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 11/24/2025CONFIRMED 88% CONFIDENCE303 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.
0.81
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 08/11/2026CONFIRMED 85% CONFIDENCE43 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.
0.76
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 09/08/2026CONFIRMED 86% CONFIDENCE15 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.
0.71
Health09/23/2026@HealthDesk
FDA Approves Abbott's Volt PFA System for AFib
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
Starts 12/22/2025CONFIRMED 84% CONFIDENCE275 days agoThe release is datelined "ABBOTT PARK, Ill., Dec. 22, 2025" and says Abbott "today announced" the FDA^[5] has approved the Volt PFA System (the FDA's own record gives a decision date of 12/19/2025).
The FDA approved Abbott's Volt pulsed field ablation system, a balloon-in-basket catheter that maps, paces and ablates, to treat paroxysmal and persistent atrial fibrillation. The approval rested on the 392-patient VOLT-AF IDE study at 40 centers.
0.66
Health09/20/2026@HealthDesk
Enicepatide's Phase 3 Trial in Obesity or Overweight Reads Out
RocheBasel, Canton of Basel-Stadt, Switzerland
Starts 07/24/2028ESTIMATED 50% CONFIDENCEin 1.8 yearsClinicalTrials.gov^[1] lists 2028-07-24 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
Roche's phase 3 trial of Enicepatide in obesity or overweight 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 assess the efficacy and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
0.66
Health09/20/2026@HealthDesk
Elecoglipron's Phase 3 Trial in Type 2 Diabetes Mellitus Reads Out
AstraZeneca…Cambridge, United Kingdom
Starts 07/05/2028ESTIMATED 50% 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.
0.65
Health09/23/2026@HealthDesk
J&J Signs a Drug-Pricing Deal With Trump and Joins TrumpRx
Johnson & Johnson World Headquarters, 1 Johnson and Johnson Plaza, New Brunswick, New Jersey 08933, United StatesJohnson & Johnson…
Starts 01/08/2026CONFIRMED 86% CONFIDENCE258 days agoJ&J's release is datelined "New Brunswick, N.J. – JANUARY 8, 2026" and says the company "today announced a voluntary agreement with the Trump Administration"; coverage followed on 9 January.^[1]
Johnson & Johnson signed a voluntary most-favored-nation drug-pricing agreement with the Trump administration, selling medicines through TrumpRx.gov and to Medicaid at prices comparable to other developed countries in exchange for an exemption from pharmaceutical tariffs, and announced two new US plants in Pennsylvania and North Carolina.
0.65
Health09/20/2026@TechDesk
Lilly's Foundayo (Orforglipron) Weight-Loss Pill Approved by FDA
Eli Lilly…Indianapolis, Indiana
Starts 04/01/2026CONFIRMED 85% CONFIDENCE175 days agoLilly^[3] and the FDA^[4] approval letter date the approval April 1, 2026.
The FDA approved Eli Lilly's Foundayo, a once-daily GLP-1 pill for weight loss that needs no food or water restrictions, with direct-to-consumer sales from April 6.
0.64
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 08/27/2026CONFIRMED 88% CONFIDENCE27 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.
0.64
Health09/23/2026@HealthDesk
Abbott Settles DOJ Infant Formula Claims for $385 Million
Abbott Laboratories…Sturgis, Saint Joseph County, Michigan, 49091, United States
Starts 09/14/2026CONFIRMED 88% CONFIDENCE9 days agoThe release is datelined "ABBOTT PARK, Ill., Sept. 14, 2026" and says Abbott "has reached an agreement"; the DOJ release is dated Monday, September 14, 2026.^[1]
Abbott will pay about $385 million ($384,999,040) to resolve Justice Department, state and whistleblower claims over powdered infant formula made at its Sturgis, Michigan, plant, the site of the 2022 recall. Abbott admits no liability, and the government has closed its criminal investigation.
$385M
0.64
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 189 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.
0.64
Health09/23/2026@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
Starts 03/17/2026 8:12PMCONFIRMED 88% CONFIDENCE190 days agoThe 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

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.

Start: Aug 25, 202690% CONFIDENCEfrom the source

FDA Authorizes Abbott's Libre Duo Glucose-Ketone Sensor

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.

The FDA authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 and older with diabetes, the first U.S. wearable to continuously monitor ketones and the first in the world to track ketones and glucose in one device, with readings every minute sent to a smartphone and alerts when ketones reach a concerning level^[2]
The FDA granted the De Novo request (DEN250049) to Abbott Diabetes Care of Alameda, California, on 25 August 2026, creating the classification "integrated continuous glucose ketone monitoring system"; the device had Breakthrough Device designation and six clinical studies enrolled more than 600 participants^[2][3]
Abbott says it is the first system to meet both the FDA's iCGM standard and the new iCGK standard, offers up to 10 days of wear, and will launch in the United States later this year^[1]
Abbott expects the sensor to work with Beta Bionics' iLet and Sequel Med Tech's twiist automated insulin delivery systems by the end of 2026 and with Insulet and Tandem devices in 2027, plus an exclusive MiniMed integration expected in 2027^[1]
The CE Mark in May 2026 covered two systems in Europe: Libre Duo with up to 15 days of wear for adults 18 and older, and Libre Duo 10 Day for ages 2 and older^[5]
Before the decision, MedTech Dive reported that wider access to ketone data raises questions about how to interpret and act on it, and that a Breakthrough T1D-led consensus set 3 mmol/L as "urgent high"^[4]

@HealthDesk

References 587% CONFIDENCE

The first entry is always the pin's source. Overall confidence is a weighted average of how firmly each reference supports the start and end times used above; a reference counts half as much for every 180 days older than the newest.

