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Abbott Highlights Lower Mortality and Hospitalization Risk With Libre CGM in Type 2 Diabetes

Abbott reported new real-world data linking continuous glucose monitoring, including its Libre technology, with lower mortality and fewer cardiovascular complications among adults with Type 2 diabetes using basal insulin.

In a U.S. study of nearly 28,000 adults, CGM use was associated with a 45% lower risk of death at 12 months and a 36% lower risk at 24 months compared with non-users. Researchers also found fewer cardiovascular-related complications among CGM users.

A separate French observational study involving more than 253,000 people with Type 2 diabetes found that acute diabetes-event hospitalizations fell 47% among basal-insulin users after starting Libre. The reduction was 56% among people using multiple daily insulin injections and 81% among those using non-insulin therapies.

Abbott is also highlighting new FreeDM2 trial analyses showing that people using Libre 3 experienced improvements in time in range within the first 24 hours, with benefits sustained over time.

The company is also showcasing Libre Assist, an AI-powered feature that predicts how food choices may affect glucose levels and provides personalized meal guidance.

The findings strengthen Abbott’s case for broader CGM use beyond intensive insulin therapy, although the mortality results are observational and show association rather than proof of causation.

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European Investor 09-28-26

Abbott and Berry Street Partner to Expand Personalized Nutrition Support Using Lingo CGM

Abbott and Berry Street announced an exclusive partnership that combines Abbott’s Lingo continuous glucose monitor with virtual support from registered dietitians to help consumers make more personalized nutrition and lifestyle decisions.

Lingo is an over-the-counter CGM designed for adults who are not using insulin. It shows how factors such as food, exercise, sleep and stress affect glucose levels, while Berry Street dietitians will use that data to provide individualized nutrition guidance.

Through the partnership, users can access dietitians trained on Lingo and continuous glucose monitoring, receive recommendations based on their glucose patterns and meet virtually through one-on-one appointments. Berry Street is in-network with more than 1,250 health plans, and the company said 96% of clients pay no out-of-pocket cost, depending on their insurance coverage.

Berry Street users will also be able to purchase Lingo at a 15% discount on four-week plans, while dietitians can view patients’ glucose data to provide more targeted coaching.

The partnership expands Abbott’s push into consumer metabolic health by combining real-time biosensor data with human nutrition expertise, rather than positioning glucose tracking as a standalone wellness tool.

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The Investor 09-23-26

Abbott Expands Volt Pulsed Field Ablation System to Canada

Abbott (NYSE: ABT) announced the first commercial use of its Volt Pulsed Field Ablation System in Canada, marking an expansion of the company’s next-generation technology for treating atrial fibrillation. The first Canadian procedures were performed at McGill University Health Centre in Montreal.

Volt uses high-energy electrical pulses to target heart tissue responsible for abnormal rhythms. Its balloon-in-basket catheter is designed to improve tissue contact and deliver precise energy with fewer therapy applications, while integration with Abbott’s EnSite X platform provides 3D cardiac mapping and reduces catheter exchanges.

The system can also support conscious sedation instead of general anesthesia and is designed to reduce radiation exposure during procedures, potentially improving procedural efficiency and recovery.

Health Canada authorized Volt in April 2026 following clinical evidence including Abbott’s 392-patient VOLT-AF IDE study. The system is also approved and available in the U.S., Europe and Australia, expanding Abbott’s position in the growing cardiac electrophysiology and pulsed-field ablation market.

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The Investor 09-15-26

Abbott Reaches $385 Million Settlement With DOJ Over 2022 Infant Formula Recall

Abbott said it reached an agreement to resolve U.S. Department of Justice and related state claims stemming from the company’s manufacturing operations and 2022 recall of powdered infant formula from its Sturgis, Michigan facility.

Under the agreement, Abbott will pay a total of $385 million to resolve the claims. The company emphasized that the settlement does not constitute a finding of fault or liability and said the government had previously closed its criminal investigation into the matter.

Abbott also said no unopened, distributed infant formula involved in the matter ever tested positive for Cronobacter sakazakii. According to the company, FDA testing of unopened products from the homes of infants investigated during the recall was negative, while the CDC later concluded there was no definitive link between the Sturgis facility and the clinical cases under investigation.

The settlement provides greater legal clarity around a major issue that has followed Abbott since the 2022 recall, which disrupted U.S. infant-formula supplies and drew significant regulatory scrutiny. The $385 million payment represents a financial cost for Abbott, but resolving the litigation removes an important source of uncertainty surrounding its nutrition business.

