May 2024 edition: Intuitive’s DV5, pediatric device design and diabetes tech



 

The Intuitive da Vinci 5’s top design changes: ‘This is groundbreaking for robotic surgery’ Small patients, big design challenges: Pediatric device experts guide engineers on solutions The biggest diabetes tech news out of ATTD 2024 5 things that will shape surgical robotics over the next decade All eyes on Intuitive’s da Vinci 5

It’s hard to think of a product update with higher stakes for a device developer — and the medtech industry — than Intuitive Surgical’s da Vinci 5 robotic-assisted surgery system.

All eyes are on the world’s leading surgical robotics developer as it rolls out the next generation of its flagship system after winning FDA clearance. Will the new features and long list of design changes put even more distance between surgical robotics and conventional laparoscopy? Is Intuitive advancing its technology rapidly enough to maintain or expand its lead ahead of larger device manufacturers, maturing surgical robotics developers and fas…

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Insulet picks new CFO following McMillan’s move to 3M spinoff

Ana Maria Chadwick [Image courtesy of Insulet]Insulet (Nasdaq: PODD) + announced today that it appointed Ana Maria Chadwick as its new EVP, CFO and treasurer.

Chadwick’s appointment — which goes into effect on April 22, 2024 — follows an extensive search process conducted by Insulet. That search spanned nearly six months after former CFO Wayde McMillan left for 3M’s Solventum healthcare spinoff in October.

Lauren Budden served as interim CFO and treasurer following McMillan’s departure. Insulet plans for her to continue in her role as group VP, chief accounting officer and controller.

Chadwick now joins Acton, Massachusetts-based Insulet, a developer of automated insulin delivery technology, with more than 30 years of experience in propelling growth within organizations.

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

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The biggest diabetes tech news out of ATTD 2024

This is a screenshot from a video demonstrating the features of the new Roche Accu-Chek SmartGuide CGM at ATTD 2024.

Every year, the diabetes community comes together for the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD).

In the 17th installment at the start of this month, some of the biggest names shared new studies and technologies set to advance the diabetes space. Dexcom, Abbott, Medtronic and more contributed on their end, while some new technologies are coming to the fore as well.

Here are the biggest stories from this year’s ATTD conference in Florence, Italy. (You can also check out the biggest news out of ATTD in 2023 and 2022.)

Dexcom’s direct-to-watch feature

Dexcom announced at ATTD that it introduced a direct-to-Apple-Watch feature for its G7 continuous glucose monitor (CGM) users.

The company plans a phased launch for all G7 iOS users everywhere by the end of the second quarter of …

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Insulet shares data demonstrating Omnipod 5’s superiority to pump therapy

The Omnipod 5 with the Abbott FreeStyle Libre 2 Plus. [Image courtesy of Insulet]Insulet (Nasdaq: PODD) + today announced positive results from a clinical trial pitting its Omnipod 5 against non-automated insulin therapy.

Acton, Massachusetts-based Insulet conducted its first randomized controlled trial showing improved glycemic and patient-reported outcomes in type 1 diabetes with the Omnipod 5 automated insulin delivery (AID) system. The company presented results at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Florence, Italy.

Dr. Eric Renard of Montpellier University Hospital presented the data. It highlighted Omnipod 5’s efficacy and safety compared to insulin pump therapy with CGM in adults with type 1 diabetes in the U.S. and France. The study marked the first Omnipod 5 randomized controlled trial to date. It’s also the first time the system has been evaluated by internati…

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Report: Insulet trumps Medtrum again in French patent spat

Left: a diagram of the Insulet insulin pump patent in question. Top right: The Insulet Omnipod 5. Bottom right: The Medtrum TouchCare Nano.

JUVE-Patent reports that the Judicial Court of Paris again ruled in favor of Insulet (Nasdaq: PODD) + in its patent battle with Medtrum.

According to the report, the court sided with Insulet in a case regarding the company’s patent (EP 1 874 390). The ruling finds that Medtrum’s A6 and A7+ TouchCare insulin pump devices infringe the valid Insulet patent.

However, JUVE-Patent says the judges found that Medtrum’s clinical trials for the A7+ device was responsible for the infringement. The outlet says this is a move “not before seen in French courts.” So, in this instance, Insulet won the patent spat before the infringing devices went commercial. The report says courts usually deliver these types of rulings once products hit the market.

This ruling…

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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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Insulet begins limited rollout of Omnipod 5 with Dexcom G7, grows sales by 38% in Q4

The Insulet Omnipod 5 [Photo courtesy of Insulet]Insulet (Nasdaq: PODD) + announced today that it began a limited market release of the Omnipod 5 with the Dexcom G7.

