July 2022 Issue: Pulsed-field ablation, DeviceTalks Boston and the Pharma 50

 

What is pulsed-field ablation? Here’s what you need to know

Dexcom CEO expects ‘science boom’ with CGM, automated insulin delivery

Tips for vetting contract manufacturers

They said it at DeviceTalks Boston

FDA can’t explain drop in device recalls, but experts point to COVID disruption

2022 Pharma 50: The 50 largest pharmaceutical companies

Innovators shake up the Pharma 50

As a father raising a toddler and an infant, I was relieved by the latest milestone in the COVID-19 pandemic: the authorization of vaccines for children between 6 months and 5 years.

The good news came as Pharma Editor Brian Buntz and the rest of our team were putting the final touches on this edition’s Pharma 50 project. It’s our annual ranking of the biggest pharmaceutical companies by global revenue, featured on our affiliated Drug Discovery & Development site. (Our Big 100 report on largest medic…

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Dexcom focuses on early diabetes diagnosis as COVID links emerge

Dexcom VP of Global Clinical Initiatives Tomas Walker [Photo courtesy of Dexcom]New evidence is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure.

In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said.

Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s proactive approach to chronic COVID-19 conditions, technology that can help diagnose new cases, and the likelihood that particular devices and components will be in greater demand in the years ahead.

Get the full story at our sister site, Medical Design & Outsourcing.

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Dexcom focuses on early diabetes diagnosis as COVID links emerge

Dexcom VP of Global Clinical Initiatives Tomas Walker [Photo courtesy of Dexcom]

New data is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure.

In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said.

Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s proactive approach to chronic COVID-19 conditions, technology that can help diagnose new cases, and the likelihood that particular devices and components will be in greater demand in the years ahead.

The following has been lightly edited for space and clarity.

MDO: How does the SARS-CoV-2 virus and its COVID-19 disease affect the pancreas?

Walker: In February, March of 2020, there were a couple of papers published out of China very early in the expe…

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Dexcom quadruples number of shares

Dexcom (Nasdaq:DXCM) recently filed a restated certificate of incorporation to effect a four-for-one forward stock split.

Shares of DXCM were down 0.9% at $293.85 per share at market close on Friday, June 10. Following the stock split, shares moved down 75.33% to $72.50 before the market opened this morning.

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

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The biggest stories from the American Diabetes Association (ADA) 2022 Scientific Sessions

For the 82nd time, the American Diabetes Association (ADA) Scientific Sessions convened to highlight all the innovations within the diabetes technology space.

Major players like Dexcom, Medtronic, Abbott and more continue to plug along, while companies like Bigfoot Biomedical, One Drop and others shared data backing the technology that they bring to the table.

The data showcased at ADA supported the usual continuous glucose monitoring (CGM) and automated insulin delivery (AID) technology, plus different digital health platforms and diabetes reversal procedures.

BTIG analyst Marie Thibault wrote in a report that there was plenty of buzz on the ground at the event, particularly around Insulet’s Omnipod 5 AID system, Abbott’s recently FDA-cleared FreeStyle Libre 3 CGM and Bigfoot Biomedical’s Bigfoot Unity platform.

“In general, we believe that accuracy and clinical benefit is proven for all commercial CGM and AID offerings an…

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Dexcom CEO expects ‘science boom’ with CGM, automated insulin delivery

[Image from Dexcom] With the G7 nearing FDA clearance, Dexcom leadership foresees major innovations for integrated automated insulin delivery down the line.

Kevin Sayer began thinking about automated insulin delivery all the way back in 1994 when he was working at MiniMed. Nearly 30 years later, as CEO of Dexcom (Nasdaq:DXCM), that space continues to pique his interest.

In the 90s, MiniMed ran trials with a fully implantable system before Medtronic bought the company. Sayer admits the system with an implantable pump and sensor wasn’t particularly practical, but it planted the seeds for what could grow.