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WS Investor 09-14-26

Abbott Wins FDA Approval for TactiFlex Duo Ablation Catheter to Treat Atrial Fibrillation

Abbott (NYSE: ABT) received U.S. Food and Drug Administration approval for its TactiFlex Duo Ablation Catheter, expanding the company’s portfolio of cardiac ablation technologies for treating atrial fibrillation.

TactiFlex Duo combines pulsed field ablation (PFA) and radiofrequency (RF) energy in a single catheter, allowing physicians to use either energy source or a combination of both when treating complex AFib cases. Abbott said the flexibility can help physicians tailor procedures to individual patients while minimizing the impact on surrounding healthy tissue.

The catheter also integrates with Abbott’s EnSite X EP System, which provides real-time three-dimensional mapping and feedback during procedures.

FDA approval was supported by results from Abbott’s FlexPulse IDE study. Data recently presented at the European Society of Cardiology Congress 2026 showed favorable safety and effectiveness outcomes in patients with paroxysmal AFib.

The approval strengthens Abbott’s position in the rapidly developing PFA market and follows other recent cardiac ablation approvals across the U.S., Europe, Asia and Latin America.

Abbott plans to begin initial U.S. procedures soon, followed by broader commercial adoption in the coming weeks. The launch adds another treatment option to Abbott’s electrophysiology portfolio as the company expands its presence in technologies used to diagnose, map and treat abnormal heart rhythms.

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The Investor 09-08-26

Abbott Reports Positive Phase 3-Style Clinical Data for TactiFlex Duo AFib Catheter

Abbott (NYSE: ABT) announced positive 12-month clinical results for its investigational TactiFlex Duo Ablation Catheter, a device designed to treat challenging cases of atrial fibrillation (AFib).

TactiFlex Duo combines pulsed field ablation (PFA) and radiofrequency (RF) energy in a single catheter, allowing physicians to select or combine ablation approaches depending on a patient’s needs. The technology works with Abbott’s EnSite X cardiac mapping system to provide real-time feedback during procedures.

In the FlexPulse Global IDE study, 92.6% of patients with paroxysmal AFib had no documented recurrence of AFib, atrial flutter or atrial tachycardia under standard-of-care monitoring. Under more rigorous protocol-driven monitoring, 77.4% remained free from documented recurrence.

The study also met its primary effectiveness endpoint, with 74.6% of patients remaining free from documented arrhythmias, medication changes or repeat procedures. Abbott reported a 98.3% safety rate with no major safety events.

The results are important for Abbott’s electrophysiology business as competition intensifies in the fast-growing PFA market. Combining PFA and traditional RF energy in one catheter could differentiate TactiFlex Duo by giving physicians greater flexibility when treating more complex arrhythmias.

The device received CE Mark in Europe earlier this year, while the FlexPulse IDE study is intended to support an application for U.S. FDA approval. The latest data were presented at the European Society of Cardiology Congress 2026 and published in EP Europace.

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The Investor 08-31-26

Abbott Wins CE Mark for Next-Generation Amulet 360 Stroke Prevention Device

Abbott (NYSE: ABT) has received CE Mark approval for its next-generation Amulet 360 Left Atrial Appendage Occluder, allowing the company to begin expanding the device across Europe.

Amulet 360 is designed for patients with non-valvular atrial fibrillation who are at risk of stroke, particularly those unable to remain on long-term blood-thinning medication. The minimally invasive device seals the left atrial appendage, where blood clots commonly form in AFib patients.

The approval was supported by the 400-patient VERITAS study. Amulet 360 was successfully implanted in 99.8% of patients, while 93.9% achieved complete closure after 45 days with no leaks larger than 3 mm. No strokes, blood clots or additional surgeries were reported during the first seven days.

The approval strengthens Abbott's cardiovascular device portfolio and marks its fourth major electrophysiology approval in just over a year. Initial European procedures have already been completed in Germany and Denmark, with a broader European rollout planned in the coming weeks.

Amulet 360 remains investigational and is not yet approved for commercial use in the U.S.

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Global Finance News 08-27-26

Abbott Wins FDA Authorization for World’s First Dual Glucose-Ketone Sensor

Abbott Laboratories (NYSE: ABT) has received U.S. Food and Drug Administration authorization for Libre Duo 10 Day, which the company says is the world’s first wearable system capable of continuously monitoring both glucose and ketone levels.

