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These diabetes devices are set to launch in 2024

The Stelo glucose monitor. [Image courtesy of Dexcom]The diabetes space continues to innovate and it doesn’t look like that’s stopping any time soon, with 2024 set to be another banner year.

At the end of 2023, we compiled a list of the 10 biggest diabetes technology stories of the year. Some of those stories didn’t end in 2023, though, as a few major product launches loom on the horizon.

New CGMs, insulin pumps and combinations of the two will all be coming to the market over the next several months. Here are some of the most highly-anticipated product launches set to take place in the diabetes space in 2024 — plus some of the tech that’s already launched:

Diabetes launches on the horizon Medtronic’s new pump-sensor combo

In January, Medtronic won CE mark for its MiniMed 780G automated insulin delivery system with the Simplera Sync sensor.

The MiniMed 780G with the Simplera Sync CGM and accompanying devices. [Image courtes…

How GLP-1s tanked and reshaped the medtech stock market in 2023

Analysts weigh in on how the GLP-1 craze caused one of the biggest swings in the medtech stock market in recent years.

[Image courtesy of Nick Chong on Unsplash]In a tumultuous year for the medtech industry, promising clinical trial results on glucagon-like peptide 1 agonists (GLP-1s) created a seismic shift in the medtech stock market, triggering one of the largest dips in market value that analysts have seen in years.

While analysts said the medtech stock market performed well in 2023 – driven by strong market growth from the backlog of procedures that built up during the pandemic and more innovation and new product launches from companies – the fear of GLP-1s prevailed among investors, sending medtech stocks down significantly in the second half of the year, even as top executives sought to allay concerns.

The specter of GLP-1s such as Novo Nordisk’s Wegovy and Ozempic loomed large, casting doubt on medtech’s future trajectory at the end of the year. However, the stocks have almost fully recovered since then. Analysts predict a rebound in 2024, with diminishing head…

Small patients, big design challenges: Pediatric device experts guide engineers on solutions

Abbott’s Amplatzer Piccolo — designed for catheter delivery inside an infant’s heart — is among the smallest pediatric devices ever made. [Image courtesy Abbott]

“What sets pediatric devices apart? It’s about giving children a chance at a full life,” said Dr. Lars Søndergaard, divisional VP of medical affairs and chief medical officer for Abbott’s Structural Heart division. “The solutions we design can’t just tackle the issue at hand — they need to enable normal development and stand the test of time across decades of life.”

Unlike the predictable anatomies of adults, young patients — some barely larger than the palm of a hand — are constantly changing, and those changes need to be accounted for in the long-term efficacy of the device. And though the challenges are substantial, the reward is immense. Successfully addressing an unmet need in pediatric care not only offer…

Abbott and Fujirebio work on neurological biomarker assay for researchers

Abbott announced that it entered into a partnership with Fujirebio to develop a research use only neurofilament-light chain (Nf-L) neurology biomarker assay.

The companies partnered to create this assay for use on Abbott’s Alinity i instruments. Abbott plans to make the assay available to researchers conducting studies demonstrating the utility of the Nf-L biomarker. Research with this biomarker is already ongoing in a variety of neurological diseases, according to a news release, including multiple sclerosis, Alzheimer’s, traumatic brain injury and cognitive impairment.

Abbott and Fujirebio plan to make this assay available for Alinity i by 2025. It’s the first research use only assay set to be brought to the Alinity i system. Abbott wants to explore the research use pathway for other new biomarkers to support the research community through Alinity i. It hopes to enable the faster development of diagnostics and therapeutics.

Fujirebio Presid…

FDA panel votes in favor of Abbott TriClip TEER system for treating tricuspid regurgitation

The TriClip transcatheter tricuspid valve repair system [Image courtesy of Abbott]Abbott (NYSE: ABT) + announced today that an FDA advisory committee ruled that the benefits of its TriClip outweigh the risks in treating tricuspid regurgitation (TR).

The Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA confirmed this with votes registering 13 to 1 in favor of TriClip’s benefits. Abbott submitted TriClip, a transcatheter edge-to-edge repair (TEER), to the FDA for premarket approval in March 2023. The company expects a decision on that submission from the FDA this year. The FDA will consider the panel’s vote when making its final decision.

If approved — which could prove more likely with the panel’s affirmative vote — it would take on the recently approved Edwards Evoque tricuspid valve, which became the first transcatheter therapy approved to treat TR earlier this mont…

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…