Abbott Archives - Page 2 of 34 - Medical Design Sourcing

Insulet integrates Abbott FreeStyle Libre 2 Plus, Omnipod 5 in Europe

The Omnipod 5 with the Abbott FreeStyle Libre 2 Plus. [Image courtesy of Insulet]Insulet (Nasdaq: PODD) + announced today that it received CE mark approval for the integration of the Abbott (NYSE: ABT) + FreeStyle Libre 2 Plus with Omnipod 5.

European approval covers the compatibility of Abbott’s glucose sensor with the Insulet automated insulin delivery system for individuals aged two years and older with type 1 diabetes.

Currently, Omnipod 5 works with Dexcom CGM. Right now, it has compatibility with the previous-generation G6 as the companies work on integrating the G7. However, Insulet hinted at the future integration with Abbott’s popular FreeStyle Libre system midway through last year.

This also marks the second major insulin pump integration for Abbott in 2024. Last month, the company announced FreeStyle Libre 2 Plus compatibility with the Tandem Diabete…

Abbott enters into new $5B credit facility

Abbott (NYSE: ABT) + announced that it entered into a five-year credit agreement worth up to $5 billion on an unsecured basis.

The company entered into the agreement with lenders from time to time party thereto and JPMorgan Chase Bank as administrative agent.

According to an SEC filing, the agreement gives Abbott the ability to borrow up to $5 billion on an unsecured basis. Any borrowings will mature and be payable on the fifth anniversary of the effective date. As of the date of the filing, the company has no outstanding borrowings under the revolving credit agreement.

Borrowings under this agreement bear interest, at Abbott’s option, based on either a base rate or SOFR rate. The agreement also includes an applicable margin based on Abbott’s credit ratings in effect from time to time. Abbott also intends to pay to lenders certain customary fees.

In connection with the new agreement, Abbott te…

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…

Abbott wins FDA nod for world’s smallest rechargeable DBS system

The Liberta RC DBS device. [Image from Abbott]Abbott (NYSE: ABT) + announced today that it received approval from the FDA for the launch of its Liberta RC DBS system.

Liberta RC DBS (rechargeable deep brain stimulation) features remote programming for treating people with movement disorders. Abbott says it requires the fewest recharges of any FDA-approved DBS system, needing just 10 recharge sessions a year for most users.

The system is also the first and only rechargeable DBS device compatible with Abbott’s proprietary NeuroSphere virtual clinic. NeuroSphere allows people to communicate with doctors, ensure proper settings and functionality and receive new treatment settings remotely.

This regulatory nod also comes just weeks after Medtronic won FDA approval for what it considers a “game-changing” DBS system. Abbott continues to progress with its own neurostimulation business as well. It won expa…

Abbott reports double-digit growth across Medical Devices in Q4 as Diabetes, EP lead the way

Abbott (NYSE: ABT) + today reported fourth-quarter earnings that included double-digit revenue growth across its entire Medical Devices unit.

Shares of ABT fell 2.6% to $111 apiece before the market opened today. The share price slightly improved to $111.50 shortly after the market opened. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose slightly.

The Abbott Park, Illinois-based medtech giant posted profits of $1.6 billion. That equals 91¢ per share on sales of $10.24 billion for the three months ended Dec. 31, 2023. Abbott recorded a 54.3% bottom-line gain on sales growth of 1.5%.

Adjusted to exclude one-time items, earnings per share totaled $1.19, equalling expectations on Wall Street. Sales posted a narrow beat as analysts projected $10.18 billion in revenue.

The company’s most significant growth came in the Medical Devices…

How does medtech CEO compensation compare?

[Image from Unsplash]Medtech CEO compensation averaged $10.5 million during the companies’ most recent fiscal years.

That number from our recent MassDevice analysis may seem like a lot to an average person — but not as much in the world of corporate CEOs.

In fact, the average compensation of S&P 500 company CEOs was $25.2 million in 2022, according to the Economic Policy Institute (EPI), a nonprofit research institute that studies the impact of economic trends and policies on working people in the U.S.

Geoff Martha, who, as CEO of Medtronic, runs the world’s largest medical device company, saw a total compensation of $15.4 million. But look over at the pharmaceutical industry, where revenue numbers are much higher, and the head of the world’s largest pharma company — Pfizer CEO Albert Bourla — brought in $33 million.

As businesses mature into publicly traded companies and revenue grows, it makes sense for CEO compensation to become larger.

Abbott bets on balloons in pulse field ablation battle

The Abbott Volt aims to beat first-generation pulse field ablation (PFA) systems with its balloon-in-basket design and other features.

The Abbott Volt pulse field ablation (PFA) catheter features a balloon-in-basket design and eight electrode splines. [Image courtesy of Abbott]

One component stands out as unique when you compare the Abbott Volt against competing pulse field ablation (PFA) systems from Medtronic and Boston Scientific.

The Volt cardiac ablation catheter has a balloon, something you won’t see on Medtronic’s PulseSelect PFA catheter — the first of its kind approved by the FDA — or the Farawave catheter in the Farapulse PFA system that Boston Scientific expects will soon win approval.

The Abbott Volt’s balloon-in-basket is designed to support the efficient deployment of energy into the tissue during cardiac ablation to treat atrial fibrillation (AFib). That energy creates le…

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…