Abbott Laboratories NYSE:ABT Price, Chart, News & Insight

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

Abbott presented new clinical data highlighting strong outcomes for its technologies targeting heart rhythm disorders at the Heart Rhythm Society 2026 conference. The results covered multiple trials across its pulsed field ablation (PFA) and conduction system pacing (CSP) portfolios, including treatments for atrial fibrillation.

Six-month data from the FlexPulse study showed high success rates, with 87% of patients free from arrhythmias and a strong safety profile, while additional studies demonstrated promising results for Abbott’s investigational pacing and defibrillation devices.

The company said the findings reinforce the effectiveness and safety of its technologies and support ongoing innovation in treating complex cardiac conditions through more advanced and personalized therapies.
PRNewswire

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The Investor 04-26-26

Abbott announced new clinical data demonstrating progress in its Cancerguard multi-cancer early detection (MCED) test at the 2026 American Association for Cancer Research (AACR) Annual Meeting, highlighting improved early-stage cancer detection using a multi-biomarker approach.

The data show that combining methylation and protein biomarkers enhances detection across cancer types and stages, with each biomarker contributing independently. In a case-control study, nearly half of detected cancer signals came from methylation alone, while additional cases were identified through protein-only and combined biomarker signals, supporting broader and earlier detection.

Separately, long-term results from the DETECT-A study—recognized with an AACR award—demonstrated the potential clinical impact of blood-based MCED testing. The study identified multiple cancer types, including those without routine screening, and reported that patients diagnosed at early stages remained alive and cancer-free after several years of follow-up.

Abbott emphasized that multi-cancer early detection could play a significant role in improving screening, particularly as a large proportion of cancers currently lack standard screening methods. The Cancerguard test, which uses a simple blood draw, is designed to detect multiple cancers at early stages, though it has not yet received regulatory approval.
PRNewswire

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European Investor 04-18-26

Abbott Laboratories reported first-quarter 2026 results in line with expectations, posting GAAP diluted earnings per share of $0.61 and adjusted EPS of $1.15, up 6% year-over-year, while total sales rose 7.8% on a reported basis.

A key highlight of the quarter was the completion of Abbott’s acquisition of Exact Sciences, positioning the company as a major player in the rapidly growing oncology diagnostics market and adding a new high-growth segment to its portfolio.

Abbott maintained a positive outlook for 2026, projecting full-year comparable sales growth of 6.5% to 7.5% and adjusted EPS of $5.38 to $5.58, including a modest dilution impact from the acquisition. The company also reported progress across its medical technology pipeline, including advancements in cardiovascular devices and diabetes management solutions, supporting expectations for accelerating growth through the year.
PRNewswire

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Global Finance News 04-17-26

Abbott announced a partnership with Flatiron Health to integrate its Precision Oncology portfolio into the OncoEMR® platform.

The integration enables oncologists to order diagnostic tests and access results directly within their existing clinical workflow, improving efficiency and reducing administrative burden.

The move expands access to Abbott’s oncology tests across Flatiron’s network of more than 1,600 cancer care centers and 4,700 providers in North America.

The companies said the collaboration will support faster, data-driven treatment decisions and enhance personalized cancer care by embedding diagnostics into everyday clinical practice.
PRNewswire

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WS Investor 03-30-26

Abbott announced it has completed the acquisition of Exact Sciences, strengthening its position in cancer screening and diagnostics.

The deal expands Abbott’s portfolio with leading products such as Cologuard and Oncotype DX, while adding a pipeline focused on early cancer detection and personalized treatment.

The acquisition positions Abbott to compete in a fast-growing $60 billion market, supporting its strategy to advance preventative and precision healthcare solutions.
PRNewswire

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WS Investor 03-23-26

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