健康2026/09/23@HealthDesk
FDA批准雅培Volt脉冲场消融系统用于房颤治疗
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2025/12/22已确认可信度 84%275天前新闻稿的发稿地和日期为“伊利诺伊州雅培园区，2025年12月22日”，并称雅培“于今日宣布”FDA^[5]已批准Volt PFA System（FDA自身记录给出的决定日期为2025年12月19日）。
FDA批准了雅培的Volt脉冲场消融系统，这是一种可标测、起搏并消融的“篮中球囊”导管，用于治疗阵发性和持续性心房颤动。该批准基于在40家中心开展、纳入392名患者的VOLT-AF IDE研究。
0.81
健康2026/09/23@HealthDesk
FDA Authorizes Abbott's Libre Duo Glucose-Ketone Sensor
Abbott Laboratories…1360 South Loop Road, Alameda, Alameda County, California, 94502, United States
开始于 2026/08/25已确认可信度 87%29天前The 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.
0.72
健康2026/09/23@HealthDesk
Abbott's Amulet 360 LAA Occluder Wins CE Mark
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2026/08/27已确认可信度 88%27天前The 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.
0.70
健康2026/09/23@HealthDesk
FDA Approves Icotyde, the First Oral IL-23 Receptor Pill for Psoriasis
Johnson & Johnson…Spring House, Lower Gwynedd Township, Montgomery County, Pennsylvania, 19477, United States
开始于 2026/03/17 20:12已确认可信度 88%190天前The FDA's^[4] approval letter for NDA 220149 says the application "is approved, effective on the date of this letter" and was electronically signed "03/17/2026 04:12:23 PM" (Eastern, 20:12 UTC); J&J announced it the next morning: "SPRING HOUSE, Pa. (March 18, 2026) - ... announced today that the U.S. Food and Drug Administration (FDA) has approved ICOTYDE".
The FDA approved Johnson & Johnson's Icotyde (icotrokinra), a once-daily pill and the first targeted oral peptide to block the IL-23 receptor, for moderate-to-severe plaque psoriasis in adults and children 12 and older weighing at least 40 kg.
0.63
健康2026/09/23@HealthDesk
Abbott Corrects FreeStyle Libre 3 Sensors Over False Low Readings
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2025/11/24已确认可信度 88%303天前Abbott'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.
0.62
健康2026/09/23@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
开始于 2026/08/20已确认可信度 86%34天前The 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
0.61
健康2026/09/23@HealthDesk
Abbott Agrees to Buy Exact Sciences for $21 Billion
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2025/11/20已确认可信度 86%307天前The release is datelined "ABBOTT PARK, Ill., and MADISON, Wis., Nov. 20, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) and Exact Sciences (NASDAQ: EXAS) today announced a definitive agreement".^[1]
Abbott agreed to buy Cologuard maker Exact Sciences for $105 a share in cash, a total equity value of about $21 billion, to enter cancer screening and precision oncology diagnostics.
$21B
0.60
健康2026/09/23@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
开始于 2027/03/31预估延期3个月可信度 77%189天后Lilly "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.
0.60
健康2026/09/23@HealthDesk
Abbott and Google Partner on Lingo Glucose Insights and AI Coaching
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2026/08/11已确认可信度 85%43天前The 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.
0.60
健康2026/09/23@HealthDesk
Abbott Reports Q2 2026 Results and Raises Full-Year EPS Guidance
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2026/07/16 13:00已确认可信度 86%69天前The release, datelined "ABBOTT^[5] PARK, Ill., July 16, 2026", says "Abbott will live-webcast its second-quarter earnings conference call ... at 8 a.m. Central time today", so the pin is 8 a.m. CDT (13:00 UTC) on 16 July 2026.
Abbott posted second-quarter sales of $12.59 billion, up 13.0% reported and 4.8% comparable, and adjusted EPS of $1.31, and raised its 2026 adjusted EPS guidance to $5.45 to $5.60.
0.60
健康2026/09/20@HealthDesk
Elecoglipron's Phase 3 Trial in Type 2 Diabetes Mellitus Reads Out
AstraZeneca…Cambridge, United Kingdom
开始于 2028/07/05预估可信度 50%1.8年后ClinicalTrials.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.
0.60
健康2026/09/20@HealthDesk
Maridebart Cafraglutide's Phase 3 Trial in Heart Failure With Preserved Ejection Fraction Reads Out
Amgen…Thousand Oaks, United States
开始于 2028/06/30预估可信度 50%1.8年后ClinicalTrials.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.
0.60

The 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).

