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Eversense NOW Remote Monitoring App for Android Users Receives CE Mark in Europe
Rhea-AI Impact
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Rhea-AI Sentiment
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Rhea-AI Summary
Senseonics Holdings, Inc. (SENS) announced the receipt of the CE mark for its Eversense NOW Remote Monitoring App for Android, enhancing its long-term continuous glucose monitoring system. The app, which offers real-time glucose data monitoring for users and their families, is expected to launch in Q1 2022. The Eversense XL CGM System allows glucose measurement for up to 180 days. The company emphasizes its commitment to transforming diabetes management with innovative technology.
Positive
CE mark approval for Eversense NOW Remote Monitoring App for Android enhances product accessibility.
Eversense NOW app allows remote monitoring, providing peace of mind for users and their families.
Negative
Uncertainties in development and regulatory approval processes may impact future product launches.
Risks associated with the commercial launch and expansion of the Eversense product remain.
- Real-time glucose data and alerts from the world’s first and only long-term CGM system can now be remotely monitored by friends and family of Eversense users on Android and iOS operating system
GERMANTOWN, Md.--(BUSINESS WIRE)--
Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced it received CE mark of the Eversense® NOW Remote Monitoring App for the Android Operating System. The Eversense NOW iOS platform has previously been approved and is currently available in Europe.
“We’re pleased to offer yet another tool for our Eversense users in Europe, now enabling access to this important feature for all our customers,” said Tim Goodnow, PhD, President and CEO of Senseonics. “With the Eversense NOW app, Eversense users can enjoy the added peace of mind that comes with knowing friends and family can remotely view real-time glucose data, see trend graphs, and receive real-time glucose alerts from anywhere.”
The Eversense NOW Remote Monitoring app for the Android operating system is expected to be available starting in the first quarter of 2022 on the Google Play™ Store.
About Eversense
The Eversense® XL Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels in persons age 18 and older with diabetes for up to 180 days. The system is intended to complement, not replace, fingerstick blood glucose (BG) measurements for diabetes treatment decisions. The sensor insertion and removal procedures are performed by a health care provider. The Eversense XL CGM System is a prescription device; patients should talk to their health care provider to learn more. For important safety information, see https://global.eversensediabetes.com/safety-info/.
About Senseonics
Senseonics Holdings, Inc. is a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics' CGM systems, Eversense® and Eversense® XL, include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for Senseonics, including the availability and market acceptance of the Eversense NOW Remote Monitoring app, and other statements containing the words “believe,” “expect,” “intend,” “may,” “projects,” “will,” “planned,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties in the development and regulatory approval processes and timing for the 180-day Eversense product, uncertainties inherent in the commercial launch and commercial expansion of the Eversense product, uncertainties inherent in the transition of commercialization responsibilities to Ascensia Diabetes Care, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties in the duration and severity of the COVID-19 pandemic, and such other factors as are set forth in the risk factors detailed in Senseonics’ Annual Report on Form 10-K for the year ended December 31, 2020, Senseonics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 and Senseonics’ other filings with the SEC under the heading “Risk Factors.” In addition, the forward-looking statements included in this press release represent Senseonics’ views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics’ views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics’ views as of any date subsequent to the date hereof.
