Abbott Archives - Page 5 of 34 - Medical Design Sourcing

Analysts: GLP-1 drugs should have minor impact on insulin pump market — but will boost CGMs

From left: the Insulet Omnipod 5, Medtronic MiniMed 780G and the Senseonics Eversense E3. These technologies could be among those affected by the rise of the GLP-1 drug class. [Images courtesy of Insulet, Medtronic and Senseonics]Based on conversations with diabetes experts, analysts are playing down the potentially negative impact of GLP-1 receptor agonists on the diabetes technology industry.

The GLP-1 drug class, which includes Ozempic and Wegovy, has cast a shadow of doubt over diabetes technology of late. This therapeutic class, a glucagon-like peptide 1, has proven to lead to improved blood sugar control and weight loss.

In addition to the popular therapeutics, some companies — like i20 Therapeutics and Vivani Medical — are developing long-term implants that elute GLP-1s.

Positive clinical results from these drugs led to some negative market movement for a few of the biggest names in diabetes technology. Analysts even recently trimmed some forecasts o…

Abbott to acquire insulin management company Bigfoot Biomedical

The Bigfoot Unity platform, now acquired by Abbott. [Image courtesy of Bigfoot Biomedical]Abbott (NYSE:ABT) announced today that it entered into a definitive agreement to acquire smart insulin management company Bigfoot Biomedical.

The transaction remains subject to customary closing conditions and the companies declined to disclose financial terms. They expect it to close in the third quarter of 2023.

Abbott has a longstanding relationship with Bigfoot going back to 2017. The medtech giant even led a financing round for the company back in 2020.

Bigfoot develops the Bigfoot Unity smart insulin management system. The FDA-cleared Bigfoot Unity platform aims to simplify continuous glucose monitors (CGMs) and the data they produce. It features a smart insulin pen cap, which takes data from a CGM and informs the patient exactly how much insulin they need.

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

What are the largest medical device companies?

Medtronic, Johnson & Johnson MedTech and Siemens Healthineers again lead the Medtech Big 100 list of largest medical device companies.

However, there is so much more to Medical Design & Outsourcing and MassDevice‘s 2023 edition of the Medtech Big 100 report. We pulled thousands of data points to provide information on annual revenue, R&D spending, headcount, CEOs and key leaders, headquarters locations and descriptions of each of the 100 largest medical device companies.

Senior Editor Danielle Kirsh’s analysis shows that even as the largest medtech companies engaged in layoffs over the past year, they also made a bet on innovation to boost future growth: R&D spending increased nearly 13% to $26.4 billion. (Read the full story on MDO.)

In addition, the full Medtech Big 100 list includes already completed medtech company spinoffs such as Embecta , GE HealthCare and ZimVie.

Read the full Medtech Big 100 report to find out …

Abbott study shows OCT intravascular imaging improves stent procedure outcomes

The Ultreon 1.0 OCT platform. [Image courtesy of Abbott]Abbott (NYSE: ABT) + announced late-breaking data supporting the use of optical coherence tomography (OCT) imaging.

The ILUMIEN IV OPTIMAL PCI study evaluated the use of OCT during percutaneous coronary interventions (PCI). OCT imaging offers additional high-definition images that improve the visualization of vessel structure. This provides doctors with actionable data that translate into patient benefits, potentially shifting future approaches.

Abbott’s Ultreon OCT software, powered by AI, guides stents for precision placement. It provides enhanced views of coronary anatomy and blockages, supporting physician decision-making in real-time.

Compared to angiography, the study showed that this method helps improve stent expansion for a greater minimal stent area (MSA). Abbott says OCT guidance during PCI is associated with a lower risk of stent thrombosis (…

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

Abbot’s Aveir DR (left) and VR (right) leadless pacemakers communicate wirelessly with each other from different chambers of the heart. [Image courtesy of Abbott]

The lead engineer on Abbott’s Aveir project explains how his team developed a first-of-its-kind wireless pacemaker system that communicates through blood.

When Abbott’s Aveir DR pacemaker system became the first approved by the FDA for dual-chamber pacing this year, it expanded the benefits of leadless pacing to the majority of patients who need stimulation of both the atrium and ventricle chambers.

The lead engineer on the Aveir project, Matthew Fishler, was working on leadless pacemaker technology at Nanostim when it was acquired by St. Jude Medical in 2013. (Abbott then purchased St. Jude in 2017.) He traced the idea for a dual-chamber leadless system in an effort to eliminate lead failures and other complications of tradition…

Find solutions to your most demanding medtech problem at DeviceTalks West

Add some essentials to your toolbox with engineering expertise from our upcoming show in California.

Intuitive President Dave Rosa will give a keynote interview at DeviceTalks West 2023. [Photo courtesy of Intuitive]

In the medical device industry, stubborn problems can cost millions in development expenses and delay the introduction of new life-saving tools and technologies.

That’s why we build our DeviceTalks meetings as a forum where successful medical device engineers, manufacturers and market-builders can share their best practices, providing solutions that help clear hurdles, speed product development and potentially save lives.

