Abbott integrates FreeStyle Libre 2 Plus into Tandem’s automated insulin pump

t:slim X2 Insulin Pump from Tandem Diabetes Care with Abbott’s Freestyle Libre 2 Plus sensor integration now available in the United States. [Image courtesy of Abbott/Tandem Diabetes Care]Abbott (NYSE: ABT) + and Tandem Diabetes Care (Nasdaq:TNDM) today announced the integration of FreeStyle Libre 2 Plus CGM into the t:slim X2 insulin pump.

This marks the first automated insulin delivery system to integrate the newly available Abbott FreeStyle Libre 2 Plus sensor. The FDA cleared the updated Abbott continuous glucose monitor (CGM) for use with automated insulin delivery in March 2023. For the first time, users of the leading CGM sensor can utilize a hybrid closed-loop system to manage their diabetes.

Integration of these technologies comes shortly after Tandem became the first to integrate with the next-generation Dexcom G7 CGM. The t:slim X2 insulin pump with Control-IQ technology previously worked with the Dexcom G6. Read more

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FDA expects longer AED shortage, reports plans for Abbott HeartMate II discontinuation

The FDA now expects shortages of automated external defibrillators (AEDs) to persist longer than previously estimated, but removed four other product types from its list of medical device shortages.

The agency also added to its list of discontinued devices, including plans by Abbott to stop manufacturing its HeartMate II Left Ventricular Assist System (LVAS) in 2026.

AED shortage update

The FDA said shortages of wearable and non-wearable AEDs (product codes MVK and MKJ, respectively) will likely last through summer 2024. The federal agency updated its forecast last month after saying as recently as October that the shortage would last through 2023.

The FDA said the shortages are due to an increase in demand for the devices as well as a shortage or discontinuance of a component, part or accessory. Those devices have been on the shortage list since July 2022 as the agency required manufacturers to file for premarket approval (PMA) for previously cleared ac…

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The 10 biggest diabetes tech stories from 2023

Medtronic, EOFlow, Dexcom, Beta Bionics and Tandem Diabetes Care all contributed some of the biggest diabetes technology stories of 2023.

It was another banner year for diabetes technology, with regulatory approvals, product launches and M&A all playing their part.

Diabetes technology’s impressive 12 months marked a major trend across medtech as a whole, too.

In 2022, the diabetes space saw plenty of progress from some of its biggest names and this past year proved no different. Big hitters like Dexcom, Abbott, Medtronic, Insulet and more all contributed to some of the biggest stories in 2023. External factors — like popular GLP-1 drugs and big tech names looking to enter the space — also made the cut.

Here are 10 of the most intriguing diabetes technology stories from the past 12 months.

Medtronic was set to buy EOFlow — until it wasn’t

The medtech giant made a big splash in the insulin delivery space when it announced its plan to buy South K…

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The top medtech trends of 2023

The top medtech trends of 2023 included innovations such as artificial intelligence, new GLP-1 weight loss drugs and some long-awaited medtech finally receiving regulatory nods.

With health providers facing additional challenges on top of an ever-uncertain economic environment, medtech companies also made major readjustments: layoffs, spinoffs, reorganizations and much more.

Here are the top stories that caught the attention of MassDevice readers and editors in 2023.

Top 2023 medtech trend No. 10: Questions about GLP-1 drugs

U.S. health providers wrote more than 9 million prescriptions in just three months for Wegovy, Ozempic and similar glucagon-like peptide-1 (GLP-1) weight loss drugs, according to analytics firm Trilliant Health. The popularity and initial effectiveness of the new drugs had medtech industry analysts asking a lot of questions about how the potential health benefits could reduce demand for devices. Medical device executives, however, we…

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Medtronic weighs in on GLP-1 impact for device manufacturers

Medtronic CEO and Chair Geoff Martha [Photo courtesy of Medtronic]

Medtronic is the latest — and largest — device manufacturer to weigh in on GLP-1 weight loss drugs and how they could affect demand for medical devices.

Medtronic Chair and CEO Geoff Martha today said the world’s largest medical device company doesn’t expect GLP-1 (glucagon-like peptide-1) drugs like Ozempic and Wegovy to take a big bite out of its business.

While Medtronic said the drugs have had a “modest impact” on the bariatric surgery market, Medtronic thinks that is only temporary. The rate of decline in Medtronic’s bariatric business has already stabilized, Martha said on the company’s second-quarter earnings call, adding, “I think we see that coming back in the coming year.”

“We feel strongly that we don’t see these drugs impacting Medtronic’s growth, medium …

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November 2023 Medical Device Handbook: Breaking new ground in medtech



 

How Abbott designed the world’s first dual-chamber leadless pacemaker system

J&J used RWE for expanded indications — and you can, too

Moon Surgical thinks Maestro’s light touch can win the surgical robotics arms race

Breaking new ground in medtech

This year has brought a flurry of firsts from medical device manufacturers as they develop new and improved products despite continued supply chain and economic challenges.

These device innovations have been in the works for years, pushed forward by teams ranging from small startups to the world’s largest medtech companies — and all with help from outsourcing partners.

All of these industry players have come together once again in our latest edition of the Medical Design & Outsourcing Medical Device Handbook to offer uniquely relevant and actionable advice for device designers and engineers.

