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Dexcom aims to bring new glucose sensor to the market for people who don’t use insulin

Dexcom (Nasdaq:DXCM) today unveiled its strategy to expand access to its glucose-sensing technology for millions around the world.

San Diego-based Dexcom held an Investor Day event in which it revealed plans to bring a new product to market in the U.S. in 2024. The company designed its new product for people who don’t use insulin — approximately 70% of Americans with diabetes.

Dexcom said it plans for its new product to feature a 15-day sensor and a cash-pay option. The company wants to offer a new software experience tailored for those not on insulin.

Earlier this year, Dexcom Chair, President and CEO, Kevin Sayer, hinted at potential new avenues when speaking to Drug Delivery Business News. He explained that the company wanted to broaden its focus, even revising its mission statement. Dexcom updated its mission — enabling people to take control of diabetes — by changing “diabetes” to “health.”

The top IVD innovation news stories of 2023 — so far

[Image courtesy of the National Cancer Institute via Unsplash]This year is proving to be another important year for innovation in the in vitro diagnostic (IVD) space.

According to the FDA, IVD devices are tests performed on samples taken from the human body. They could be everything from blood tests processed in labs to home COVID-19 or pregnancy tests to continuous glucose monitors using tiny sensors stuck under to skin to measure blood glucose — and much more.

Here are five IVD innovation stories that have caught our attention so far this year:

5. Hologic wins FDA clearance for COVID-flu-RSV assay

Last winter, the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV. So it was welcome news in May when Hologic announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The news came months after the FDA granted an emergency use authorization for a COVID/flu/RSV test from BD.

Read the full story a…

Dexcom study shows diabetes’ impact on mental health

The Dexcom G6. [Image courtesy of Dexcom]A new study commissioned by Dexcom (Nasdaq:DXCM) + found that diabetes has significant negative effects on mental health.

The study revealed that 84% of people surveyed agree that having diabetes can negatively impact mental health. It also demonstrated that nearly all participants (91%) believe technology enables a balanced lifestyle while managing diabetes.

Dexcom, a maker of continuous glucose monitor (CGM) technology, announced results ahead of the UK’s Diabetes Awareness Week. Censuswide conducted this research in April 2023 on behalf of the company. It included responses from 1,000 nationally representative UK respondents aged 16 years and up living with diabetes.

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

Design firm Delve makes first acquisition under new owner

Delve developed a prototype of the SC360 proton-beam therapy system for ProNova. [Photo courtesy of Delve]

Delve announced its acquisition of Boston-based digital innovation and design firm Altr this week.

Madison, Wisconsin–based Delve said Altr is its first acquisition under the ownership of private equity firm Trinity Hunt Partners, which purchased Delve in May 2021 and merged it with product design consultancy firm Bresslergroup.

“Almost two years ago to the day, we announced our intention to build a company that could be considered the world’s best end-to-end product innovation firm,” Delve President Andrew Weiman said in a news release yesterday. “With Altr, we take another giant step forward. Much more to come.”

The deal comes as medical device developers are increasingly integrating digital offerings into their devices. Delve said the Altr deal “strength…

Dexcom touts more clinical evidence for G6 CGM in Japan

The G6 platform. [Image from Dexcom]Dexcom (Nasdaq:DXCM) announced that it showcased its Dexcom G6 CGM at the 66th Annual Meeting of the Japan Diabetes Society.

G6, now the previous-generation version of the company’s CGM after the launch of the G7, uses a small, wearable sensor. It also features a transmitter, continuously measuring and sending glucose levels wirelessly to a smart device or receiver. The system enables people with diabetes to receive real-time glucose data without needing to scan or prick their finger.

Dexcom said it showcased the latest clinical evidence at the meeting in Kagoshima, Japan. The company received a non-adjunctive decision and reimbursement expansion in Japan recently based on the clinical data it provided.

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

UK study backs Dexcom real-time CGM

The Dexcom One platform. [Image from Dexcom]Dexcom (Nasdaq:DXCM) announced today that a published study in the UK supports its real-time continuous glucose monitoring (rtCGM).

San Diego-based Dexcom published its study in Diabetes Therapy. It’s titled “Cost-Effectiveness of a Real-Time Continuous Glucose Monitoring System Versus Self-Monitoring of Blood Glucose in People with Type 2 Diabetes on Insulin Therapy in the UK.”

The study produced a long-term health economic analysis using the IQVIA CORE Diabetes Model. This allows the calculation of long-term outcomes based on the best data currently available. It establishes the cost-effectiveness for funding Dexcom rtCGM technology against testing with fingerprints.

According to Dexcom, the analysis suggests that rtCGM use results in significant improvements in HbA1c. It also demonstrated reductions in long-term diabetes-related complications and emergency department visits.