[1]90%
abbott.mediaroom.com/2026-08-25-Abbott-receives-FDA-authorization-for-worlds-first-dual-glucose-ketone-sensing-technology-for-people-with-diabetes
abbott.mediaroom.com· Posted Sep 23, 2026· Starts Aug 25, 2026 ✓· 23% of score
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.
[2]95%
FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar
fda.gov· Published Aug 25, 2026· 21% of score
The FDA's^[3] own press announcement of the De Novo authorization, with the clinical program, Breakthrough designation and who may use the device.
[3]93%
De Novo DEN250049: Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
accessdata.fda.gov· Published Aug 25, 2026· 21% of score
The FDA's^[2] De Novo database entry: requester Abbott Diabetes Care, Alameda, decision date 08/25/2026, granted, regulation 862.1354, product code SJD.
[4]74%
5 questions on Abbott's glucose-ketone sensors
medtechdive.com· Published Aug 19, 2026· 20% of score
MedTech Dive's pre-authorization look at how endocrinologists expect continuous ketone monitoring to be used, including the Breakthrough T1D urgent-high threshold.
[5]80%
Abbott secures CE Mark for world's first dual glucose-ketone sensing technology for people with diabetes
abbott.mediaroom.com· Published May 27, 2026· 15% of score
Abbott's earlier release on the European CE Mark covering Libre Duo and Libre Duo 10 Day.^[1]

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1FDA Authorizes Abbott's Libre Duo Glucose-Ketone Sensorstart was $116.13

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 11/24/2025CONFIRMED 88% CONFIDENCE303 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.
0.81
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 08/11/2026CONFIRMED 85% CONFIDENCE43 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.
0.76
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 09/08/2026CONFIRMED 86% CONFIDENCE15 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.
0.71
Health09/23/2026@HealthDesk
FDA Approves Abbott's Volt PFA System for AFib
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
Starts 12/22/2025CONFIRMED 84% CONFIDENCE275 days agoThe release is datelined "ABBOTT PARK, Ill., Dec. 22, 2025" and says Abbott "today announced" the FDA^[5] has approved the Volt PFA System (the FDA's own record gives a decision date of 12/19/2025).
The FDA approved Abbott's Volt pulsed field ablation system, a balloon-in-basket catheter that maps, paces and ablates, to treat paroxysmal and persistent atrial fibrillation. The approval rested on the 392-patient VOLT-AF IDE study at 40 centers.
0.66
Health09/20/2026@HealthDesk
Enicepatide's Phase 3 Trial in Obesity or Overweight Reads Out
RocheBasel, Canton of Basel-Stadt, Switzerland
Starts 07/24/2028ESTIMATED 50% CONFIDENCEin 1.8 yearsClinicalTrials.gov^[1] lists 2028-07-24 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
Roche's phase 3 trial of Enicepatide in obesity or overweight 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 assess the efficacy and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
0.66
Health09/20/2026@HealthDesk
Elecoglipron's Phase 3 Trial in Type 2 Diabetes Mellitus Reads Out
AstraZeneca…Cambridge, United Kingdom
Starts 07/05/2028ESTIMATED 50% 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.
0.65
Health09/23/2026@HealthDesk
J&J Signs a Drug-Pricing Deal With Trump and Joins TrumpRx
Johnson & Johnson World Headquarters, 1 Johnson and Johnson Plaza, New Brunswick, New Jersey 08933, United StatesJohnson & Johnson…
Starts 01/08/2026CONFIRMED 86% CONFIDENCE258 days agoJ&J's release is datelined "New Brunswick, N.J. – JANUARY 8, 2026" and says the company "today announced a voluntary agreement with the Trump Administration"; coverage followed on 9 January.^[1]
Johnson & Johnson signed a voluntary most-favored-nation drug-pricing agreement with the Trump administration, selling medicines through TrumpRx.gov and to Medicaid at prices comparable to other developed countries in exchange for an exemption from pharmaceutical tariffs, and announced two new US plants in Pennsylvania and North Carolina.
0.65
Health09/20/2026@TechDesk
Lilly's Foundayo (Orforglipron) Weight-Loss Pill Approved by FDA
Eli Lilly…Indianapolis, Indiana
Starts 04/01/2026CONFIRMED 85% CONFIDENCE175 days agoLilly^[3] and the FDA^[4] approval letter date the approval April 1, 2026.
The FDA approved Eli Lilly's Foundayo, a once-daily GLP-1 pill for weight loss that needs no food or water restrictions, with direct-to-consumer sales from April 6.
0.64
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 08/27/2026CONFIRMED 88% CONFIDENCE27 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.
0.64
Health09/23/2026@HealthDesk
Abbott Settles DOJ Infant Formula Claims for $385 Million
Abbott Laboratories…Sturgis, Saint Joseph County, Michigan, 49091, United States
Starts 09/14/2026CONFIRMED 88% CONFIDENCE9 days agoThe release is datelined "ABBOTT PARK, Ill., Sept. 14, 2026" and says Abbott "has reached an agreement"; the DOJ release is dated Monday, September 14, 2026.^[1]
Abbott will pay about $385 million ($384,999,040) to resolve Justice Department, state and whistleblower claims over powdered infant formula made at its Sturgis, Michigan, plant, the site of the 2022 recall. Abbott admits no liability, and the government has closed its criminal investigation.
$385M
0.64
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 189 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.
0.64
Health09/23/2026@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
Starts 03/17/2026 8:12PMCONFIRMED 88% CONFIDENCE190 days agoThe 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

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