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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Medtech sales reach a record high as R&D spend and employee counts climb

The Medtech Big 100: The world’s largest medical device companies

The medtech industry is bouncing back from the economic fallout caused by the COVID-19 pandemic, according to an analysis of our Medtech Big 100 data.

The medical device industry has seemingly recovered from the economic headwinds caused by the COVID-19 pandemic, according to a Medical Design & Outsourcing analysis of financial data from the Medtech Big 100, 100 of the largest medical device companies’ most recent annual results.

More than half of the companies listed in this year’s Big 100 ranking reported positive growth over their prior-year sales. Total revenue, research spending and employment figures were up significantly as the industry adjusts to a world with COVID-19 challenges.

For this analysis, we compared the performance of the Medtech Big 100 companies in 2021 and early 2022 with their results in 2020. Due to t…

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Dexcom names Jake Leach chief operating officer

Dexcom COO Jake Leach

Dexcom (Nasdaq:DXCM) announced that it promoted chief technology officer Jake Leach to the chief operating officer (COO) role.

Leach served as CTO since 2018, leading the company’s research, product development, product management and engineering departments. He joined the company in 2004 to lead the development of sensor electronics for its first commercial continuous glucose monitor (CGM) system.

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10 big earnings stories from the last quarter: How are medtech stocks doing now?

(From Ishant Mishra on Unsplash)

Economic uncertainty appears to have produced a wide variety of medtech earnings stories during the most recent round of quarterly results.

Some medical device companies received massive boosts from their quarterly performance, while others saw their stocks sink amid missed projections and other various issues. The phrase “macroeconomic headwinds” was a common phrase. Medtech faces a strong U.S. dollar (a hurdle for American companies selling overseas), supply chain disruption and inflation.

For all of MassDevice’s medtech earnings stories, click HERE

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has mostly been on the rise over this period, getting as high as $90.10 per share (a 6.5% increase from the price of $84.60 at the start of the period). It is now at $85.27 for the last month, representing a 0.7% r…

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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.”

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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%.

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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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