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The biggest diabetes tech news out of ATTD 2024

This is a screenshot from a video demonstrating the features of the new Roche Accu-Chek SmartGuide CGM at ATTD 2024.

Every year, the diabetes community comes together for the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD).

In the 17th installment at the start of this month, some of the biggest names shared new studies and technologies set to advance the diabetes space. Dexcom, Abbott, Medtronic and more contributed on their end, while some new technologies are coming to the fore as well.

Here are the biggest stories from this year’s ATTD conference in Florence, Italy. (You can also check out the biggest news out of ATTD in 2023 and 2022.)

Dexcom’s direct-to-watch feature

Dexcom announced at ATTD that it introduced a direct-to-Apple-Watch feature for its G7 continuous glucose monitor (CGM) users.

The company plans a phased launch for all G7 iOS users everywhere by the end of the second quarter of …

FDA clears first over-the-counter CGM from Dexcom

The Stelo glucose monitor. [Image courtesy of Dexcom]Dexcom (Nasdaq: DXCM) + announced today that the FDA cleared its Stelo glucose biosensor that does not require a prescription.

This marks the first FDA clearance for a continuous glucose monitoring (CGM) technology for over-the-counter use. In January, Dexcom first announced that it submitted the new Stelo sensor to the FDA for review at the end of last year. The San Diego-based company designed it specifically for people with type 2 diabetes who do not use insulin.

Dexcom estimates approximately 25 million people in the U.S. with type 2 diabetes who don’t use insulin but could benefit from CGM use.

The small, wearable sensor is indicated for those 18 years and older who are not using insulin therapy. Worn on the back of the arm, the sensor provides insights directly to a user’s smartphone.

Get the full story at our …

Dexcom announces direct-to-watch feature for G7 CGM, strong automated insulin delivery outcomes

The ONE+ system, featuring a sensor, reader, smartphone, smartwatch and applicator. [Image courtesy of Dexcom]Dexcom (Nasdaq: DXCM) + announced today that it introduced a direct-to-Apple-Watch feature for its G7 continuous glucose monitor (CGM) users.

The company plans a phased launch for all G7 iOS users everywhere by the end of the second quarter of this year. This means G7 soon becomes the only CGM system that can connect directly to Apple Watch without needing to carry an iPhone. Those who use G7 can access this feature as soon as it launches in their country.

On top of the watch feature, Dexcom announced positive data backing its CGMs and their connectivity to automated insulin delivery (AID). Additionally, the company launched Dexcom ONE+ in new geographies and has more data backing its technology.

The company plans to present much of this evidence and data at ATTD this week in Florence, Italy.

These diabetes devices are set to launch in 2024

The Stelo glucose monitor. [Image courtesy of Dexcom]The diabetes space continues to innovate and it doesn’t look like that’s stopping any time soon, with 2024 set to be another banner year.

At the end of 2023, we compiled a list of the 10 biggest diabetes technology stories of the year. Some of those stories didn’t end in 2023, though, as a few major product launches loom on the horizon.

New CGMs, insulin pumps and combinations of the two will all be coming to the market over the next several months. Here are some of the most highly-anticipated product launches set to take place in the diabetes space in 2024 — plus some of the tech that’s already launched:

Diabetes launches on the horizon Medtronic’s new pump-sensor combo

In January, Medtronic won CE mark for its MiniMed 780G automated insulin delivery system with the Simplera Sync sensor.

The MiniMed 780G with the Simplera Sync CGM and accompanying devices. [Image courtes…

Insulet begins limited rollout of Omnipod 5 with Dexcom G7, grows sales by 38% in Q4

The Insulet Omnipod 5 [Photo courtesy of Insulet]Insulet (Nasdaq: PODD) + announced today that it began a limited market release of the Omnipod 5 with the Dexcom G7.

This marks the latest integration of Dexcom’s next-generation CGM into automated insulin delivery technology. Omnipod 5, Insulet’s newest patch pump offering, previously worked with the G6 in the U.S. It also recently integrated the system with Abbott’s FreeStyle Libre 2 Plus in Europe.

Insulet previously suggested that G7 integration would come early in 2024. In the company’s fourth-quarter earnings report — which included Street-beating results — the company confirmed the initial limited rollout began recently.

Shares of PODD fell nearly 7% at $183.50 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day up 0.6%.…

Dexcom says revenues could grow 20% in 2024

Dexcom (Nasdaq: DXCM) + shares dipped after hours on fourth-quarter results that came in ahead of the consensus forecast.

Shares of DXCM fell 1.6% at $125 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day up 0.2%.

The San Diego-based continuous glucose monitor (CGM) maker posted profits of $256.3 million. That equals 62¢ per share on sales of $1.03 billion for the three months ended Dec. 31, 2023. Dexcom nearly tripled its bottom line on sales growth of 26.9%.

Adjusted to exclude one-time items, earnings per share totaled 50¢, landing 7¢ ahead of expectations on Wall Street. Sales narrowly beat the forecasts for $1.02 billion in revenue.