开始: 2026年9月8日可信度 90%来自来源

FDA Approves Abbott's TactiFlex Duo Ablation Catheter

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.

Abbott announced FDA approval of the TactiFlex Duo Ablation Catheter, Sensor Enabled, for challenging cases of atrial fibrillation, with broader commercial adoption across the U.S. in the coming weeks^[1][2]
The FDA approved it on 4 September 2026 as a panel-track supplement (S028) to the TactiFlex PMA P220013, for drug-refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter with a compatible RF or pulsed field generator and 3D mapping system^[3]
Physicians can use pulsed field ablation, radiofrequency energy or a combination in one procedure, and Abbott's EnSite X EP System gives real-time feedback on lesion formation through its PFA Index^[1]
In the FlexPulse study behind the approval, 180 patients underwent ablation with pulmonary vein isolation achieved in all; the primary safety endpoint rate was 1.7%, the primary effectiveness endpoint 74.6% at 12 months, and freedom from documented AF/AFL/AT recurrence 77.4%^[4]
Abbott calls it the company's fifth major electrophysiology approval in just over a year, after the Amulet 360 and TactiFlex Duo CE Marks this year and U.S. and European approvals of the Volt PFA System in 2025^[1]
TactiFlex Duo received CE Mark in Europe in January 2026 on the FOCALFLEX study, with the first EU commercial cases that week, and the FDA granted it Breakthrough Device Designation in October 2025 for treating ventricular tachycardia with PFA^[5]

@HealthDesk

参考资料 5可信度 86%

第一项始终是图钉的来源。总体可信度是各份资料对上方所用开始和结束时间支持程度的加权平均；资料每比最新的一份旧 180 天，权重减半。

[1]90%
abbott.mediaroom.com/2026-09-08-Abbott-receives-FDA-approval-for-its-TactiFlex-TM-Duo-Ablation-Catheter-to-treat-people-with-abnormal-heart-rhythms
abbott.mediaroom.com· 发布于 2026年9月23日· 开始 2026年9月8日 ✓· 占评分 24%
The 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).
[2]72%
Abbott Gains FDA Approval for Dual-Energy Ablation Catheter
mpo-mag.com· 发表于 2026年9月8日· 占评分 23%
Medical Product Outsourcing's trade-press report of the approval and the U.S. rollout in the coming weeks.^[1]
[3]95%
Premarket Approval (PMA) P220013/S028: TactiFlex Duo Ablation Catheter, Sensor Enabled
accessdata.fda.gov· 发表于 2026年9月4日· 占评分 22%
The FDA's PMA database entry for the TactiFlex Duo panel-track supplement: applicant Abbott Medical, decision date 09/04/2026, and the approved indication.
[4]88%
Safety and Effectiveness of a Novel Dual-Energy Radiofrequency/Pulsed Field Ablation Catheter: 12 Month Results of the FlexPulse Study (EP Europace)
academic.oup.com· 发表于 2026年8月29日· 占评分 22%
The peer-reviewed FlexPulse results the release cites as the basis for FDA^[3] approval, with the 12-month safety and effectiveness figures.
[5]80%
Abbott receives CE Mark for the TactiFlex Duo Ablation Catheter to treat patients with abnormal heart rhythms
abbott.mediaroom.com· 发表于 2026年1月20日· 占评分 9%
Abbott's earlier release on the European CE Mark, the FOCALFLEX study and the October 2025 FDA^[3] Breakthrough Device Designation for VT.

