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Dexcom to announce U.S. G7 launch in Super Bowl commercial with Nick Jonas

Nick Jonas holds the next-generation G7 CGM. [Image courtesy of Dexcom]Dexcom (Nasdaq:DXCM) today unveiled its upcoming Super Bowl commercial that announces the U.S. launch of its next-generation Dexcom G7 CGM.

The ad, set to run during the second quarter of Super Bowl LVII on Feb. 12, features musician, actor and philanthropist Nick Jonas. Jonas lives with type 1 diabetes and uses Dexcom’s continuous glucose monitors (CGMs).

Dexcom received FDA clearance for the next-generation G7 in December 2022. The company said at the time that it planned for a launch in “early 2023. COO Jake Leach told Drug Delivery Business News shortly after clearance that the company intended to initiate a full launch without any limited efforts.

CEO Kevin Sayer later told DDBN that the company wouldn’t be taking the launch lightly.

“That launch is not going to be bashful,” Sayer said. “We’re going to be aggressive about it.”

What to expect in diabetes care in 2023

[Image courtesy of Walmart]

After a banner year for diabetes technology in 2022, there’s still plenty to look forward to in 2023.

Throughout 2022, we saw a wide range of advancements in diabetes technology. We saw launches for next-generation technologies, exciting clinical trial results, and rumored spinouts and acquisitions.

You can read all about the biggest diabetes stories of 2022 here.

There’s plenty to look forward to in the diabetes space in the months ahead. Here are a few things worth keeping an eye on.

CMS decision could benefit CGMs

In October, The Centers for Medicare and Medicaid Services (CMS) published a new local coverage determination (LCD). That LCD modified coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.

Analysts suggested at the time …

The year ahead in diabetes care: what to expect in 2023

[Image courtesy of Walmart] After a banner year for diabetes technology in 2022, there’s still plenty to look forward to in 2023.

Throughout 2022, we saw a wide range of advancements in diabetes technology. We saw launches for next-generation technologies, exciting clinical trial results, rumored spinouts and acquisitions and more.

You can read all about the biggest diabetes stories of 2022 here.

As we embark on a new year in 2023, there’s still plenty to look forward to in the diabetes space. Here are a few things worth keeping an eye on.

CMS decision could benefit CGMs

In October, The Centers for Medicare and Medicaid Services (CMS) published a new local coverage determination (LCD). That LCD modified coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.

Analysts suggested at the time that the decision marked a win for …

How Dexcom aims to extend its mission beyond diabetes

Kevin Sayer. [Image from Dexcom’s website] CEO Kevin Sayer explains how, following the launch of the next-generation Dexcom G7, the company is looking toward the future.

Dexcom (Nasdaq:DXCM) ended 2022 strong, receiving FDA clearance for its next-generation G7 continuous glucose monitor (CGM). With a U.S. launch imminent, the company could keep its efforts centered on the diabetes space.

Instead, the company plans to broaden its focus even wider.

“We’ve revised our mission statement,” Sayer told Drug Delivery Business News. “In the past, we always talked about enabling people to take control of diabetes. We’ve changed diabetes to health. We’re enabling people to take control of their health because metabolic health and glucose values and the information we can provide are very much synonymous.”

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

Dexcom appoints former J&J exec as CCO, sets 2023 guidance

New Dexcom CCO Teri Lawver. [Image from Janssen Pharmaceutical Company website]Dexcom (Nasdaq:DXCM) announced today that it appointed Teri Lawver to its newly created role of chief commercial officer (CCO).

Lawver’s position oversees the global commercial organization at the continuous glucose monitoring (CGM) technology developer. She holds responsibility for global sales, marketing and customer experience.

Before joining San Diego-based Dexcom, Lawver spent two decades in a variety of leadership roles at Johnson & Johnson. Her positions spanned the medical device, consumer medtech and pharmaceutical sectors. Most recently, she served as worldwide VP, immunology at J&J’s Janssen Pharmaceutical Companies.

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

At-home predictive care and the shifting patient experience

The eMed platform connects patients with telehealth providers for home testing. [Photo courtesy of eMed]

These medtech developers are advancing remote patient monitoring, virtual care, and AI predictive care.

Robin Farmanfarmaian

The combination of remote patient monitoring (RPM), virtual care and AI predictive care is changing the patient experience. Instead of the occasional clinic visit, people can interact with their healthcare daily and on-demand.

Here are a few of the medtech startups advancing remote, continuous and predictive care. Together, these companies enable truly personalized care, tailored to someone in their daily life and environment.

Remote patient monitoring (RPM)

There are many technology devices that have cleared the FDA and qualify as remote physiologic monitoring under the Medicare CPT codes. Medicare also has remote therapeutic monitoring CPT codes for musculoskeletal …

The 10 biggest diabetes tech stories from 2022

Some of the biggest diabetes technology developments in 2022. These include the Dexcom G7 (top left), Insulet Omnipod 5 (bottom left), Senseonics Eversense E3 (top right) and Abbott FreeStyle Libre 3 (bottom right. 2022 represented a landmark year for next-generation diabetes technologies. Here are the biggest stories from the past year.

