Dexcom G6 CGMs win reimbursement coverage in Japan

The G6 platform. [Image from Dexcom]Terumo announced today that the Japanese medical insurance system expanded reimbursement coverage for the Dexcom G6 CGM.

Japan’s medical insurance system introduced a new category titled “C150.” It makes a wider range of people with diabetes eligible to receive reimbursement for the G6 continuous glucose monitor (CGM) in Japan.

Dexcom develops and manufactures the current-generation G6 CGM. It offers the next-generation Dexcom G7 CGM in the UK, Ireland, Germany, Austria and Hong Kong. U.S. approval could come soon, too. Terumo markets the G6 in Japan.

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

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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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Dexcom stock rises on Q3 results following G7 international rollout

Dexcom (Nasdaq:DXCM) shares are up today — a day after it reported third-quarter results that came in ahead of the consensus forecast.

DXCM shares were up more than 17% at $118.78 by the afternoon today. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down more than 1%.

The San Diego-based continuous glucose monitoring (CGM) technology developer posted profits of $101.2 million. That amounts to 24¢ per share on sales of $769.6 million for the three months ended Sept. 30, 2022.

Adjusted to exclude one-time items, earnings per share came in at 28¢ apiece. That registers 4¢ ahead of expectations on Wall Street. Revenues beat The Street as well after analysts projected sales of $750.93 million.

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

This story originally ran on Oct. 27, 2022. Updated Oct. 28 with the next-day stock price. 

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How Dexcom uses wearables to deliver differentiated diabetes management

Dexcom has worked with Garmin to create apps on Garmin devices that use real-time CGM data. [Image from Garmin]Dexcom (Nasdaq:DXCM) is one of the leaders in the diabetes technology space with its continuous glucose monitoring (CGM) technology.

The company’s current-generation Dexcom G6 CGM remains one of the biggest players in the CGM space. Meanwhile, its next-generation Dexcom G7 CGM has already launched in a number of countries overseas. The wearable device — which features a 60% size reduction from G6 — still awaits FDA clearance.

Dexcom sits among a number of companies developing wearables for helping people manage their diabetes. The company’s SVP for Product, Global Marketing, Apurv Kamath, spoke today at AdvaMed’s The MedTech Conference on the impact of wearables.

While he focuses on diabetes management, the panel on which he sat covered a range of uses for wearables in medtech. It featured Alissa Hsu Lynch, global lead for medtech…

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Analysts: Abbott, Dexcom to benefit from proposed CMS decision on CGMs

Left, the Dexcom G7. Right, the Abbott FreeStyle Libre 2. [Images from Dexcom and Abbott]Analysts see a new proposed local coverage determination (LCD) from CMS as a potential boost for Dexcom (Nasdaq:DXCM) and Abbott (NYSE:ABT).

The Centers for Medicare and Medicaid Services (CMS) yesterday published the LCD modifying coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.

Abbott and Dexcom both develop market-leading CGMs. The Dexcom G7 recently launched outside the U.S. and the company hopes for FDA clearance early next year. Meanwhile, Abbott recently announced positive data backing its FreeStyle Libre 2 system.

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Dexcom G7 launches in a handful of countries outside the U.S.

[Image from Dexcom]Dexcom (Nasdaq:DXCM) announced today that it made the next-generation Dexcom G7 available in a number of countries outside the U.S.

The San Diego-based company now offers Dexcom G7 in the UK, Ireland, Germany, Austria and Hong Kong. Availability covers people with diabetes aged two years and older. The launch marks the first major milestone in the availability of the continuous glucose monitor (CGM).

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7 innovative digital health offerings to treat diabetes

MIT engineers are working on an app that that identifies and quantifies food content, which can aid in carbohydrate counting for people with diabetes. [Image from MIT News] From using your smartphone to track data to reversing your diabetes altogether, these digital health technologies stand out.

Advances in treatments for diabetes never stop coming. Whether that be in the form of insulin pumps or continuous glucose monitors, we’ve seen plenty.

Moving away from the physical device, innovations in the digital diabetes space continue to impress. Digital therapeutics, artificial intelligence- and cloud-based offerings and more comprise an intriguing list of technologies.

Here are seven digital offerings aimed at treating diabetes that you might want to keep an eye on:

1. Digital therapeutics for diabetes

Digital therapeutics is an ever-growing space capable of treating a range of diseases and conditions. That reach extends to diabetes, as shown by companies…

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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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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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