The authorization represents an important expansion of Abbott’s diabetes-care technology beyond conventional continuous glucose monitoring. The company plans to launch Libre Duo 10 Day in the United States later in 2026.

Libre Duo Targets a Critical Diabetes Risk

Libre Duo continuously tracks glucose while monitoring ketone levels in the background. Rising ketones can signal the development of diabetic ketoacidosis, or DKA, a potentially life-threatening complication that can progress rapidly when the body does not have enough insulin.

Traditional blood or urine ketone tests provide a single reading and generally require users to recognize when testing is necessary. Abbott’s system instead continuously monitors ketones and is designed to alert users when levels are rising.

The device received FDA De Novo authorization after previously receiving Breakthrough Device designation. According to Abbott, Libre Duo is the first system to meet both the FDA’s integrated continuous glucose monitoring standard and its new integrated continuous glucose and ketone monitoring standard.

The technology is intended for people with diabetes aged two years and older and offers up to 10 days of wear.

Integration With Insulin Delivery Systems Expands Opportunity

A potentially important commercial component is Abbott’s plan to integrate Libre Duo with automated insulin delivery systems.

Abbott expects compatibility with Beta Bionics’ iLet and Sequel Med Tech’s twiist systems by the end of 2026, followed by integrations with Insulet and Tandem devices in 2027. Abbott is also collaborating with MiniMed on an exclusive integration between Abbott-manufactured dual glucose-ketone sensors and MiniMed smart-dosing systems, expected in 2027.

Libre Duo will also connect with Abbott’s broader Libre ecosystem, including LibreView for healthcare providers and LibreLinkUp for caregivers.

Why the FDA Authorization Matters for Abbott

The approval strengthens Abbott’s competitive position in the rapidly developing continuous glucose monitoring market by introducing a capability beyond glucose measurement alone.

Rather than competing only on CGM accuracy, sensor size, wear duration and software features, Abbott is adding continuous ketone monitoring as a new layer of clinical functionality. The technology could be particularly relevant for insulin users and people taking SGLT2 medications who may face increased risk from elevated ketones.

The authorization also expands Abbott’s opportunity to make its Libre platform more deeply integrated into automated diabetes-management systems. If dual glucose-ketone sensing becomes incorporated into insulin pumps and smart-dosing platforms, Libre Duo could strengthen Abbott’s position within the broader diabetes-device ecosystem rather than functioning solely as a standalone sensor.

Abbott had already secured CE Mark approval for Libre Duo systems earlier in 2026. The FDA authorization now clears the way for the technology to enter the important U.S. market later this year.

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The Investor 08-26-26

Abbott Partners With Google to Bring AI-Powered Glucose Insights to Everyday Health

Abbott (NYSE: ABT) announced a multi-year partnership with Google Health aimed at combining continuous glucose monitoring with artificial intelligence to provide more personalized health insights.

Under the partnership, glucose data from Abbott’s Lingo biowearable will be integrated into the Google Health app alongside other health and wellness information. Google Health Coach will use the data to generate personalized recommendations related to nutrition, physical activity, sleep and recovery.

The companies also plan to conduct what they describe as one of the largest real-world metabolic health studies, combining continuous glucose, wearable, laboratory and survey data. Findings are expected to help improve future AI coaching and Lingo features.

For Abbott, the agreement could broaden the role of its continuous glucose monitoring technology beyond traditional diabetes management. Lingo is an over-the-counter CGM designed for adults who do not use insulin, allowing users to track how factors such as food, exercise, sleep and stress affect glucose levels.

The collaboration also strengthens Abbott’s exposure to the growing intersection of wearable health technology and AI. Lingo integrations within Google Health are expected to begin rolling out later in 2026.

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The Investor 08-11-26

Abbott Laboratories announced it has received U.S. FDA clearance and CE Mark approval for its next-generation Ultreon 3.0 AI-powered coronary imaging platform.

The system combines optical coherence tomography (OCT) imaging with AI-driven insights to help physicians better assess arterial blockages and optimize stent placement during minimally invasive heart procedures. The platform enables real-time decision-making, improved accuracy, and faster workflows, aiming to enhance patient outcomes in complex coronary artery disease cases.

Abbott highlighted that the technology provides high-resolution imaging and automated analysis, supporting more precise and efficient treatment planning for procedures such as percutaneous coronary intervention (PCI).

Source: Abbott press release, PRNewswire

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The Investor 04-28-26

01-22-26WS News

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