Dexcom to update next-gen G7 software, delaying FDA clearance, launch timelines

[Image from Dexcom]The CEO of Dexcom (Nasdaq:DXCM) said today that the company’s regulatory path for the next-generation G7 has been slightly delayed.

Speaking on the continuous glucose monitor (CGM) maker’s second-quarter earnings call, Dexcom Chair, President and CEO Kevin Sayer explained that the company has — based on feedback from the FDA — been tweaking the software of its next-generation G7, “slightly delaying” the expected timelines for FDA 510(k) clearance and the subsequent U.S. launch.

“We expect FDA clearance and a limited launch later this year and a large commercial launch in the U.S. in the first quarter of 2023,” Sayer said.

He added that, with preliminary discussions with payors progressing well, the company is set for a “big launch early next year.”

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Dexcom to update next-gen G7 software, delaying FDA clearance, launch timelines

[Image from Dexcom]The CEO of Dexcom (Nasdaq:DXCM) said today that the company’s regulatory path for the next-generation G7 has been slightly delayed.

Speaking on the continuous glucose monitor (CGM) maker’s second-quarter earnings call, Dexcom Chair, President and CEO Kevin Sayer explained that the company has — based on feedback from the FDA — been tweaking the software of its next-generation G7, “slightly delaying” the expected timelines for FDA 510(k) clearance and the subsequent U.S. launch.

“We expect FDA clearance and a limited launch later this year and a large commercial launch in the U.S. in the first quarter of 2023,” Sayer said.

He added that, with preliminary discussions with payors progressing well, the company is set for a “big launch early next year.”

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

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Dexcom stock dips on missed Q2 projections with broader G7 launch ‘in coming weeks’

Dexcom (Nasdaq:DXCM) shares took a hit after hours today on second-quarter results that came up shy of the consensus forecast.

Shares of DXCM were down 7.2% at $80.69 after the market closed. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up 2.4%.

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

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Dexcom stock dips on missed Q2 projections with broader G7 launch ‘in coming weeks’

Dexcom (Nasdaq:DXCM) shares took a hit after hours today on second-quarter results that came up shy of the consensus forecast.

Shares of DXCM were down 7.2% at $80.69 after the market closed. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up 2.4%.

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

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6 drug delivery innovations you need to know

From wearable insulin delivery devices to drug-eluting implants and everything in between, drug delivery innovation never stops.

Vaccines, life-saving therapeutics, vision-correcting drugs and more are being developed and marketed for delivery with all kinds of technologies.

More than a year ago, we compiled a list of eight drug delivery innovations you need to know. With some updates on some of those technologies, plus introductions to others, here are some more impressive developments you should keep an eye on:

1. Needle-free delivery

Vaccines have become a major talking point over the past couple of years amid the COVID-19 pandemic and a number of companies are working on ways to deliver them, as well as other forms of medication, through different avenues.

A major speed bump in vaccine hesitancy can be fear of needles, so the introduction of needle-free drug delivery could make big waves in the space.

Two companies pushing forward with …

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iRhythm brings another Dexcom veteran into its C-suite

iRhythm’s next CCO Chad Patterson [Image from Patterson’s LinkedIn page]iRhythm Technologies (Nasdaq:IRTC) announced today that it appointed Chad Patterson as its next chief commercial officer.

Patterson will join the wearable electrocardiogram monitors developer’s executive leadership team and, as CCO, he will oversee the company’s commercial strategy, operations and execution.

He most recently served as chief marketing officer at Dexcom. He will make the move from the continuous glucose monitor developer to iRhythm just as president and CEO Quentin Blackford did in September of 2021.

“As iRhythm expands within its core U.S. markets, into additional international geographies, and into adjacent markets, we are excited to welcome Chad to our executive team,” Blackford said in a news release. “Chad joins us at the perfect time to leverage his experience in driving significant growth in global markets as we look to execute a…

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iRhythm brings another Dexcom veteran into its C-suite

iRhythm’s next CCO Chad Patterson [Image from Patterson’s LinkedIn page]iRhythm Technologies (Nasdaq:IRTC) announced today that it appointed Chad Patterson as its next chief commercial officer.

Patterson will join the wearable electrocardiogram monitors developer’s executive leadership team and, as CCO, he will oversee the company’s commercial strategy, operations and execution.

He most recently served as chief marketing officer at Dexcom. He will make the move from the continuous glucose monitor developer to iRhythm just as president and CEO Quentin Blackford did in September of 2021.

“As iRhythm expands within its core U.S. markets, into additional international geographies, and into adjacent markets, we are excited to welcome Chad to our executive team,” Blackford said in a news release. “Chad joins us at the perfect time to leverage his experience in driving significant growth in global markets as we look to execute a…

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Zillion partners with Dexcom on CGM integration

Zillion announced today that it partnered with Dexcom (Nasdaq:DXCM) to integrate its CGM technology with Zillion’s digital health platform.

Needham, Massachusetts-based Zillion will connect Dexcom’s continuous glucose monitoring (CGM) platform with its digital health offering for the RestoreHealth program, enhancing RestoreHealth for employer and health system patients.

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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.

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