These diabetes devices are set to launch in 2024

The Stelo glucose monitor. [Image courtesy of Dexcom]The diabetes space continues to innovate and it doesn’t look like that’s stopping any time soon, with 2024 set to be another banner year.

At the end of 2023, we compiled a list of the 10 biggest diabetes technology stories of the year. Some of those stories didn’t end in 2023, though, as a few major product launches loom on the horizon.

New CGMs, insulin pumps and combinations of the two will all be coming to the market over the next several months. Here are some of the most highly-anticipated product launches set to take place in the diabetes space in 2024 — plus some of the tech that’s already launched:

Diabetes launches on the horizon Medtronic’s new pump-sensor combo

In January, Medtronic won CE mark for its MiniMed 780G automated insulin delivery system with the Simplera Sync sensor.

The MiniMed 780G with the Simplera Sync CGM and accompanying devices. [Image courtes…
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Embecta beats The Street in Q1, raises guidance as insulin pump development moves along

Embecta (Nasdaq:EMBC) shares took a hit this morning despite Street-beating first-quarter results and increased 2024 guidance.

Shares of EMBC fell 7.8% at $16.37 apiece as the market opened today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — opened today relatively even.

The Parsippany, New Jersey-based BD Diabetes spinoff posted profits of $20.1 million in the quarter. That equals 35¢ per share on sales of $277.3 million for the three months ended Dec. 31, 2023. Embecta recorded a 42.9% bottom-line slide on sales growth of 0.6%.

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

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Embecta submits insulin patch pump for FDA clearance

Embecta (Nasdaq:EMBC) announced today that it submitted a 510(k) premarket filing to the FDA for its proprietary insulin patch pump.

The Parsippany, New Jersey-based BD Diabetes spinoff developed a proprietary, disposable pump for people with type 2 diabetes. The company provided analysts with some details on the makeup of the open-loop system earlier this year. It also has a closed-loop version under development to follow. That version features an embedded algorithm that requires Embecta to run a clinical study.

Embecta describes the pump as convenient and discreet, featuring a 300-unit insulin reservoir. Embecta designed it to lighten the burden of managing diabetes while improving user outcomes. Colleen Riley, the company’s CTO, said the pump design is informed by “the unique needs” of people with type 2 diabetes and their healthcare providers.

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Embecta CEO sees GLP-1 opportunities as company progresses on insulin patch pump

Embecta CEO Dev Kurdikar

Embecta (NYSE: EMBC) + CEO Dev Kurdikar says the company set out for its second full year since spinning off from BD with three clear goals.

The company wanted to keep the core business strong, continue progressing on the separation and standing on its own and, finally, continue investing in growth — namely on its insulin patch pump development program.

Embecta’s core business continued to grow, completed a number of crucial projects related to the separation and continued the development of the patch pump with new partnerships and more.

“For now I’ll say I’m very pleased with our progress,” Kurdikar told Drug Delivery Business News. “We’ve continued exactly on the path that we laid out more than two years ago, now. We saw substantive progress in 2023. For 2024, it’s the same priorities, but we’re looking forward to getting closure on…

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FDA warning doesn’t affect Embecta syringes, company says

The U-500 insulin delivery syringe. The FDA’s warning does not affect syringes like this one made by Embecta. [Image from Embecta/BD]Embecta (Nasdaq:EMBC) says an FDA safety communication regarding certain plastic syringes has no impact on its own products.

The FDA yesterday warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality issues associated with several Chinese syringe manufacturers.

Embecta, the BD diabetes business spinoff, manufactures syringe devices for the delivery of insulin. However, the manufacturing for these devices only takes place in the U.S.

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Embecta increases 2023 guidance, reports closed-loop insulin delivery tech progress

Embecta (Nasdaq:EMBC) shares rose this morning as it increased its full-year guidance and shared an update on its automated insulin delivery technology.

The company also reported third-quarter results that came in ahead of the consensus forecast.

Shares of EMBC ticked up 3.1% at $22.27 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — remained unchanged.

