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Data supports safety and accuracy of Senseonics 365-day CGM

The Eversense E3 system. [Image from Ascensia/Senseonics]Senseonics (NYSE: SENS) today announced positive clinical data highlighting the effectiveness of its Eversense continuous glucose monitor (CGM).

Germantown, Maryland–based Senseonics presented two studies on its latest-generation Eversense E3 at the American Diabetes Association 83rd Scientific Session. The 180-day implantable CGM received FDA approval in February of last year. The sensor is fully implantable and requires just two sensor insertion and removal procedures per year.

Senseonics’ latest data includes evidence supporting even longer wear time, plus more positive results for the existing platform.

“These data further bolster Eversense’s position as a leading CGM choice for people with diabetes,” said Dr. Francine Kaufman, Senseonics chief medical officer.

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

UnitedHealthcare to cover Senseonics Eversense E3 CGM

The Eversense E3 system. [Image from Ascensia/Senseonics]Senseonics (NYSE:SENS) announced that UnitedHealthcare intends to begin providing coverage for its Eversense E3 CGM.

Coverage of the continuous glucose monitor for people with type 1 and insulin-requiring type 2 diabetes goes into effect on July 1, 2023. UnitedHealthcare, the largest health insurance company in the U.S., covers more than 45 million lives. Its offerings include health benefits, affordable coverage, a simplified healthcare experience and access to high-quality care.

Germantown, Maryland-based Senseonics designed its next-generation Eversense E3 CGM for long-term monitoring. The 180-day implantable CGM received FDA approval in February of last year.

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

Senseonics stock rises after hours on Street-beating Q1

Senseonics (NYSE:SENS) shares ticked up after hours on first-quarter results that topped the consensus forecast.

Shares of SENS rose 1.9% at 66¢ apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day down 0.4%.

The Germantown, Maryland-based company posted profits of $1.3 million. Earnings per share broke even at $0.00 on sales of $4.1 million for the three months ended March 31, 2023.

Earnings per share topped Wall Street estimates by 3¢. Sales also came out ahead of expectations of $3.4 million.

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

Ascensia expands payment program for Senseonics Eversense E3 CGM

The Eversense E3 system. [Image from Ascensia/Senseonics]Ascensia Diabetes Care announced today that it expanded the Eversense PASS program for the Senseonics (NYSE:SENS) Eversense E3 CGM.

Eversense PASS, a payment assistance and simple savings program, aims to enhance affordability and access to Eversense E3. Ascensia serves as the global commercial partner for Senseonics. The Senseonics continuous glucose monitor (CGM), a 180-day implantable CGM, received FDA approval in February of last year.

It features a third-generation sensor with SBA technology that enhances sensor longevity. This makes it — according to Senseonics — the longest-lasting CGM system. The fully implantable sensor requires just two insertion and removal procedures per year.

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

Senseonics projects more than 20% growth in 2023

The Eversense E3 system. [Image from Ascensia/Senseonics]Senseonics (NYSE:SENS) shares ticked up after hours today on fourth-quarter results that beat the consensus forecast.

Shares of SENS rose 1.7% at 96¢ apiece after the market closed. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day up 1.7%.

The Germantown, Maryland-based long-term implantable CGM maker posted profits of $11.6 million in the quarter. That amounts to 2¢ per share on sales of $5.6 million for the three months ended Dec. 31, 2022.

Senseonics posted an 86.9% bottom-line slide on sales growth of 40%. Its EPS topped Wall Street estimates of breakeven, while revenues beat projections of $4 million.

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

What to expect in diabetes care in 2023

[Image courtesy of Walmart]

After a banner year for diabetes technology in 2022, there’s still plenty to look forward to in 2023.

Throughout 2022, we saw a wide range of advancements in diabetes technology. We saw launches for next-generation technologies, exciting clinical trial results, and rumored spinouts and acquisitions.

You can read all about the biggest diabetes stories of 2022 here.

There’s plenty to look forward to in the diabetes space in the months ahead. Here are a few things worth keeping an eye on.

CMS decision could benefit CGMs

In October, The Centers for Medicare and Medicaid Services (CMS) published a new local coverage determination (LCD). That LCD modified coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.

Analysts suggested at the time …

The year ahead in diabetes care: what to expect in 2023

[Image courtesy of Walmart] After a banner year for diabetes technology in 2022, there’s still plenty to look forward to in 2023.

Throughout 2022, we saw a wide range of advancements in diabetes technology. We saw launches for next-generation technologies, exciting clinical trial results, rumored spinouts and acquisitions and more.

You can read all about the biggest diabetes stories of 2022 here.

As we embark on a new year in 2023, there’s still plenty to look forward to in the diabetes space. Here are a few things worth keeping an eye on.