DeviceTalks attendees leave our meeting with notebooks full of critical advice and pockets full of business cards. We’ll help fill both at DeviceTalks West, which takes place Oct. 18-19 at the Santa Clara Convention Center in California. You can view the full agenda on our…

FDA clears Abbott Alinity h-series hematology system

The Alinity h-series hematology system. [Image courtesy of Abbott]Abbott (NYSE: ABT) + announced today that the FDA cleared its advanced Alinity h-series hematology system.

FDA clearance enables laboratories to run complete blood counts (CBCs) as part of Abbott’s Alinity family of diagnostic products. CBCs, among the most ordered tests in healthcare, help to screen for a variety of disorders. That includes infections, anemia, diseases of the immune system and blood cancers.

The Alinity h-series includes Alinity hq, an automated hematology analyzer, and Alinity hs, an integrated slide maker and stainer. Abbott said Alinity hq’s key differentiator is the leveraging of advanced MAPSS technology. MAPSS uses light scattering to distinguish cellular features and better identify various blood cells.

Abbott says that bringing the Alinity h-series to market enables it to offer one of the broadest laboratory diag…

Abbott FreeStyle Libre 3 reader is now available, covered by Medicare

The FreeStyle Libre 3 reader with the sensor and smartphone. [Image courtesy of Abbott]Abbott (NYSE: ABT) + has made its FreeStyle Libre 3 reader available in the U.S., enabling people on Medicare to access the system.

The FreeStyle Libre 3 reader pairs with the company’s latest continuous glucose monitor (CGM) sensor, cleared by the FDA last year. The addressable market for the sensor keeps growing, with massive coverage expansions all around the globe.

A Medicare coverage update kicked in this past spring, expanding access to the sensor. This modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.

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

Abbott is pulling its Trifecta valves off the market

The Trifecta GT heart valve [Image courtesy of Abbott]Abbott (NYSE: ABT) + announced today that it is withdrawing its Trifecta family of heart valves from worldwide markets.

The market withdrawal comes more than five months after Abbott and the FDA told health providers that the valves could deteriorate early.

In a statement shared with MassDevice, the company said: “Abbott has decided to withdraw and discontinue its Trifecta family of valves to focus on its next-generation tissue valves that maximize possibilities for lifetime management of valvular heart disease.”

In a letter dated today and shared by the FDA, the company told U.S. health providers that it would collect its unused consigned inventory and assist in the returns of any customer-owned inventory.

The company added in its shared statement: “Abbott is initiating inventory-related activities worldwide for unused Trifecta and Trif…

Abbott has a serious recall involving its Amplatzer delivery sheath

The Amplatzer steerable delivery sheath [Image courtesy of Abbott]The FDA today said an Abbott recall involving its Amplatzer steerable delivery sheath is Class I, its most serious level.

Launched in the U.S. in April 2022, the Amplatzer sheath delivers Abbott’s Amplatzer Amulet left atrial appendage occluder. Competing against Boston Scientific’s Watchman, Amplatzer Amulet provides complete occlusion in order to reduce the risk of ischemic stroke among people with atrial fibrillation.

Abbott, in June, initiated a recall of model No. ASDS-14F-075 of the sheath — 672 devices distributed in the U.S. between Oct. 4, 2022, and Feb. 22, 2023 — because there is an increased risk for the introduction of air bubbles (air emboli) into patients who have procedures with this device, according to the FDA.

The company reports 26 incidents, 16 injuries, and no deaths related to this issue.

Abbott is asking health providers to return any remaining unuse…

Abbott Diabetes business booms in Q2, company set to submit new sensor in U.S. this year

The FreeStyle Libre 3 continuous glucose monitor. [Image courtesy of Abbott]Abbott (NYSE:ABT) today shared a number of positive updates on its Diabetes business as part of its second-quarter earnings report.

The medtech giant’s Diabetes unit brought in sales of $1.4 billion in the quarter, marking 19.4% growth year-over-year.

Its FreeStyle Libre continuous glucose monitors (CGMs) continue to drive growth as CEO Robert Ford projected earlier this year. The addressable market for the sensor keeps growing, with massive coverage expansions all around the globe. Medicare’s coverage update kicked in this past spring. This modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.

Last month, France authorized reimbursement to include all people who use basal insulin as part of their diabetes management.

“This achievement was a direct result of the unique value proposition that L…

Abbott beats The Street in Q2 — ups sales growth forecast

Abbott (NYSE: ABT) + today announced second-quarter results that beat the consensus of Wall Street analysts — boosting its full-year organic sales growth forecast.

The company has now seen two quarters in a row of double-digit organic sales growth in its underlying business. Even as COVID-19 test sales continue to decline and hammer overall revenue, Abbott officials are betting on a productive, innovative pipeline to build momentum — especially in its Medical Device business. CEO Robert Ford said underlying demand trends continue to improve. “Healthcare systems around the world have improved the supply of healthcare services,” Ford told analysts today.

Ford concluded: “Momentum is building. We’re well-positioned heading into the second half of this year and heading into next year.”

Investors reacted by sending ABT shares up more than 4% to $112.17 apiece in morning trading. MassDevi…