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1FDA Approves Abbott's TactiFlex Duo Ablation Catheter开始时为 US$105.52

健康2026/09/23@HealthDesk
FDA批准雅培Volt脉冲场消融系统用于房颤治疗
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2025/12/22已确认可信度 84%275天前新闻稿的发稿地和日期为“伊利诺伊州雅培园区，2025年12月22日”，并称雅培“于今日宣布”FDA^[5]已批准Volt PFA System（FDA自身记录给出的决定日期为2025年12月19日）。
FDA批准了雅培的Volt脉冲场消融系统，这是一种可标测、起搏并消融的“篮中球囊”导管，用于治疗阵发性和持续性心房颤动。该批准基于在40家中心开展、纳入392名患者的VOLT-AF IDE研究。
0.81
健康2026/09/23@HealthDesk
FDA Authorizes Abbott's Libre Duo Glucose-Ketone Sensor
Abbott Laboratories…1360 South Loop Road, Alameda, Alameda County, California, 94502, United States
开始于 2026/08/25已确认可信度 87%29天前The 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.
0.72
健康2026/09/23@HealthDesk
Abbott's Amulet 360 LAA Occluder Wins CE Mark
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2026/08/27已确认可信度 88%27天前The 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.
0.70
健康2026/09/23@HealthDesk
FDA Approves Icotyde, the First Oral IL-23 Receptor Pill for Psoriasis
Johnson & Johnson…Spring House, Lower Gwynedd Township, Montgomery County, Pennsylvania, 19477, United States
开始于 2026/03/17 20:12已确认可信度 88%190天前The FDA's^[4] approval letter for NDA 220149 says the application "is approved, effective on the date of this letter" and was electronically signed "03/17/2026 04:12:23 PM" (Eastern, 20:12 UTC); J&J announced it the next morning: "SPRING HOUSE, Pa. (March 18, 2026) - ... announced today that the U.S. Food and Drug Administration (FDA) has approved ICOTYDE".
The FDA approved Johnson & Johnson's Icotyde (icotrokinra), a once-daily pill and the first targeted oral peptide to block the IL-23 receptor, for moderate-to-severe plaque psoriasis in adults and children 12 and older weighing at least 40 kg.
0.63
健康2026/09/23@HealthDesk
Abbott Corrects FreeStyle Libre 3 Sensors Over False Low Readings
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2025/11/24已确认可信度 88%303天前Abbott'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.
0.62
健康2026/09/23@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
开始于 2026/08/20已确认可信度 86%34天前The 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
0.61
健康2026/09/23@HealthDesk
Abbott Agrees to Buy Exact Sciences for $21 Billion
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2025/11/20已确认可信度 86%307天前The release is datelined "ABBOTT PARK, Ill., and MADISON, Wis., Nov. 20, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) and Exact Sciences (NASDAQ: EXAS) today announced a definitive agreement".^[1]
Abbott agreed to buy Cologuard maker Exact Sciences for $105 a share in cash, a total equity value of about $21 billion, to enter cancer screening and precision oncology diagnostics.
$21B
0.60
健康2026/09/23@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
开始于 2027/03/31预估延期3个月可信度 77%189天后Lilly "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.
0.60
健康2026/09/23@HealthDesk
Abbott and Google Partner on Lingo Glucose Insights and AI Coaching
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2026/08/11已确认可信度 85%43天前The 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.
0.60
健康2026/09/23@HealthDesk
Abbott Reports Q2 2026 Results and Raises Full-Year EPS Guidance
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2026/07/16 13:00已确认可信度 86%69天前The release, datelined "ABBOTT^[5] PARK, Ill., July 16, 2026", says "Abbott will live-webcast its second-quarter earnings conference call ... at 8 a.m. Central time today", so the pin is 8 a.m. CDT (13:00 UTC) on 16 July 2026.
Abbott posted second-quarter sales of $12.59 billion, up 13.0% reported and 4.8% comparable, and adjusted EPS of $1.31, and raised its 2026 adjusted EPS guidance to $5.45 to $5.60.
0.60
健康2026/09/20@HealthDesk
Elecoglipron's Phase 3 Trial in Type 2 Diabetes Mellitus Reads Out
AstraZeneca…Cambridge, United Kingdom
开始于 2028/07/05预估可信度 50%1.8年后ClinicalTrials.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.
0.60
健康2026/09/20@HealthDesk
Maridebart Cafraglutide's Phase 3 Trial in Heart Failure With Preserved Ejection Fraction Reads Out
Amgen…Thousand Oaks, United States
开始于 2028/06/30预估可信度 50%1.8年后ClinicalTrials.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.
0.60

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参考资料 5可信度 86%

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