Sensonics wins FDA approval for Eversense E3 CGM with implantable sensor
Continuous Glucose Monitoring System Manufacturer Sensonics has received FDA approval for its Eversense E3, which can be used to measure glucose levels in adults with diabetes for up to six months.
System It works by using a sensor that is implanted under the skin by a healthcare provider. A transmitter worn on the sensor, above the skin, receives glucose data, provides vibration alerts and transmits the information to a mobile app that can display trends and send alerts via a user’s device.
The CGM is expected to be available to consumers through Sensonics Diabetes Care. Commercialization and distribution partner, starting in the second quarter of this year.
Sensonics has been waiting for this approval for a long time. In December 2020, the company announced that it has received word from the FDA that their The application was delayed due to the COVID-19 pandemic.
The company is flagging this as a benefit for diabetics, who can now use the system for a longer period of time.
“The Eversense E3 CGM System is an exciting advance in diabetes management,” said Dr. Francine Kaufman, Chief Medical Officer of Sensonics, in a statement. “We believe that patients and providers are looking forward to taking this step forward.
“I want to take this opportunity to thank Promise Study To the investigators, study participants and the Sensonics team for helping us reach this important milestone, and the hard work of FDA reviewers in this difficult environment. We are excited to begin making this next generation product available to people with diabetes in the US.”
Everance System First received FDA approval in 2018 Can be used for up to 90 days. In August 2020, Sensonics announced its deal with Ascensia Diabetes Care to manage the distribution of Eversense products for several years, along with an investment in the CGM manufacturer.
In addition to FDA approval, Sensonics also provided a financial update. It expects 2022 net revenue of $14 million to $18 million, with most of its spending going toward R&D and clinical trials for an expanded product pipeline.
Pending Testing Equipment Exemption Approval From the FDA, it plans to begin testing for a sensor that can be used for 365 days.
The company expects fourth quarter revenue of approximately $4 million, and approximately $13.7 million for the full year ended December 31. Sensonics will report its full fourth quarter and fiscal year results next month.
February 15, 2022