This edit…

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‘A safe pair of hands’ — Medtech’s investment in Ireland continues to grow

Killilagh, Ireland. [Image by Sean Whooley]Medtech established its presence in Ireland many years ago and still, companies continue to invest in the ever-growing country.

Boston Scientific established operations in Ireland in 1994, while Abbott has more than 70 years in the country. Medtronic, now officially headquartered in Dublin, has spent more than 40 years in Ireland and even hosted its 2023 annual meeting in the country.

Those companies, plus many more, continue to invest in Ireland, while more big names in medtech are coming to the table. Dexcom, for instance, earlier this year chose Athenry as its first European manufacturing location with a more than $325 million investment.

Speaking to MassDevice, Dexcom EVP of Global Operations, Barry Regan, explained what attracted the company to the growing medtech hub.

“One way I would describe Ireland when it comes to medtech operations and manufacturing is it’s a safe pair of hands,”…

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Here’s what diabetes tech companies are doing on World Diabetes Day

Every November, the diabetes community comes together to recognize both National Diabetes Month in the U.S. and World Diabetes Day.

World Diabetes Day falls on today, Nov. 14, to mark the birthday of Sir Frederick Banting. Banting discovered the insulin hormone along with Charles Herbert Best in 1922.

In an effort to drive awareness and understanding of the chronic condition, a number of medtech companies in the diabetes space undertake efforts each year to celebrate and draw attention to the day and month recognizing the community. We compiled lists in 2021 and 2022 to share some of the initiatives brought forward by these companies.

On World Diabetes Day in 2023, here is what medtech’s diabetes community is doing:

Abbott

Abbott (NYSE:ABT) launched its new “Countdown at a Crossroads” initiative to mark National Diabetes Awareness Month.

The initiative features an animated installation promoting diabetes awareness at the Oculus Center…

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Abbott launches dual-chamber pacemaker with first U.S. implants

The Aveir dual-chamber leadless pacemaker [Image courtesy of Abbott]The first U.S. commercial cases have been completed with the Abbott (NYSE: ABT) + Aveir dual-chamber leadless pacemaker technology.

Abbott announced in July that it received FDA approval for the Aveir system. The approval marked the first such nod for a dual-chamber leadless pacing system for treating abnormal or slow heart rhythms.

According to Abbott, more than 80% of people who need a pacemaker require pacing in two chambers of the heart — the right atrium and right ventricle.

The system was included in Time magazine’s recent list of 2023’s best inventions. Matthew Fishler, the lead engineer on the Abbott Aveir project, explained how the company developed the system earlier this year.

Now, the commercially available system has been implanted in patients in the U.S. Dr. Rajesh Banker performed one implant at Hoag Memorial Hospi…

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Why Stryker says GLP-1 weight loss drugs could boost joint replacements

Stryker says weight loss drugs could help obese patients slim down for knee and hip replacements. (Pictured is Stryker’s Triathlon Cementless knee.) [Image courtesy of Stryker]

Executives at Stryker, the world’s largest orthopedic device manufacturer, say they’re not afraid that GLP-1 weight loss drugs could hurt demand for joint replacement implants.

Instead, they see GLP-1 drugs — including Ozempic and Wegovy — as a neutral factor or perhaps even a slight positive. That’s because the drugs could help obese and near-obese patients slim down to qualify for knee and hip replacement surgery.

“We don’t anticipate the weight loss drug having a negative impact,” Lisa Kloes, the GM and VP of Stryker’s knee business, said in an interview with Medical Design & Outsourcing. “Actually, we think it’s going to help with implant volumes. There’s qu…

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These 11 medical device inventions are the best of 2023, Time magazine says

Time’s best medical device inventions of 2023 include: (clockwise from top left) ViviStim, Coros, Cala kIQ, InVision. [Images courtesy of the companies]

Time magazine recently named 11 medical device inventions among its best inventions of 2023.

The devices highlighted in the ranking ranged from wearables to treat tremor to leadless pacemakers.

Time magazine says it has identified the most impactful ideas, devices and technologies around the world for more than 20 years. The publication says it compiled the list through nominations from its editors and global correspondents, with special attention to certain categories like medical innovations, accessibility, AR/VR, sustainability, wellness and more.

Time then graded each nominee based on a number of key factors that included originality, efficacy, ambition and impact.

This year’s list included 11 devices from startups and major…

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Abbott rolls out National Diabetes Awareness Month initiative to promote CGM use

The Countdown at a Crossroads initiative kicks off this month. [Image courtesy of Abbott]Abbott (NYSE:ABT) announced today that it launched its new “Countdown at a Crossroads” initiative for National Diabetes Awareness Month.

The initiative sees Abbott take over the Oculus Center in New York City with an animated installation promoting diabetes awareness. This installation features the faces and stories of people impacted by diabetes, including comedian and talk show host Sherri Shepherd.

Shepherd, a diabetes advocate, uses Abbott’s FreeStyle Libre continuous glucose monitor (CGM) to manage her condition.

“Using a FreeStyle Libre sensor to monitor my glucose levels has helped me get a better grasp on my Type 2 diabetes and ultimately improve my quality of living,” said Shepherd. “Many people living with diabetes aren’t aware of this incredible life-changing technology and Abbott’s efforts to make it accessible…

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