Dexcom submits new glucose sensor to FDA, expects launch this summer

The Stelo glucose monitor. [Image courtesy of Dexcom]Dexcom (Nasdaq: DXCM) + announced that it submitted its new Stelo glucose sensor to the FDA for review at the end of last year.

The continuous glucose monitor (CGM) maker designed Stelo specifically for people with type 2 diabetes who do not use insulin. San Diego-based Dexcom designed Stelo for a 15-day wear with a cash-pay option. It features a software experience tailored specifically for non-insulin users.

In early 2023, Dexcom Chair, President and CEO, Kevin Sayer hinted at potential new avenues when speaking to Drug Delivery Business News. He explained that the company wanted to broaden its focus, even revising its mission statement.

At the company’s June Investor Day event, it revealed its plans to bring the new product to market in the U.S. in 2024. According to Dexcom, the target population includes approximately 70% of Americans with diabetes.

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These 10 medtech companies care a lot about R&D

Of the 100 largest medical device companies, these 10 firms have spent the largest portion of their revenues on research and development.

Each year, Medical Design & Outsourcing compiles a list of the 100 largest medtech companies around the world and ranks them based on annual revenue for the most recently reported fiscal year. We also consider research and development spending because it can indicate where innovation occurs in the industry.

According to this year’s Big 100 analysis, the ranking of the companies that spent the biggest percentage of their revenue on R&D was mixed. While companies with the highest sales spent the most on R&D in previous years, that was not the case this year. Companies that are in the bottom 50 of our Big 100 list dedicated a greater portion of revenue to research.

Only one company on the R&D spenders list was ranked among the top 25 on the Big 100 – Edwards Lifesciences.

Read on to discover t…

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The 10 biggest diabetes tech stories from 2023

Medtronic, EOFlow, Dexcom, Beta Bionics and Tandem Diabetes Care all contributed some of the biggest diabetes technology stories of 2023.

It was another banner year for diabetes technology, with regulatory approvals, product launches and M&A all playing their part.

Diabetes technology’s impressive 12 months marked a major trend across medtech as a whole, too.

In 2022, the diabetes space saw plenty of progress from some of its biggest names and this past year proved no different. Big hitters like Dexcom, Abbott, Medtronic, Insulet and more all contributed to some of the biggest stories in 2023. External factors — like popular GLP-1 drugs and big tech names looking to enter the space — also made the cut.

Here are 10 of the most intriguing diabetes technology stories from the past 12 months.

Medtronic was set to buy EOFlow — until it wasn’t

The medtech giant made a big splash in the insulin delivery space when it announced its plan to buy South K…

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The top medtech trends of 2023

The top medtech trends of 2023 included innovations such as artificial intelligence, new GLP-1 weight loss drugs and some long-awaited medtech finally receiving regulatory nods.

With health providers facing additional challenges on top of an ever-uncertain economic environment, medtech companies also made major readjustments: layoffs, spinoffs, reorganizations and much more.

Here are the top stories that caught the attention of MassDevice readers and editors in 2023.

Top 2023 medtech trend No. 10: Questions about GLP-1 drugs

U.S. health providers wrote more than 9 million prescriptions in just three months for Wegovy, Ozempic and similar glucagon-like peptide-1 (GLP-1) weight loss drugs, according to analytics firm Trilliant Health. The popularity and initial effectiveness of the new drugs had medtech industry analysts asking a lot of questions about how the potential health benefits could reduce demand for devices. Medical device executives, however, we…

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Beta Bionics integrates iLet bionic pancreas with Dexcom G7

The iLet bionic pancreas and the Dexcom G7 CGM. [Image courtesy of Beta Bionics]Beta Bionics announced today that it began the U.S. launch of its iLet bionic pancreas with the Dexcom G7 continuous glucose monitor (CGM).

The launch marks the second G7-compatible automated insulin delivery system to hit the market in as many days. Yesterday, Tandem Diabetes Care became the first to launch an artificial pancreas using Dexcom’s next-generation CGM technology.

With a firmware update, users can update their iLet to integrate with the Dexcom G7 with no additional cost for new hardware.

To upgrade, users can download or update their iLet app on the Apple App Store or Google Play Store, available Dec. 18. Once updated, they can change the firmware on their iLet bionic pancreas and select their CGM. Other features help to streamline the setup process as well.

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

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Tandem Diabetes Care launches first automated insulin pump integrated with Dexcom G7 CGM

The t:slim X2 pump with the Dexcom G7 CGM. [Image courtesy of Tandem Diabetes Care and Dexcom]Tandem Diabetes Care (Nasdaq:TNDM) announced today that it launched its updated t:slim X2 insulin pump software with the Dexcom (Nasdaq:DXCM) +  G7.

Integration makes Tandem the first to offer automated insulin delivery with the latest-generation Dexcom continuous glucose monitor (CGM).

The FDA cleared the next-generation Dexcom G7 in December 2022. By February of this year, the company began the U.S. launch of the G7.

However, integration with automated insulin delivery partners, like Tandem, Insulet and Beta Bionics, took a little longer.