Dexcom proposes $1B offering of convertible senior notes

Dexcom (Nasdaq:DXCM) today announced that it intends to offer $1 billion in convertible senior notes due in 2028.

The continuous glucose monitor (CGM) maker made its private placement to persons reasonably considered qualified institutional buyers. San Diego-based Dexcom also plans to grant the initial purchasers of the notes an option to buy more. Those options fall within a 13-day period from, and including, the date of first issuance, for up to an additional $150 million.

Dexcom said in a news release that its notes are senior, unsecured obligations with interest payable semi-annually in arrears. The notes mature on May 15, 2028, unless earlier converted, repurchased or redeemed.

Dexcom earmarked a portion of its net proceeds to pay the cost of capped call transactions. If the initial purchasers exercise their option to buy additional notes, the company intends to use a portion of those proceeds to enter into additional capped call transactions.

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Dexcom grows revenues 18% in Street-beating Q1, raises guidance

Dexcom (Nasdaq:DXCM) today announced that it’s raising its 2023 financial guidance following strong first-quarter financial results.

Shares of DXCM dipped 3.7% to $119 apiece after the market closed. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up 0.2%.

The San Diego-based continuous glucose monitor technology developer posted profits of $48.6 million. That equals 12¢ per share on sales of $741.5 million for the three months ended March 31, 2023.

Dexcom reported a 50% bottom-line slide on sales growth of 17.9%. The company attributed sales growth to strong new customer additions. Dexcom noted this continues to drive revenue growth as awareness of real-time CGM increases.

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

Dexcom G6 picks up coverage expansion in Canada

The Dexcom G6. [Image courtesy of Dexcom]Dexcom (Nasdaq:DXCM) today said it applauds an expansion of coverage for continuous glucose monitoring (CGM) systems in Canada.

The coverage expansion comes through the Non-Insured Health Benefits (NIHB) program. It now enables any client managing diabetes with insulin to access the standard of care.

Dexcom said its G6 CGM is now at its most accessible point ever under the NIHB program. It marks the highest degree of diabetes management possible for First Nations and Inuit peoples. According to the company, the expansion brings people in Canada one step closer to accessing the technology they need.

This expansion in Canada follows a major Medicare coverage win in the U.S. for Dexcom and CGM makers alike. Earlier this year, the company had another Canadian coverage win, too. Dexcom said in March that all people with type 1 and type 2 diabetes in Manitoba, Canada, meet eligibility criteria for its G6 CGM.

Access in parts of Canada expands for Dexcom G6 CGM

The Dexcom G6. [Image courtesy of Dexcom]Dexcom (Nasdaq:DXCM) announced that all people with type 1 and type 2 diabetes in Manitoba, Canada, meet eligibility criteria for its G6 CGM.

As of the company’s announcement, Manitoba is the only province in Canada that does not require an application for coverage preapproval. That means improved access for patients and a reduced workload for prescribers.

Expanded coverage establishes Manitoba as the leader in coverage for real-time continuous glucose monitoring (rtCGM) among Canadian provinces.

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

Expanded Medicare coverage for CGM to go into effect next month

Left, the Dexcom G7. Right, the Abbott FreeStyle Libre 2. Both expect to benefit from the latest Medicare win. [Images from Dexcom and Abbott]The Centers for Medicare & Medicaid Services today published a final local coverage determination (LCD) expanding coverage for CGMs.

New, expanded coverage of continuous glucose monitors (CGMs) under Medicare go into effect in April.

CMS first published the LCD modifying coverage criteria for CGMs in October. The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia. The proposal eliminates the requirement for frequent adjustments of the patient’s insulin treatment regimen. This falls on the basis of glucose measurement testing.

The finalized version changed some language on the criteria. It amended the line saying “the beneficiary is insulin-treated with at least one daily administration of insulin” to, simply, “the beneficiary is …

Medtech jobs: The world’s largest medical device companies are hiring

Medical device companies are trying to fill thousand of medtech jobs. [Photo by ijeab – stock.adobe.com]

The world’s largest medical device companies are still hiring for medtech jobs despite layoffs in tech and other industries.

Medtech developers — and medtech jobs — are resilient, with the industry’s COVID-19 pandemic performance only bolstering its recession-proof reputation.

That’s not to say there haven’t been job cuts in medtech, led by thousands of layoffs at Philips as it struggles with a massive recall of deadly respiratory devices. But most medical device manufacturers are still hiring, and in some cases they can’t attract enough candidates to fill every vacancy in a tight labor market.

Stryker, for example, grew to approximately 51,000 employees as of the end of 2022, increasing its headcount by nearly 11 percent last year. Boston Scientific reported nearl…