FDA Approves Abbott's Volt PFA System for AFib

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• Health09/23/2026@HealthDesk

  FDA Approves Abbott's TactiFlex Duo Ablation Catheter

  Abbott Laboratories·…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States

  Starts 09/08/2026CONFIRMED86% CONFIDENCE16 days agoThe release is datelined "ABBOTT PARK, Ill., Sept. 8, 2026" and says Abbott "announced today it has received U.S. Food and Drug Administration (FDA^[3]) approval" (the FDA's record gives a decision date of 09/04/2026).

  The FDA approved Abbott's TactiFlex Duo, a catheter that can deliver pulsed field ablation, radiofrequency energy or both in one procedure to treat complex atrial fibrillation. The approval rested on the FlexPulse IDE study.

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• Health09/23/2026@HealthDesk

  FDA Authorizes Abbott's Libre Duo Glucose-Ketone Sensor

  Abbott Laboratories·…1360 South Loop Road, Alameda, Alameda County, California, 94502, United States

  Starts 08/25/2026CONFIRMED87% CONFIDENCE30 days agoThe release is datelined "ABBOTT PARK, Ill., Aug. 25, 2026" and says Abbott "today announced U.S. Food and Drug Administration (FDA^[2][3]) authorization of its Libre Duo 10 Day system"; the FDA's De Novo record gives the same decision date, 08/25/2026.

  The FDA authorized Abbott's Libre Duo 10 Day, the first wearable to continuously track both glucose and ketones, which alerts people with diabetes aged 2 and older to rising ketones before diabetic ketoacidosis.

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• Health09/23/2026@HealthDesk

  Abbott's Amulet 360 LAA Occluder Wins CE Mark

  Abbott Laboratories·…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States

  Starts 08/27/2026CONFIRMED88% CONFIDENCE28 days agoThe release is datelined "ABBOTT PARK, Ill., Aug. 27, 2026" and says Abbott "announced today it has received CE Mark for the Amulet 360 Left Atrial Appendage (LAA) Occluder".^[1]

  Abbott's next-generation Amulet 360 left atrial appendage occluder received CE Mark to cut stroke risk in non-valvular atrial fibrillation, with the first European implants done in Frankfurt, Lubeck and Aarhus.

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• Health09/23/2026@HealthDesk

  Abbott Corrects FreeStyle Libre 3 Sensors Over False Low Readings

  Abbott Laboratories·…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States

  Starts 11/24/2025CONFIRMED88% CONFIDENCE304 days agoAbbott's release is datelined "ABBOTT PARK, Ill., Nov. 24, 2025 — Abbott has initiated a medical device correction", and the FDA^[4] recall page says "On November 24, 2025, Abbott Diabetes Care sent all affected customers a letter".

  Abbott began a medical device correction for about 3 million FreeStyle Libre 3 and Libre 3 Plus sensors in the U.S. after internal testing found some give incorrect low glucose readings, an issue it linked to 736 severe adverse events and seven deaths worldwide. The FDA later made it a Class I recall.

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• Health09/20/2026@HealthDesk

  Maridebart Cafraglutide's Phase 3 Trial in Heart Failure With Preserved Ejection Fraction Reads Out

  Amgen·…Thousand Oaks, United States

  Starts 06/30/2028ESTIMATED50% CONFIDENCEin 1.8 yearsClinicalTrials.gov^[1] lists 2028-06-30 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.

  Amgen's phase 3 trial of Maridebart Cafraglutide in heart failure with preserved ejection fraction reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 5,056 participants. This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.

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• Health09/23/2026@HealthDesk

  Abbott and Google Partner on Lingo Glucose Insights and AI Coaching

  Abbott Laboratories·…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States

  Starts 08/11/2026CONFIRMED85% CONFIDENCE44 days agoThe release is datelined "ABBOTT PARK, Ill., Aug. 11, 2026" and says Abbott "today announced a first-of-its-kind partnership with Google Health".^[1]

  Abbott and Google Health launched a multi-year partnership to bring glucose data from Abbott's over-the-counter Lingo sensor into the Google Health app, where Google's AI Health Coach will use it for personalized advice. The deal includes one of the largest real-world metabolic health studies.

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• Health09/20/2026@HealthDesk

  BGF MDI 320/14.4/9.6 μG's Phase 3 Trial in COPD Reads Out

  AstraZeneca·…Cambridge, United Kingdom

  Starts 12/03/2027ESTIMATED50% CONFIDENCEin 1.2 yearsClinicalTrials.gov^[1] lists 2027-12-03 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.

  AstraZeneca's phase 3 trial of BGF MDI 320/14.4/9.6 μG in copd reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 5,000 participants. This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

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• Health09/23/2026@HealthDesk

  Lilly Submits Retatrutide to the FDA for Approval

  Eli Lilly·…Eli Lilly and Company Corporate Center, East McCarty Street, Indianapolis, Indiana 46206, United States

  Starts 03/31/2027ESTIMATED3 months late77% CONFIDENCEin 188 daysLilly "plans to subsequently submit retatrutide in Q1 2027 for U.S. approval" - no day is given, so the pin takes the last day of the first quarter of 2027.^[1]

  Lilly plans to file its Biologics License Application for retatrutide, the triple-hormone obesity shot that cut weight by up to 28.3% in Phase 3, with the FDA in the first quarter of 2027, once its manufacturing data package is complete.

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• Health09/20/2026@HealthDesk

  BI 690517's Phase 3 Trial in Kidney Disease, Chronic Reads Out

  Boehringer IngelheimIngelheim am Rhein, Mainz-Bingen district, Germany

  Starts 08/30/2028ESTIMATED50% CONFIDENCEin 1.9 yearsClinicalTrials.gov^[1] lists 2028-08-30 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.

  Boehringer Ingelheim's phase 3 trial of BI 690517 in kidney disease, chronic reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 11,000 participants. This study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart failure hospitalisation. After a run-in period, during which participants are confirmed to be receiving clinical

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• Health09/23/2026@HealthDesk

  Abbott Settles Gill Case and 2,000 NEC Formula Claims for $670M

  Abbott Laboratories·…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States

  Starts 08/20/2026CONFIRMED86% CONFIDENCE35 days agoThe release is datelined "ABBOTT PARK, Ill., Aug. 20, 2026" and the 8-K says "On August 20, 2026 ... Abbott entered into agreements to resolve the Gill lawsuit".^[1]

  Abbott agreed with three law firms to pay about $670 million to settle the Gill case, a $495 million St. Louis jury award, and NEC claims for about 2,000 other preterm infants fed its specialty formulas. About 1,700 lawsuits covering some 12,700 infants remain.

  $670M

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• Health09/20/2026@HealthDesk

  Vicadrostat's Phase 3 Trial in Heart Failure Reads Out

  Boehringer IngelheimIngelheim am Rhein, Mainz-Bingen district, Germany

  Starts 05/22/2028ESTIMATED50% CONFIDENCEin 1.7 yearsClinicalTrials.gov^[1] lists 2028-05-22 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.

  Boehringer Ingelheim's phase 3 trial of Vicadrostat in heart failure reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 6,000 participants. This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. T

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• Health09/20/2026@HealthDesk

  Elecoglipron's Phase 3 Trial in Type 2 Diabetes Mellitus Reads Out

  AstraZeneca·…Cambridge, United Kingdom

  Starts 07/05/2028ESTIMATED50% CONFIDENCEin 1.8 yearsClinicalTrials.gov^[1] lists 2028-07-05 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.

  AstraZeneca's phase 3 trial of Elecoglipron in type 2 diabetes mellitus reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 2,000 participants. The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.

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