The company highlighted volume growth and new customer additions as the primary growth driver for revenues. Dexcom says awareness of real-time CGM conti…

Dexcom launches new ONE+ CGM system in Europe

The ONE+ system, featuring a sensor, reader, smartphone, smartwatch and applicator. [Image courtesy of Dexcom]Dexcom (Nasdaq: DXCM) + announced today that it launched its latest continuous glucose monitor (CGM) system, the Dexcom ONE+.

The San Diego-based company began rolling out the system in Spain, Belgium and Poland. It plans for a launch next week in the Netherlands, too. In some countries, the system replaces the previous-generation Dexcom One sensor.

ONE+ uses Dexcom’s established sensor design, with the company incorporating feedback from users and healthcare professionals to build it. The company said this ensured an easy-to-use, highly effective CGM experience for people treating type 1 or type 2 diabetes with insulin.

This version of the platform utilizes the latest-generation G7 sensor, while the previous version used the G6. CEO Kevin Sayer told Drug Delivery Business News last month that he expe…

The top IVD and diabetes tech stories of 2023

The G7 CGM helps users manage their diabetes. [Image courtesy of Dexcom]Over the course of 2023, the medtech industry produced another impressive year of innovation, with news coming from a variety of spaces.

Chiefly among those were diabetes technologies and in vitro diagnostics (IVDs). We saw regulatory nods, product launches, funds raised and mergers fall apart.

Looking at those two spaces in particular, here are five diabetes and IVD stories that caught our attention in 2023:

5. Cytovale raises $84M Series C for sepsis diagnostic

In November, Cytovale announced that it raised $84 million in a Series C funding round to support its rapid sepsis diagnosis test. Cytovale earmarked funds to support the wider expansion of this testing technology.

The FDA cleared the IntelliSep test, which aids hospital emergency departments and health systems, in January. IntelliSep provides test results in under 10 minutes, offering actionable answers using standard b…

Dexcom breaks ground on manufacturing facility in Ireland

The Stelo glucose monitor. [Image courtesy of Dexcom]Dexcom (Nasdaq: DXCM) + announced today that it broke ground on a new state-of-the-art manufacturing facility in Ireland.

The San Diego-based continuous glucose monitor (CGM) maker announced plans to invest $325 million in Athenry last May. Breaking ground on the facility marks the first steps toward bringing more than 1,000 jobs to the area. The company expects the factory to be completely built by the second half of 2025.

Dexcom EVP of Global Operations, Barry Regan, explained what attracted the company to the growing medtech hub last year. The company says its investment represents one of the biggest single private sector investments ever in the West of Ireland. Dexcom is the latest CGM maker to break ground in Ireland, as Abbott began construction on a Kilkenny FreeStyle Libre manufacturing plant last April.

Get the full story at o…

The biggest stories from the 2024 J.P. Morgan Healthcare Conference

Medtronic’s Geoff Martha, Dexcom’s Kevin Sayer and J&J’s Joaquin Duato spoke at this year’s J.P. Morgan Healthcare Conference.

Some of the biggest names in medtech came together this week at the J.P. Morgan Healthcare Conference. They shared updates on financial progress, operational changes and new products, among other things.

Medtronic shared details on plans to restore earnings power, while Abbott highlighted the success of its FreeStyle Libre system. Shockwave Medical outlined its plans for growth, while Dexom

Here are some of the biggest stories to come out of this year’s edition of the J.P. Morgan Healthcare Conference.

Medtronic focuses on earnings power while shifting operational setup

Medtronic Chair and CEO Geoff Martha’s presentation centered on profits for the medtech giant.

“Our top priority is restoring our earnings power — full stop,” he said. “We continue to be this mission-driven company th…

The most important medtech leadership changes of 2023

Former Johnson & Johnson EVP and MedTech Worldwide Chair Ashley McEvoy [Photo courtesy of Johnson & Johnson]

From hirings and firings to promotions, resignations and surprising shake-ups, these were the most important medtech leadership changes of the year.

By Associate Editor Sean Whooley and Managing Editor Jim Hammerand

The leadership change at Johnson & Johnson MedTech was a surprising shift that ended up as the year’s biggest medtech leadership change of 2023.

In October, J&J EVP and J&J MedTech Worldwide Chair Ashley McEvoy announced her resignation from the world’s second-largest device manufacturer. She’s staying on into the first quarter of 2024 while her successor, Tim Schmid, gets settled into his new role.

Schmid, a 30-year J&J vet who was most recently company group chair of J&J MedTech Asia Pacific, said he’s “committed to building ev…

How Dexcom designed a new “life-changing” sensor for even more people with diabetes

The Stelo glucose monitor. [Image courtesy of Dexcom]Dexcom (Nasdaq: DXCM) + Chair, President and CEO Kevin Sayer says that, in 2019, he gave a speech announcing the company’s first $1 billion year. This week, Sayer announced the continuous glucose monitor maker’s first $1 billion quarter.

Plenty of innovation has bolstered that progress over the past few years. Nearly one year ago, Dexcom launched its next-generation G7 CGM. Last month, the company announced new integrations with automated insulin delivery systems from Tandem and Beta Bionics.

Now, the company can expect even more growth, thanks to its next major product launch.

Dexcom announced that it submitted its new sensor, Stelo, to the FDA for review. The company expects to launch Stelo, which is designed for people with type 2 diabetes who don’t use insulin, this coming summer.

“Our mission is to empower people to control hea…