Insulet acquires insulin pump patents from Bigfoot Biomedical for $25M

Insulet (Nasdaq:PODD) announced today that it acquired assets related to Bigfoot Biomedical’s pump-based automated insulin delivery technologies.

Acton, Massachusetts-based Insulet paid $25 million to acquire the AID assets. These include certain Bigfoot patents related to pumps that may be used for AID therapy. Insulet already develops its own AID technology with its Omnipod platform.

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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 …

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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 …

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The biggest medtech stock gainers, losers in 2022

(From Ishant Mishra on Unsplash) In another roller coaster year for medtech, these are the companies that saw their stock rise and fall the most drastically.

The MassDevice MedTech 100 Index, which includes stocks of the world’s largest medical device companies, reflects the performance of many in the medtech space.

In a tough year for a lot of businesses, the Index wasn’t immune to struggles. Overall, it dropped 27.3% from this time last year. That compares to a 19.7% drop for the S&P 500 and an 8.9% dip for the Dow Jones Industrial Average.

Some businesses, though, powered through the supply chain- and inflation-related woes to see their stock rise from this time last year. Others weren’t so lucky. Here are some of the biggest gainers and losers — selected from the MedTech 100 Index — of 2022.

Biggest gainers BD — $245.27 to $254.97 — Up 4% 

While BD (NYSE:BDX) didn’t have the most significant growth, its stock remains in a …

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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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Insulet COO announces intent to retire

Charles Alpuche. [Image from Insulet’s website]Insulet (Nasdaq:PODD) issued an SEC filing confirming that Charles Alpuche, executive vice president and chief operating officer, intends to retire.

Alpuche informed the company of his decision to retire on Dec. 13. His retirement takes effect on Dec. 31, 2022.

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FDA says Insulet Omnipod Dash batteries recall is Class I

The smartphone-like Personal Diabetes Manager [PDM] is supposed to enable an Omnipod Dash user to conveniently and discreetly communicate with their Podd. [Image courtesy of Insulet]The FDA has posted a notice that an Insulet recall related to Omnipod Dash batteries is Class I, its most serious level.

Insulet recently issued a voluntary global safety notice to warn about battery problems. The Omnipod Dash is Insulet’s previous-generation insulin pump. The company since launched its FDA-cleared and CE-marked Omnipod 5 next-generation automated insulin delivery system.

The Omnipod Dash includes a Personal Diabetes Manager (PDM) — a locked-down Android mobile device with features similar to a smartphone that controls the Pod delivering insulin. The FDA says Insulet has received Insulet 455 complaints involving these battery issues, including three fires. There have been no reports of injuries or deaths.

Reported problems include battery swelling, fluid leakage…

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Insulet issues device correction on Omnipod 5 controller due to charging issue

Insulet’s Omnipod 5 with the Dexcom G6 CGM. [Image from Insulet]Insulet (Nasdaq:PODD) announced a medical device correction for its Omnipod 5 automated insulin delivery system.

Acton, Massachusetts-based Insulet’s correction relates to an issue with the Omnipod 5 controller’s charging port and cable. The correction does not impact the Omnipod 5 pod, the previous-generation Omnipod Dash and Omnipod, or compatible Android smartphone devices with the Omnipod 5 app installed.

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Insulet stock rises on Street-beating Q3, raised sales guidance

Insulet (Nasdaq:PODD) shares ticked up after hours today on third-quarter results that came in ahead of the consensus forecast.

Shares of PODD rose 8.1% at $276 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day down 3.8%.

The Acton, Massachusetts-based company posted a $5.2 million loss for the quarter. That equals 8¢ per share on sales of $340.8 million for the three months ended Sept. 30, 2022.

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Insulet warns of battery issues with some Omnipod Dash PDM devices

The smartphone-like Personal Diabetes Manager [PDM] is supposed to enable an Omnipod Dash user to conveniently and discreetly communicate with their Podd. [Image courtesy of Insulet]Insulet (Nasdaq:PODD) recently issued a voluntary global safety notice to warn of battery problems with its Omnipod Dash system.

The Omnipod Dash is Insulet’s previous-generation insulin pump. The company since launched its FDA-cleared and CE-marked Omnipod 5 next-generation automated insulin delivery system. Insulet’s notice went out to current and past users of the Omnipod Dash insulin management system.

According to the notice in Europe on Nov. 2 and a news release posted on Nov. 4, the warning relates to the Omnipod Dash Personal Diabetes Manager (PDM) and its battery. Insulet said there have been 50 complaints — but no reports of serious injury or death — related to the Omnipod Dash PDM battery issues. The notice does not apply to the Omnipod Dash pods or the Omnipod i…

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Here’s what diabetes tech companies are doing for National Diabetes Awareness Month

As we enter November, we enter National Diabetes Awareness Month. A number of diabetes technology developers plan to mark that in a special way.

Dexcom (Nasdaq:DXCM), Insulet (Nasdaq:PODD) and Embecta (Nasdaq:EMBC) all announced their plans to celebrate.

Last year, a handful of companies marked the month — which includes World Diabetes Day (Nov. 14) — in a series of ways. Here’s how they’re doing it this year.

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

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Insulet wins CE Mark for Omnipod 5 for children 2 and up

Insulet’s Omnipod 5 with the Dexcom G6 CGM. [Image from Insulet]Insulet (Nasdaq:PODD) announced today that it received CE mark approval in Europe for its Omnipod 5 automated insulin delivery system.

Insulet can now market Omnipod 5 in Europe for individuals 2 years and older with type 1 diabetes. Acton, Massachusetts–based Insulet said it represents the first CE-marked tubeless hybrid closed loop system

The latest-generation Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals 6 years of age and older. Last month, the FDA cleared Omnipod 5 for individuals aged 2 and older.

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