Some companies picked up major regulatory nods. Others experienced major regulatory setbacks.

Partnerships were formed and ended, while mergers and acquisitions came and went. There were many stories to choose from, but here are 10 big ones that stood out:

Dexcom G7 receives FDA clearance

The long-awaited regulatory nod for Dexcom’s next-generation continuous glucose monitor (CGM) finally came in December.

Some suggested that San Diego-based Dexcom may pick up clearance as soon as summer 2022. However, a software change recommended by the FDA, plus COVID-19-related backlog, delayed proceedings.

Dexcom COO Ja…

DeviceTalkers assemble for the final Newsmakers of 2022

In this episode, your diligent team of DeviceTalkers assembled to review our Top 10 events, trends and newsmakers of 2022.

Executive Editor Chris Newmarker, Pharma Editor Brian Buntz, Managing Editor Jim Hammerand, Senior Editor Danielle Kirsh and Associate Editor Sean Whooley joined me, DeviceTalks Editorial Director Tom Salemi, for the latest DeviceTalks podcast.

We’ve got some highs — robots, diabetes — and some lows — supply chain, recalls — and a whole lot of interesting things in between. All-in-all, we’re bullish on what’s to come in 2023! And we only mentioned COVID-19 once.

Companies mentioned in our wide-ranging discussion include Abbott, Abiomed, Ambu, Becton Dickinson, Boston Scientific, CMR Surgical, Dexcom, embecta, Intuitive, Johnson & Johnson Medtech, Medtronic, Neuralink, Philips, Senseonics, Stryker, Synchron, Vicarious Surgical, Zimmer Biomet, ZimVie and many more.

You can listen to other DeviceTalks Podcast Network shows at…

How this medtech molder is navigating challenging times

Mark Gomulka is the CEO of Westfall Technik. [Photo courtesy of Westfall Technik]

5 questions with Westfall Technik CEO Mark Gomulka

Mark Gomulka has had a busy first year as CEO of plastics contract manufacturer Westfall Technik.

Gomulka joined Las Vegas–based Westfall Technik in September 2021 after five years at Flex and 15 years at Nypro before that.

Formed in 2017 with 20 acquisitions closed and more on the way, the end-to-end plastics manufacturer’s revenue is now around $400 million per year with approximately 20% year-over-year sales growth, Gomulka said.

“I’m having fun doing this, because I think we’re creating something,” Gomulka said in an interview. “We have 2,500 employees. That means we serve 2,500 families. And most importantly, we have incredible customers that took a gamble on us and continue to take a gamble on a company that five years ag…

FDA clearance for Dexcom G7 marks ‘a huge leap’ forward, COO Jake Leach says

[Image from Dexcom] After plenty of anticipation — and a bit of waiting — the next-generation Dexcom G7 continuous glucose monitor is finally here.

In mid-2021, Dexcom (Nasdaq:DXCM) CEO Kevin Sayer told Drug Delivery Business News that its next-generation CGM would be “wonderful.” At the time, he said enthusiasm over the Dexcom G7 sat at an all-time high.

About 18 months later, the Dexcom G7 finally arrived in the U.S. The FDA granted clearance to the device earlier this month.

The Dexcom G7 demonstrated exciting results in glucose monitoring in a number of clinical trials. One study highlights its accuracy, and another demonstrates success with pediatric users. Dexcom announced its international rollout for G7 in October. The system won CE mark in March.

In order to pick up FDA clearance, Dexcom had to apply software tweaks based on FDA feedback earlier this year. This threw a wrench in the expected timelines for FDA 510(k) clearance and the…

The biggest medtech personnel moves in 2022

Some of the largest companies in medtech have promoted, replaced or removed leaders in recent months.

In July, Medical Design & Outsourcing compiled a list of the biggest personnel changes in the first half of 2022. Those included hirings, firings, promotions and retirements of CEOs, presidents and and other business leaders across the medtech industry.

The latter half of the year has brought even more changes. To close out 2022 and prepare for 2023, here are more of the year’s biggest medtech moves — and some updates since the news first broke.

Butterfly Network CEO steps down

Todd Fruchterman

On Dec. 6, Butterfly Network (NYSE:BFLY) announced that it reached a mutual agreement with Dr. Todd Fuchterman to step down as president and CEO. Fruchterman also left Butterfly’s board of directors.

Fruchterman oversaw Butterfly’s development of artificial intelligence-based ha…

Dexcom partners with Green Shield, Health Depot on digital diabetes management service

The Dexcom G6. [Image courtesy of Dexcom]Dexcom (Nasdaq:DXCM) announced today that it partnered with Green Shield and The Health Depot to expand access to the Dexcom G6.

The partnership offers Green Shield plan members convenient access to the G6 real-time continuous glucose monitor (rtCGM). It combines this access with virtual diabetes coaching support.

Green Shield plan members eligible for G6 coverage can register for the new Digital Diabetes Care program. It offers them exclusive access to convenient and coordinated diabetes management support services in Canada.

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