Dexcom EVP and COO Jake Leach told Drug Delivery Business News in October that the company anticipated a G7-t:slim X2 launch by the end of the calendar year.

“The Dexcom G7 and t:slim X2 insulin pump integration is the culmination of years of partnership and a shared commit…

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‘A safe pair of hands’ — Medtech’s investment in Ireland continues to grow

Killilagh, Ireland. [Image by Sean Whooley]Medtech established its presence in Ireland many years ago and still, companies continue to invest in the ever-growing country.

Boston Scientific established operations in Ireland in 1994, while Abbott has more than 70 years in the country. Medtronic, now officially headquartered in Dublin, has spent more than 40 years in Ireland and even hosted its 2023 annual meeting in the country.

Those companies, plus many more, continue to invest in Ireland, while more big names in medtech are coming to the table. Dexcom, for instance, earlier this year chose Athenry as its first European manufacturing location with a more than $325 million investment.

Speaking to MassDevice, Dexcom EVP of Global Operations, Barry Regan, explained what attracted the company to the growing medtech hub.

“One way I would describe Ireland when it comes to medtech operations and manufacturing is it’s a safe pair of hands,”…

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Here’s what diabetes tech companies are doing on World Diabetes Day

Every November, the diabetes community comes together to recognize both National Diabetes Month in the U.S. and World Diabetes Day.

World Diabetes Day falls on today, Nov. 14, to mark the birthday of Sir Frederick Banting. Banting discovered the insulin hormone along with Charles Herbert Best in 1922.

In an effort to drive awareness and understanding of the chronic condition, a number of medtech companies in the diabetes space undertake efforts each year to celebrate and draw attention to the day and month recognizing the community. We compiled lists in 2021 and 2022 to share some of the initiatives brought forward by these companies.

On World Diabetes Day in 2023, here is what medtech’s diabetes community is doing:

Abbott

Abbott (NYSE:ABT) launched its new “Countdown at a Crossroads” initiative to mark National Diabetes Awareness Month.

The initiative features an animated installation promoting diabetes awareness at the Oculus Center…

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Dexcom raises awareness on World Diabetes Day

[Image courtesy of Dexcom]Dexcom (Nasdaq:DXCM) today announced its effort to raise awareness for diabetes technology on World Diabetes Day.

The continuous glucose monitor (CGM) maker aims to highlight the need to improve access to diabetes technologies. It follows Abbott and Insulet as companies look to recognize World Diabetes Day and National Diabetes Awareness Month.

Dexcom unveiled a first-of-its-kind global portrait gallery as part of its “#SeeDiabetes” initiative. It aims to offer a look at people living with diabetes from all walks of life. Australian model and Dexcom technology user Bambi Northwood Blyth serves as creative director. Portrait photographer Fernando Sippel photographed users from around the world.

The initiative features a number of notable Dexcom users. It includes musical artist and actor Nick Jonas, Grammy-winner Patti LaBelle, actor Victor Garber and more.

Get the full story at our sis…

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NICE recommends automated insulin delivery tech rollout in UK, Medtronic, Dexcom applaud

The MiniMed 780G with the Guardian 4 sensor. [Image courtesy of Medtronic]An independent committee of the National Institute for Health and Care Excellence (NICE) voiced support for closed-loop insulin delivery.

The UK-based institute recommended offering automated insulin delivery (AID) for people whose type 1 diabetes is not controlled with their current device despite best possible management with an insulin pump or real-time or intermittently scanned continuous glucose monitoring (CGM).

Hybrid closed-loop systems utilize a CGM attached to the body that sends data to a body-worn insulin pump. They calculate the necessary insulin delivery to the body to keep blood glucose levels within a healthy range.

NICE, with NHS England, agreed to first offer hybrid closed-loop systems to certain people who already have an insulin pump. These include all children, young people, and women who are pregnant or planning a pregnancy. It comprises part of a five-year rollo…

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Dexcom stock rises after hours on raised 2023 guidance, $500M share repurchase program

Dexcom (Nasdaq:DXCM) shares got a massive boost on third-quarter results that came in well ahead of the consensus forecast.

The San Diego-based continuous glucose monitor (CGM) maker also announced a $500 million share repurchase program in conjunction with its third-quarter results. The repurchase program follows a $1 billion senior convertible note offering this year, plus a 4-for-1 reverse stock split executed last year.

Shares of DXCM skyrocketed nearly 10% at $88.80 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 nearly 2%.

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

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Dexcom launches next-gen G7 CGM in Canada

The G7 CGM. [Image courtesy of Dexcom]Dexcom (Nasdaq: DXCM) + today announced the commercial launch of its next-generation G7 continuous glucose monitor (CGM) in Canada.

The San Diego-based company expects to make its latest CGM technology available to Canadians on Oct. 10, 2023. It covers people with all types of diabetes aged two and older, including those who are pregnant, in the country.

G7 received FDA clearance in December 2022 and Dexcom launched the device in the U.S. in February of this year.

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

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