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Product Alerts

COVID-19 Update from Eversense

3/11/2020

As the COVID-19 continues to spread, our thoughts go out to everyone who has been infected or impacted. We hope that you, your family, friends and colleagues are safe and well, and are taking the necessary precautions to keep it that way.

Senseonics is continuously monitoring the situation for potential impacts related to the coronavirus. There is currently no change to product supply due to the COVID-19. We recognize additional precautionary measures are being implemented at healthcare provider offices which may impact your new Eversense sensor insertion and removal. We recommend calling your healthcare provider to confirm any appointments you may have for Eversense procedures before going into the office. The entire Eversense Customer Care team is here to work with you regarding any concerns or questions.

We are committed to helping our Eversense family navigate through this time of uncertainty. During this time of social distancing, we are only a phone call away to support your needs. We can assist you with: 

  • Qualifying for the Patient Access Program (if you’re new to Eversense)
  • Working with your insurance company to appeal any denials
  • Helping you with any questions or how to better use Eversense CGM to meet your diabetes management goals

On behalf of the Eversense team, it is a privilege be a part of your diabetes management program. Please stay safe, and as always, thank you for trusting Eversense. 

Sincerely,

Fran Kaufman

Francine R. Kaufman, M.D.
Chief Medical Officer, Senseonics, Inc.
Distinguished Professor Emerita of Pediatrics
Keck School of Medicine of the University of Southern California
Children’s Hospital Los Angeles

Will the COVID-19 affect how my sensor works?

Although the Eversense sensor has not been tested with this virus, we anticipate no effect on the performance of the Eversense system. However, due to the presence of the virus in your body, your diabetes management may be affected.

Will the COVID-19 affect my diabetes?

Please contact your Health Care Provider for any questions regarding your diabetes. If you are currently sick or become sick, please follow any sick day management guidelines provided by your Health Care Provider, in addition to contacting them.

Do I have to postpone my insertion/removal because of the virus?

Please discuss this with your Health Care Provider - each office will have their own policies during the virus outbreak. While elective procedures are being postponed, that does not necessarily apply to procedures required for ongoing care, such as the insertion and removal of your Eversense Sensor.
Do not be concerned if your sensor remains inserted for more than 90 days - after 90 days the sensor will be dormant but does not require immediate removal since the sensor is made of biocompatible materials.

For HCPs - How long should I wait before inserting/removing a patient’s sensor if they are recovering from the virus?

It is up to the discretion of the HCP to decide but at the recommendation of Senseonics’ Chief Medical Officer, procedures should be delayed until the patient has fully recovered and is well for at least 14 days. Regarding sensor removals, after 90 days the sensor will be dormant but does not require immediate removal (the sensor is made of biocompatible materials).

Cybersecurity Update

3/5/2020

Background

On March 3, 2020, the U.S. Food and Drug Administration announced the potential threat of a set of cybersecurity vulnerabilities, referred to as SweynTooth, that were publicly disclosed in mid-February by security researchers at Singapore University of Technology and Design. These potential vulnerabilities in devices that use Bluetooth Low Energy (BLE) can possibly be exploited and could introduce risk for medical devices. 

Eversense and Eversense XL CGM Systems

The Eversense system is not impacted by the SweynTooth vulnerabilities. The BLE chipset employed in both Eversense and Eversense XL CGM Systems is not part of the group of the affected chipsets published by the FDA.

Our system employs an architectural framework that separates the BLE communication from the ongoing functionality of the device. As a result, even in the event of BLE communication disruption, the device continues to operate normally. As an additional protection, the system also has an on-body vibration glucose alert feature which remains active during any BLE disruptions.

At Senseonics, we take this and all threats to cybersecurity very seriously. We have teams dedicated to maintaining contact with our suppliers and partners across the globe. We will continue to monitor our products and systems to assess any impact associated with cybersecurity issues and take appropriate actions as needed.

We also pledge to continue to proactively provide updates for any security vulnerabilities associated with our products. If you have any questions, please contact us at 1-844-736-7348.