This marks the latest integration of Dexcom’s next-generation CGM into automated insulin delivery technology. Omnipod 5, Insulet’s newest patch pump offering, previously worked with the G6 in the U.S. It also recently integrated the system with Abbott’s FreeStyle Libre 2 Plus in Europe.

Insulet previously suggested that G7 integration would come early in 2024. In the company’s fourth-quarter earnings report — which included Street-beating results — the company confirmed the initial limited rollout began recently.

Shares of PODD fell nearly 7% at $183.50 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 up 0.6%.…

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Insulet integrates Abbott FreeStyle Libre 2 Plus, Omnipod 5 in Europe

The Omnipod 5 with the Abbott FreeStyle Libre 2 Plus. [Image courtesy of Insulet]Insulet (Nasdaq: PODD) + announced today that it received CE mark approval for the integration of the Abbott (NYSE: ABT) + FreeStyle Libre 2 Plus with Omnipod 5.

European approval covers the compatibility of Abbott’s glucose sensor with the Insulet automated insulin delivery system for individuals aged two years and older with type 1 diabetes.

Currently, Omnipod 5 works with Dexcom CGM. Right now, it has compatibility with the previous-generation G6 as the companies work on integrating the G7. However, Insulet hinted at the future integration with Abbott’s popular FreeStyle Libre system midway through last year.

This also marks the second major insulin pump integration for Abbott in 2024. Last month, the company announced FreeStyle Libre 2 Plus compatibility with the Tandem Diabete…

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The top IVD and diabetes tech stories of 2023

The G7 CGM helps users manage their diabetes. [Image courtesy of Dexcom]Over the course of 2023, the medtech industry produced another impressive year of innovation, with news coming from a variety of spaces.

Chiefly among those were diabetes technologies and in vitro diagnostics (IVDs). We saw regulatory nods, product launches, funds raised and mergers fall apart.

Looking at those two spaces in particular, here are five diabetes and IVD stories that caught our attention in 2023:

5. Cytovale raises $84M Series C for sepsis diagnostic

In November, Cytovale announced that it raised $84 million in a Series C funding round to support its rapid sepsis diagnosis test. Cytovale earmarked funds to support the wider expansion of this testing technology.

The FDA cleared the IntelliSep test, which aids hospital emergency departments and health systems, in January. IntelliSep provides test results in under 10 minutes, offering actionable answers using standard b…

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Insulet enters into new credit agreement worth $487.5M in term loans

Insulet (Nasdaq: PODD) + announced that it entered into an amended credit agreement to replace existing term loans.

The automated insulin delivery technology developer entered into the agreement with Morgan Stanley Senior Funding. This agreement amended a credit agreement dated May 4, 2021. Pursuant to the agreement, the $487.5 million in term loans outstanding under the existing agreement was replaced with an equal amount of new term loans.

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

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Insulet has new directors as former CEO is set to retire from board

Shacey Petrovic

Insulet (Nasdaq: PODD) + announced today that it named a duo of new board directors with high-profile figures set to retire.

Acton, Massachusetts-based Insulet appointed Flavia Pease and Timothy Stonesifer to its board. Former CEO Shacey Petrovic, along with Corinne Nevinny, intend to retire from the board in May.

Petrovic spent more than seven years as CEO at the automated insulin delivery technology developer. She stepped down from the corner office in May 2022 and remained on the board as Jim Hollingshead took over as CEO. Petrovic spent nearly six years on the board at Insulet, while Nevinny offered five years of service to the board.

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

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Insulet has a Class I recall for the Omnipod 5 Android App

Insulet’s Omnipod 5 with the Dexcom G6 CGM. [Image from Insulet]The FDA labeled a recall of the Insulet (NYSE: PODD) + Omnipod 5 App for Android smartphones as Class I, the most serious kind.

Insulet’s recall — a correction, not a product removal — affects software versions 1.1-1.2.3 for the Omnipod 5 automated insulin delivery system. It distributed the software between April 20, 2023, and Dec. 20, 2023. The company initiated the recall, which affects 28,919 devices in the U.S., on Nov. 7, 2023.

The Omnipod 5 App uses SmartAdjust technology to help adjust insulin delivery based on real-time and future blood sugar levels. Its SmartBolus Calculator computes recommended bolus doses, while the app considers user-inputted carbohydrates and other sensor data. The recalled app is an Android-based software provided on either a locked-down controller or downloaded on a smartphone. Its uses include activating/deactivat…

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