Tandem Diabetes Care Archives - Page 2 of 6

Tandem provides pathway to transition to new insulin pump platform

The Mobi automated insulin pump with the accompanying mobile app. [Image courtesy of Tandem Diabetes Care]Tandem Diabetes Care (Nasdaq:TNDM) announced today that it made a new, limited-time offer for its Tandem Choice technology access program.

The San Diego-based company’s program provides new and renewing, eligible users of its insulin pump a pathway to its new offerings. Users of the t:slim X2 insulin pump in the U.S. can use the program to move toward owning a Tandem Mobi system for $199.

The FDA cleared the Mobi automated insulin delivery (AID) system earlier this month. Tandem Diabetes Care expects to begin a limited launch later this year, with general availability slated for early 2024.

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

Tandem resets 2023 guidance due to reduced sales visibility from new product disruption

Tandem Diabetes Care (Nasdaq:TNDM) shares took a hit on second-quarter results that included amended full-year financial guidance.

Changes to the automated insulin delivery technology maker’s outlook reflect updates to its portfolio and reduced visibility on sales for the near future.

Shares of TNDM fell 15% to $27.19 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 0.8%.

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

8 drug delivery innovations you should know

Innovations in drug delivery never stop and, over the past 12 months or so, a wide variety have come under the spotlight.

Constant progress continues in the diabetes space, both in the form of insulin delivery and other drug delivery methods. Elsewhere, we see implants, patches, syringes and more showcasing just how many ways we can deliver therapeutics.

About a year ago, we clued in readers to a list of six drug delivery innovations they should know. Here, we provide a couple of updates on those and try to introduce a few more developments that you should know:

The latest in automated insulin delivery tech

Automated insulin delivery represents one of the most high-profile markets in drug delivery, with the technology providing potentially life-saving therapy for people with diabetes.

The Mobi automated insulin pump with the accompanying mobile app. [Image courtesy of Tandem Diabetes Care]Last year’s roundup included the already FDA-cleared Omn…

FDA clears Tandem Diabetes Care’s Mobi durable automated insulin pump

The Mobi automated insulin pump with the accompanying mobile app. [Image courtesy of Tandem Diabetes Care]Tandem Diabetes Care (Nasdaq:TNDM) announced today that the FDA cleared its Tandem Mobi automated insulin delivery (AID) system.

Clearance covers people with diabetes ages six and up, expanding the Tandem portfolio of products.

San Diego-based Tandem says Mobi, which is fully controllable from a mobile app, is the world’s smallest durable AID system.

Mobi features a 200-unit insulin cartridge and an on-pump button to provide an alternative to phone control for insulin boluses. It comes in at less than half the size of the existing Tandem pump system, the t:slim X2 pump.

According to the company, it can fit in a coin pocket, clip to clothing or go on the body with an adhesive sleeve.

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

Tandem stock dips after hours on Q1 misses as it teases 2023 product launches

Tandem Diabetes Care (Nasdaq:TNDM) shares ticked down after hours today on first-quarter results that fell shy of the consensus forecast.

Shares of TNDM fell 9.9% to $36 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up 0.3%.

The San Diego-based automated insulin delivery technology developer posted losses of $123.9 million. That amounts to $1.92 per share on sales of $169.4 million for the three months ended March 31, 2023.

Tandem reported a massive bottom-line slide into the red from losses of $14.7 million this time last year. The company also saw its sales decline at a rate of 3.7%.

Adjusted to exclude one-time items, losses per share totaled 63¢. That fell 11¢ shy of the Wall Street forecast. Additionally, Tandem fell just short of expectations on sales, as analysts looked for $170.23 million in revenue.

Study backs Tandem Control-IQ artificial pancreas in young children

Image from Tandem Diabetes

Tandem Diabetes Care (Nasdaq:TNDM) announced positive study data for its artificial pancreas using Control-IQ technology.

The study demonstrated improved blood sugar control in children ages 2-6 with type 1 diabetes. It evaluated an artificial pancreas using the Tandem t:slim x2 insulin pump with Control-IQ technology. Results were published in the New England Journal of Medicine.

Tandem’s Control-IQ technology automatically monitors and regulates blood glucose. The artificial pancreas utilizes an insulin pump with advanced algorithms based on glucose monitoring from the Dexcom G6 CGM. Then it adjusts the insulin dose as needed. Control-IQ has FDA clearance for people ages six and older with type 1 diabetes.

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

Tandem Diabetes Care appoints new board chair

Tandem Diabetes Care (Nasdaq:TNDM) recently announced the appointment of Rebecca Robertson as the chair of its board of directors.

Robertson initially joined Tandem’s board as an independent director in January 2019. She succeeds Kim Blickenstaff as chair. Blickenstaff intends to continue as a member of the board.

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

Tandem Diabetes Care stock dips after hours on Q4 misses

Tandem Diabetes Care (Nasdaq:TNDM) shares fell after hours today on fourth-quarter results that came up shy of the consensus forecast.

Shares of TNDM dipped 5.4% to $37.90 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up 8.6%.

The San Diego-based automated insulin delivery technology maker posted losses of $15.85 million. That amounts to losses per share of 25¢ on sales of $220.5 million for the three months ended Dec. 31, 2022.

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

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 …

Tandem Diabetes Care completes acquisition of insulin pump maker AMF Medical

The Sigi insulin patch pump. [Image courtesy of Tandem Diabetes Care/AMF Medical]Tandem Diabetes Care (Nasdaq:TNDM) announced today that it completed its previously announced acquisition of AMF Medical.

San Diego-based Tandem announced plans to acquire the maker of the Sigi patch pump for insulin delivery last month. Switzerland-based AMF Medical does not offer Sigi commercially. The system received FDA breakthrough device designation just over one year ago.

The Sigi system, an ergonomic, rechargeable patch pump, features pre-filled insulin cartridges to reduce the burden of managing diabetes.

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

Tandem Diabetes Care expects double-digit revenue growth in 2023

Tandem Diabetes Care (Nasdaq:TNDM) announced preliminary fourth-quarter results and offered expectations for the coming year.

San Diego-based Tandem expects sales to total $221 million, coming in $11 million higher than the same quarter last year. Wall Street analysts expected $221.6 million in revenues. However, the automated insulin delivery technology developer noted that its adjusted sales rise to $224 million for the quarter. That total includes the impact of its Tandem Choice Program, which allows users to switch to a new pump model when available.

Shares of TNDM dropped more than 9% to $40.41 apiece by midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up more than 8%.

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