Senseonics wins CE mark approval for 180-day Eversense E3 CGM

The Eversense E3 system. [Image from Ascensia/Senseonics]Senseonics (NYSE:SENS) announced today that it received CE mark for the next-generation Eversense E3 CGM system.

Germantown, Maryland-based Senseonics offered its previous-generation continuous glucose monitor (CGM) with a 90-day wear time. Its next-generation Eversense E3 can be used for up to six months (180 days).

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Senseonics beats The Street in Q1 following Eversense E3 launch

The Eversense E3 system. [Image from Ascensia/Senseonics]Senseonics (NYSE:SENS) posted first-quarter results that topped the consensus revenue forecast on Wall Street.

The Germantown, Maryland-based company posted profits of $86.7 million, or 19¢ per share, on sales of $2.5 million for the three months ended March 31, 2022, for a massive bottom-line gain from losses of $249.5 million this time last year despite a sales decline of 12.8%.

Adjusted to exclude one-time items, losses per share were 3¢, falling level with projections on Wall Street, where analysts were looking for sales of $2.2 million.

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Senseonics announces first Eversense E3 CGM implant in U.S.

The Eversense E3 system. [Image from Ascensia/Senseonics]Senseonics (NYSE:SENS) announced today that the first patient was implanted with its next-generation Eversense E3 continuous glucose monitor.

Germantown, Maryland-based Senseonics, in partnership with Ascensia Diabetes Care, launched the Eversense E3 long-term implantable CGM system in the U.S. earlier this week. The system received FDA approval in February for use lasting up to six months (180 days), making it the longest-lasting CGM sensor available in the U.S.

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Ascensia launches Senseonics’ next-gen 180-day Eversense E3 CGM in U.S.

The Eversense E3 system. [Image from Ascensia/Senseonics]Ascensia Diabetes Care announced today that it launched the Senseonics (NYSE:SENS) Eversense E3 system in the U.S.

The next-generation Eversense E3 continuous glucose monitoring (CGM) system, developed by Germantown, Maryland-based Senseonics, received FDA approval in February for use lasting up to six months (180 days), making it the longest-lasting CGM sensor available in the U.S.

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Diabetes tech is off to a hot start in 2022

Diabetes technology developers have high hopes for the year ahead, some of which have already come to fruition.

Change is continuous in continuous glucose monitoring (GCM), with expanded wear-times, improved accuracy and more. Meanwhile, never-ending innovation in insulin delivery is delivering wearable patches and closedloop delivery systems, making insulin management easier for people with diabetes.

Expectations were already high for new technology coming out of the diabetes space, and significant improvements last year only lifted those hopes higher. Let’s check in with a few companies promising big steps forward, including some that have already made significant progress.

Get the full story at our sister site, Drug Delivery Business News.

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Diabetes tech is off to a hot start in 2022

Diabetes technology developers have high hopes for the year ahead, some of which have already come to fruition.

Change is continuous in continuous glucose monitoring (GCM), with expanded wear-times, improved accuracy and more. Meanwhile, never-ending innovation in insulin delivery is delivering wearable patches and closedloop delivery systems, making insulin management easier for people with diabetes.

Expectations were already high for new technology coming out of the diabetes space, and significant improvements last year only lifted those hopes higher. Let’s check in with a few companies promising big steps forward, including some that have already made significant progress.

Get the full story at our sister site, Drug Delivery Business News.

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Senseonics ticks up on Q4 earnings beat

Senseonics’ Eversense continuous glucose monitor. (Image from Senseonics)

Senseonics (NYSE:SENS) shares ticked up today on fourth-quarter results that came in ahead of the consensus forecast.

The Germantown, Maryland-based company posted revenues of $4 million for the three months ended Dec. 31, 2021, representing sales growth of 2.6% from the same period in 2020.

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Ascensia launches Senseonics’ remote monitoring app for Android devices in Europe

Ascensia Diabetes Care announced today that it launched Senseonics‘ (NYSE:SENS) Eversense NOW remote monitoring app for Androids in Europe.

The launch makes remote monitoring capabilities for all of Senseonics Eversense and Eversense XL continuous glucose monitoring (CGM) users on Android and iOS operating systems in the U.S. and Europe, respectively.

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Senseonics wins FDA approval for next-generation Eversense 180-day CGM, provides 2022 outlook

Senseonics’ Eversense continuous glucose monitor. (Image from Senseonics)

Senseonics (NYSE:SENS) announced today that the FDA granted approval to its next-generation continuous glucose monitor system.

Germantown, Maryland-based Senseonics designed the Eversense E3, which includes proprietary sacrificial boronic acid (SBA) technology, to extend longevity to six months (180 days), having previously offered the system with a 90-day wear time.

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With FDA clearance ‘imminent’ for Senseonics 180-day CGM, what’s next?

Senseonics’ Eversense continuous glucose monitor. (Image from Senseonics)

When Dr. Fran Kaufman began her career in the late 1970s, diabetes management consisted of urine testing and animal insulin.

At that point, it had not been proven that managing glucose actually mattered, according to Kaufman, and proof didn’t come until 1992 with the conclusion of the DCCT study.

“I’ve seen a lot of innovation,” said Kaufman, chief medical officer at continuous glucose monitoring technology developer Senseonics (NYSE:SENS).

She’s been involved in innovation as well, the latest being the 180-day Senseonics Eversense continuous glucose monitor (CGM), for which FDA approval could be coming very soon.

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Senseonics expects FDA approval for next-gen 180-day CGM in ‘coming weeks’

Senseonics’ Eversense continuous glucose monitor. (Image from Senseonics)

Senseonics (NYSE:SENS) announced that it anticipates a decision from the FDA regarding the approval of its new CGM system within weeks.

The company is seeking a premarket approval supplement for the next-generation Eversense 180-day implantable continuous glucose monitoring (CGM) system. Data presented earlier this year demonstrated strong accuracy, with the next-generation Eversense matching performance levels compared to the current 90-day sensor available in the U.S., but with reduced calibration, down to one per day, with the duration extended to 180 days.

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Senseonics wins CE mark for remote glucose monitoring app for Android users

Senseonics’ Eversense continuous glucose monitor won FDA CLEARANCE/APPROVAL earlier this year. (Image from Senseonics)

Senseonics (NYSE:SENS) announced today that its Eversense NOW remote monitoring app for Android received CE mark approval.

Germantown, Maryland-based Senseonics already received such approval for the Eversense NOW iOS platform and can now offer it in Europe on the Android operating system. The company expects to make the Eversense NOW remote monitoring app for Android available in the first quarter of 2022 on the Google Play Store.

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