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Dexcom stock slides despite Q1 beats, sales guidance increase

Dexcom (Nasdaq: DXCM) + shares took a hit after hours today on first-quarter results that came in ahead of the consensus forecast on Wall Street.

Shares of DXCM dipped about 7% to $128.40 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 down 1%.

The San Diego-based continuous glucose monitor maker reported profits of $146.4 million. That equals 36¢ per share on sales of $921 million for the quarter ended March 31, 2024. Dexcom more than tripled its bottom line on a sales uptick of 24.2%.

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

May 2024 edition: Intuitive’s DV5, pediatric device design and diabetes tech

The Intuitive da Vinci 5’s top design changes: ‘This is groundbreaking for robotic surgery’ Small patients, big design challenges: Pediatric device experts guide engineers on solutions The biggest diabetes tech news out of ATTD 2024 5 things that will shape surgical robotics over the next decade All eyes on Intuitive’s da Vinci 5

It’s hard to think of a product update with higher stakes for a device developer — and the medtech industry — than Intuitive Surgical’s da Vinci 5 robotic-assisted surgery system.

All eyes are on the world’s leading surgical robotics developer as it rolls out the next generation of its flagship system after winning FDA clearance. Will the new features and long list of design changes put even more distance between surgical robotics and conventional laparoscopy? Is Intuitive advancing its technology rapidly enough to maintain or expand its lead ahead of larger device manufacturers, maturing surgical robotics developers and fas…

Study highlights benefits of automated insulin delivery for children in UK

The MiniMed 780G with Guardian 4 and a 7-day infusion set. [Image courtesy of Medtronic]A study in the UK demonstrated significant improvements in HbA1c for users of automated insulin delivery technologies.

This comes on the heels of a UK NHS initiative to provide tens of thousands of children and adults with type 1 diabetes in the country with an artificial pancreas.

The study aimed to assess the efficacy of hybrid closed-loop systems at 12 months. It looked at HbA1c, time in range, hypoglycemia frequency and quality of life measures among children and young people with type 1 diabetes.

Investigators conducted the study between Aug. 1, 2021, and Dec. 10, 2022 across eight pediatric diabetes centers in England. They utilized three automated insulin delivery systems, all fully funded by the NHS:

Tandem t:slim X2 pump with Control IQ technology in combination with the Dexcom G6 CGM. Medtronic MiniMed 780G with Guardian 4. Ypsomed YpsoPump with CamDiab Ca…

Non-insulin, basal CGM use exceeds analysts’ expectations, Dexcom and Abbott to benefit

Left, the Dexcom G7. Right, the Abbott FreeStyle Libre 2. [Images from Dexcom and Abbott]William Blair analyst Margaret Kaczor reported surprise at the increase in users of CGM within the non-insulin and basal insulin populations.

Kaczor expects Dexcom and Abbott to benefit from the trend with their next-generation CGM offerings after meetings with both companies’ management.

Both companies launched next-gen CGMs in recent years (Dexcom G7 and Abbott FreeStyle Libre 3). Dexcom also began rolling out its Stelo over-the-counter non-insulin CGM and Abbott has its Lingo non-insulin biowearable coming to the U.S. soon.

According to Kaczor, the number of non-insulin patient adds in 2023 proved surprising and came in above expectations. William Blair estimates nearly 300,000 new non-insulin CGM users, compared to a projection of 200,000. She sees this as an additive to the still-underpenetrated opportunity in the insulin-using diabetic patient population. Read more

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…