2022, and the same week the first patient received an E3 implant.
Ascensia will make the Eversense E3 available in Europe from the third quarter of 2022, according to a press release. The device will be distributed to, Germany, Italy(Spain including),,, Andorra ,, and. Netherlands To Poland Switzerland Norway Sweden
Senseonics developed the Eversense E3 using patented boronic acid technology. The technology increases the durability of the sensor and makes the device, according to the developers, the most durable CGM system. The sensor is fully implantable and requires just two sensor installation and removal procedures per year.
The system also includes a detachable smart transmitter that attaches in place with a silicone-based soft glue, providing subtle vibration signals on the body and transmitting data to a mobile application where users can view glucose values, trends and warnings.[1]
2018: Start of sales
In June 2018, sales of a continuous glucose monitoring system with a fully implantable sensor, Eversense, were announced. It is intended for use by people aged 18 and over who have diabetes. The sensor, according to Senseonics Holdings (product developer), can stay in the body for up to 90 days.
Eversense's continuous glucose monitoring system uses a small sensor that is implanted under the skin by a health care professional during an outpatient procedure. It is coated with a fluorescent chemical, which, when exposed to blood glucose, emits some photons, and the radiation force is measured by a sensor. Every five minutes, measurement data is sent to an app on a smartphone or tablet that alerts users to critically elevated or reduced blood sugar levels.
The evidence base for the effectiveness of the new device is presented by data from a clinical study conducted among 125 adult patients with diabetes mellitus. The effectiveness of the device was evaluated by comparing the Eversense system readings with the data obtained using a laboratory glucose analyzer. In addition, the studies evaluated the safety of the system.
It is believed that the new technology will allow patients to more effectively control the state of their health. The entry into the market of digital devices of this quality gives patients the opportunity to effectively manage the course of chronic diseases, including diabetes. Eversense implantable sensors reflect the potential of such mobile platforms, and in the meantime, US regulators are preparing a new and more carefully developed approach to controlling the quality of software products, including mobile medical applications.[2]
Notes
| The site content is translated by machine translation software powered by PROMT. The machine-translated articles are not always perfect and may contain errors in vocabulary, syntax or grammar. Read original article If you find inaccuracies or errors in the results of machine translation, please write to editor@tadviser.ru. We will make every effort to correct them as soon as possible. |