Now with Dexcom, the maker of the leading G6 continuous glucose monitoring (CGM) system — and the next-generation G7, which is expected to receive FDA clearance soon — Sayer has seen the integration of CGM with automated insulin delivery through partnerships with Insulet and Tandem Diabetes Care and he believes that, with pump penetration not yet passing 50% of i…

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Dexcom quashes talk of Insulet merger, says discussions are not ongoing

Dexcom (Nasdaq:DXCM) has today issued a statement denying recent rumors of a potential merger with Insulet (Nasdaq:PODD).

Last week, reports circulated saying talks over a potential acquisition were ongoing with an agreement between the two diabetes technology developers on the horizon in the coming weeks.

On the back of the Dexcom statement, DXCM shares were up 7% at $308.87 per share as the market opened today. Conversely, PODD shares sank 11% to $209.65.

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

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Report: Dexcom in talks to acquire Insulet

Major players in the diabetes space could join forces as Dexcom (Nasdaq:DXCM) is reportedly in discussions to acquire Insulet (Nasdaq:PODD).

Bloomberg reported today that people “with knowledge of the matter” have said talks are ongoing over a potential acquisition and even said an agreement could be reached “in the coming weeks.” Bloomberg’s sources preferred to remain anonymous because the information is private and both companies declined to offer comment, the news outlet said.

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

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How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7

The Dexcom One platform. [Image from Dexcom]

A lot of talk around Dexcom (Nasdaq:DXCM) in the last couple of years has centered around its next-generation G7 continuous glucose monitor.

The latest iteration of the company’s CGM platform has already garnered CE mark this year and awaits FDA approval, with some expectations for that to come after the American Diabetes Association’s Scientific Sessions next month. The company also presented new data highlighting the accuracy the G7 in children at last month’s Advanced Technologies & Treatments for Diabetes (ATTD) conference.

Dexcom Chief Technology Officer Jake Leach recently told Drug Delivery Business News that, while the excitement around G7 remains, that’s far from the only thing the San Diego-based company has to offer.

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

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How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7

The Dexcom One platform. [Image from Dexcom]A lot of talk around Dexcom (Nasdaq:DXCM) in the last couple of years has centered around its next-generation G7 continuous glucose monitor.

The latest iteration of the company’s CGM platform has already garnered CE mark this year and awaits FDA approval, with some expectations for that to come after the American Diabetes Association’s Scientific Sessions next month. The company also presented new data highlighting the accuracy the G7 in children at last month’s Advanced Technologies & Treatments for Diabetes (ATTD) conference.

Dexcom Chief Technology Officer Jake Leach recently told Drug Delivery Business News that, while the excitement around G7 remains, that’s far from the only thing the San Diego-based company has to offer.

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

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CGMs, insulin pumps and more: the biggest diabetes news to come out of ATTD 2022

All kinds of technologies were on display at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Barcelona last week.

From continuous glucose monitoring (CGM) to automated insulin delivery, with plenty in between, a number of companies shared positive data for their diabetes offerings.

Here are five of the biggest stories to come out of ATTD 2022:

 

Dexcom’s G7 is accurate in pediatric T1D patients

Dexcom (Nasdaq:DXCM) published new data highlighting the accuracy of the next-generation G7 continuous glucose monitor in children.

The study, published in the Journal of Diabetes and Scientific Technology, evaluated the G7 CGM in children and adolescents with type 1 diabetes. G7, which last month won CE mark approval, remains under FDA 510(k) review.

 

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

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Dexcom study shows strong accuracy for next-gen G7 CGM in pediatric T1D patients

[Image from Dexcom]Dexcom (Nasdaq:DXCM) published new data highlighting the accuracy of the next-generation G7 continuous glucose monitor in children.

San Diego-based Dexcom’s study, published in the Journal of Diabetes and Scientific Technology, evaluated the G7 CGM in children and adolescents with type 1 diabetes. G7, which last month won CE mark approval, remains under FDA 510(k) review.

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

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