Abbott Archives - Page 3 of 34 - Medical Design Sourcing

FDA approves expanded MRI labeling for Abbott Proclaim neurostim

The Proclaim DRG neurostimulation device. [Image courtesy of Abbott]Abbott (NYSE: ABT) + announced today that the FDA approved expanded MRI labeling for its Proclaim DRG neurostimulation system.

Proclaim DRG provides targeted relief for people with complex regional pain syndrome (CRPS) types I and II of the lower limbs. It stimulates the dorsal root ganglion (DRG) clusters of nerve cells found along the spine.

Abbott says four out of five people who receive Proclaim DRG stimulation experience significant pain relief and improved quality of life.

The expanded labeling allows patients to receive full-body MRI scans while implanted with the device.

MRI can help assess the progression of CRPS. Having Proclaim DRG allow for MRI scans anywhere in the body (within approved parameters) provides value to patients and radiologists.

Expanded labeling allows for use of Abbott’s system in full-body scans for…

Abbott announces first procedures with Volt pulsed field ablation system

The Volt PFA system. [Image courtesy of Abbott]Abbott (NYSE: ABT) + today announced the first global procedures conducted with its new Volt pulsed field ablation system.

Volt treats patients battling common abnormal heart rhythms like AFib. It marks Abbott’s entry into the crowded pulsed field ablation (PFA) space alongside companies like Medtronic, Boston Scientific and Johnson & Johnson’s Biosense Webster.

Last month, Medtronic became the first company to win an FDA nod for PFA to treat paroxysmal and persistent AFib. Boston Scientific anticipates FDA approval for its Farapulse PFA system in the first quarter of this year.

Doctors treated more than 30 patients in Australia as part of the Abbott Volt CE mark study. The pre-market, multi-center trial aims to evaluate Volt’s safety and effectiveness. Abbott anticipates upcoming procedures in Asia Pacific and Europe. The company also expects FDA…

Diabetes unit continues to power growth at Abbott with Lingo coming to U.S. ‘soon’

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]With continued progress on established platforms, new acquisitions and new products, Abbott (NYSE: ABT) + has high expectations for its Diabetes business.

Speaking at the J.P. Morgan Healthcare Conference, CEO Robert Ford highlighted diabetes as a key area for near-term growth. Specifically, in the presentation transcribed by SeekingAlpha, Ford said he expects the FreeStyle Libre continuous glucose monitor (CGM) to significantly drive growth.

“FreeStyle Libre has fundamentally changed the management of diabetes,” Ford said. “[It’s] our market-leading wearable glucose sensor… There are now more than 5 million users of Libre around the world, with 2 million in the United States.”

Ford said the com…

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…

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

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…

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…

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…

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 …

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…

‘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,”…