CMS decision could benefit CGMs

In October, The Centers for Medicare and Medicaid Services (CMS) published a new local coverage determination (LCD). That LCD modified coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.

Analysts suggested at the time that the decision marked a win for …

The 10 biggest diabetes tech stories from 2022

Some of the biggest diabetes technology developments in 2022. These include the Dexcom G7 (top left), Insulet Omnipod 5 (bottom left), Senseonics Eversense E3 (top right) and Abbott FreeStyle Libre 3 (bottom right. 2022 represented a landmark year for next-generation diabetes technologies. Here are the biggest stories from the past year.

Some companies picked up major regulatory nods. Others experienced major regulatory setbacks.

Partnerships were formed and ended, while mergers and acquisitions came and went. There were many stories to choose from, but here are 10 big ones that stood out:

Dexcom G7 receives FDA clearance

The long-awaited regulatory nod for Dexcom’s next-generation continuous glucose monitor (CGM) finally came in December.

Some suggested that San Diego-based Dexcom may pick up clearance as soon as summer 2022. However, a software change recommended by the FDA, plus COVID-19-related backlog, delayed proceedings.

Dexcom COO Ja…

DeviceTalkers assemble for the final Newsmakers of 2022

In this episode, your diligent team of DeviceTalkers assembled to review our Top 10 events, trends and newsmakers of 2022.

Executive Editor Chris Newmarker, Pharma Editor Brian Buntz, Managing Editor Jim Hammerand, Senior Editor Danielle Kirsh and Associate Editor Sean Whooley joined me, DeviceTalks Editorial Director Tom Salemi, for the latest DeviceTalks podcast.

We’ve got some highs — robots, diabetes — and some lows — supply chain, recalls — and a whole lot of interesting things in between. All-in-all, we’re bullish on what’s to come in 2023! And we only mentioned COVID-19 once.

Companies mentioned in our wide-ranging discussion include Abbott, Abiomed, Ambu, Becton Dickinson, Boston Scientific, CMR Surgical, Dexcom, embecta, Intuitive, Johnson & Johnson Medtech, Medtronic, Neuralink, Philips, Senseonics, Stryker, Synchron, Vicarious Surgical, Zimmer Biomet, ZimVie and many more.

You can listen to other DeviceTalks Podcast Network shows at…

Ascensia Diabetes integrates its Eversense CGM with Apple Health

The Eversense E3 system. [Image from Ascensia/Senseonics]Ascensia Diabetes Care announced today that it has updated its Eversense Continuous Glucose Monitoring system app to integrate with Apple Health.

The Parsippany, N.J.-based company makes the Contour Blood Glucose Monitoring (BGM) system and distributes Senseonics’ Eversense CGM system. The new Apple Health integration will allow people with diabetes using Senseonics’ Eversense CGM systems to view glucose data within the Apple Health app. In addition, they can also see other health metrics on the iPhone’s health and wellbeing platform.

Eversense CGM is a fully-implantable CGM with a sensor that has a 6-month sensor wear duration. The system transmits data to the Eversense CGM app. There, users can view, analyze and share glucose data. In addition, it alerts users to changes and trends in glucose levels as well.

The new integration allows users in all markets where Eversense is availab…

Ascensia, Senseonics partner with Nurse Practitioner Group on CGM insertion options

The Eversense E3 system. [Image from Ascensia/Senseonics]Senseonics (NYSE:SENS) and Ascensia Diabetes Care launched a collaboration with the Nurse Practitioner Group (NPG) today.

NPG offers multidisciplinary health services and medical staffing solutions. The collaboration aims to broaden access to the Eversense E3 continuous glucose monitor (CGM) system. Senseonics developed Eversense E3 and Ascensia distributes the system as the company’s partner.

The collaboration offers convenient at-home and in-office insertion options for diabetes patients. NPG recently completed the first patient insertion of the six-month Eversense E3 sensor in Florida. It plans to expand the initiative to other key markets across the U.S. in the coming months.

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

Ascensia completes Senseonics Eversense E3 European launch

The Eversense E3 system. [Image from Ascensia/Senseonics]Ascensia Diabetes Care announced that it successfully completed its initial European launch for the Senseonics (NYSE:SENS) Eversense E3.

Eversense E3 represents Senseonics’ next-generation continuous glucose monitor (CGM) system. Eversense E3 can be used for up to six months (180 days). This doubles the wear time of its previous-generation CGM.

Ascensia said in a news release that its launch extends to Germany, Switzerland, Poland, Italy, Spain, Norway, Sweden, the Netherlands, and Andorra. The company began its phased rollout for Eversense E3 in August.

The system received CE mark approval in June.

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