Since its spinoff from BD last year, Embecta says it continues to make progress on the development of a closed-loop insulin delivery system for type 2 diabetes. The system utilizes its proprietary patch pump system, which holds FDA breakthrough device designation.

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

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Embecta stock rises on Q2 results, reports progress on automated insulin delivery tech

Embecta (Nasdaq:EMBC) shares ticked up today on second-quarter results that topped the consensus forecast, leading to a guidance increase.

Shares of EMBC grew 2.1% to $29.52 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 0.1%.

The Parsippany, New Jersey-based diabetes technology company posted profits of $14 million. That amounts to per share on sales of $277.1 million for the three months ended March 31, 2023.

Embecta, which spun off from BD last year, recorded a bottom-line slide of 82.4% on sales growth of 0.9%.

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

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Analysts receive update on Embecta insulin patch pump progress

BTIG analysts Marie Thibault and Sam Eiber met with Embecta (Nasdaq:EMBC) executives last week and received an update on the company’s current position.

Thibault and Eiber met with Embecta CFO Jake Elguicze and Head of Investor Relations Pravesh Khandelwal.

Among a series of updates, the BTIG report said Embecta expects a “transitional period” in the next 12-18 months. That includes standing up its own business units and exiting remaining transition service agreements (TSAs), plus investing in growth opportunities.

The report also updated on the BD diabetes spinoff’s insulin patch pump development and other potential business opportunities. Thibault and Eiber maintained a “Neutral” rating on Embecta stock.

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

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Embecta stock soars on Street-beating Q4, raised 2023 guidance

Embecta (Nasdaq:EMBC) shares received a boost today on fourth-quarter results that came in well ahead of the consensus forecast.

Shares of EMBC ticked up 7.9% at $30.67 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 11.3%.

Wall Street’s positive reaction to the results is likely attributable to Embecta’s sizeable guidance increase for 2023.

The company now projects adjusted EPS to range between $2.20 and $2.35. That marks a significant rise from previous expectations for between $1.75 and $2. Embecta also upped its revenue guidance, now projecting between $1.084 billion and $1.107 billion. Its previous range fell between $1.05 billion and $1.073 billion.

The company now projects adjusted EPS to range between $2.20 and $2.35. That marks a significant rise from previous expectations of between $1.75 and $2. Embecta also upped i…

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How Embecta started strong and what’s ahead for the BD diabetes spinoff

Embecta CEO Dev Kurdikar Ten months after spinning off from BD, Embecta CEO Dev Kurdikar lays out what the future holds for the diabetes technology company.

When Embecta became a standalone company in April 2022, CFO Jake Elguicze said he felt it was “uniquely positioned.”

As a pure-play diabetes technology developer, its beginning phase hardly mirrors a normal startup. The former diabetes arm of BD brought with it nearly a century of experience in the space.

Elguicze said Embecta had scale at about $1.2 billion in annual revenue. It also kicked off with a strong geographic reach and no ties to any one product.

Still, CEO Devdatt “Dev” Kurdikar last week told Drug Delivery Business News that the past 10 months still involved a lot of work around the spinoff. But, the future looks bright for Embecta, he says.

“We’ve taken a business that was part of a much larger business for close to 100 years,” Kurdikar explained. “Now, we’re doing the work of se…

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Embecta opens new global headquarters in New Jersey

Embecta (Nasdaq:EMBC) announced today that it held a grand opening ceremony at its new global headquarters in New Jersey.

The BD Diabetes business spinoff opened its new headquarters at 300 Kimball Drive, Suite 300, in Parsippany, New Jersey. The site houses members of the Embecta leadership team, global support functions and North American commercial organization.

Embecta has approximately 2,000 employees globally.

“With a number of our employees currently making their homes in New Jersey, the ability to tap into one of the nation’s most significant concentrations of highly-educated, experienced medical technology talent, and easy access to international airports and interstate highways, we see Parsippany as the ideal location to establish our worldwide headquarters,” said Devdatt (Dev) Kurdikar, president and CEO, Embecta.

“We are a new company, but our roots in New Jersey go back nearly 100 years when, as part of BD, we developed the first dedi…

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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…

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