Academica Weekly: The Primary Record for the Week Ending 4 October 2026

Academica Weekly: The Primary Record for the Week Ending 4 October 2026

Trial registrations, clearances, recalls, guidance, safety reports, device listings, and insider filings — assembled from the primary sources with no editor in the loop.

The week of 28 September 2026 to 4 October 2026: 41 Phase 3 trial registrations; 91 Phase 2 trial registrations; 7 recall events; 157 510(k) clearances; 216 new Health Canada device licences; 4,237 ARTG device entries; 493 open-market insider purchases.

41 Phase 3 trial registrations
91 Phase 2 trial registrations
7 recall events
157 510(k) clearances
71Phase 1 registrations91Phase 2 registrations41Phase 3 registrations45Phase 4 registrations157510(k) clearances269PMA decisions7recall events352,949adverse event reports439,212device event reports25,552device listings4,237ARTG device entries216new device licences7label effective dates65,735new provider enumerations15,384,974industry payments95medtech patent grants123,818literature records493open-market insider purchases
One pill per source with new rows this week

Source Ledger

The latest event date each source holds, measured against its expected publication cadence. A stale source keeps its ledger line and loses its section.

SourceLatest eventState
ClinicalTrials.govPhase 1 · Phase 2 · Phase 3 · Phase 42 October 2026Current
FDA 510(k)19 September 202615 days behind
FDA PMA18 September 2026Current
FDA recalls29 September 2026Current
FDA guidance25 September 2026Current
FAERS30 June 2026Current
MAUDE31 August 2026Current
GUDID26 July 202670 days behind
TGA ARTG2 October 2026Current
Health Canada2 October 2026Current
FDA drug labels1 October 20263 days behind
NPPES12 September 2026Current
Open Payments31 December 2024642 days behind
USPTO10 February 2026236 days behind
PubMed3 October 2026Current
SEC Form 42 October 2026Current

Phase 1 Trials

71 Phase 1 registrations this week; the 10 below lead the list.

NCTStudySponsorEnrollmentPosted
CD19 CAR-T Therapy for Refractory Childhood-Onset Systemic Lupus ErythematosusSeoul National University Hospital8
A Study to Learn About the Safety of BIIB147 and Its Effects in Adults With Amyotrophic Lateral Sclerosis (ALS)Biogen69
A Research Study Investigating How Adults With Overweight or Obesity, With or Without Type 2 Diabetes, Tolerate Switching to a New Treatment (Zenagamtide) From Their Current SemaglNovo Nordisk A/S60
A Clinical Trial of V175 and V175A in Healthy AdultsMerck Sharp & Dohme LLC564
First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE-4D Imaging in Healthy VolunteersNational Institute of Mental Health (NIMH)40
A Study to Explore the Tissue Level Effects of Remibrutinib in Adults With Moderate to Severe HSNovartis Pharmaceuticals30
A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Impaired Renal Function and Participants on HemodialysisIncyte Corporation24
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic ImpairmentBeOne Medicines24
Safety and Preliminary Efficacy of Adipose-Derived Stem Cell Secretome in Frailty (VinVital)Vinmec Research Institute of Stem Cell and Gene Technology20
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwSerum Institute of India Pvt. Ltd.186

Phase 2 Trials

91 Phase 2 registrations this week; the 10 below lead the list.

NCTStudySponsorEnrollmentPosted
The Clinical Trial of Tamibarotene for Patients With HFpEF (RELIEF Trial)Nagoya University90
A Phase II Study of Ivonescimab in Combination With GEMOX as Neoadjuvant and Conversion Therapy for Biliary Tract CancerHaitao Zhao, MD87
Arsenic Trioxide Combined With Chemotherapy for Relapsed SHH-Activated and/or TP53-Mutant MedulloblastomaSun Yat-Sen Memorial Hospital of Sun Yat-Sen University78
A Clinical Study to Assess Safety, Efficacy and Pharmacodynamic Profile of GNT0004 in Duchenne Muscular DystrophyGenethon77
A Study to Learn About the Safety of BIIB147 and Its Effects in Adults With Amyotrophic Lateral Sclerosis (ALS)Biogen69
Topical Dexamethasone/Diclofenac Hydrogel for Postoperative Pain and Swelling in Facial Soft Tissue InjuriesThamar University52
Multicenter, Single-Arm, Prospective Phase II Study of Neoadjuvant Cryo-Thermal Ablation Combined With Toripalimab and Chemotherapy for Resectable Stage IB-IIIB Non-Small Cell LungWest China Hospital40
Fecal Microbiota Transplantation Combined With NALIRIFOX Plus Serplulimab as First-line Treatment for Advanced or Metastatic Pancreatic Ductal Adenocarcinoma.Tianjin Medical University Cancer Institute and Hospital40
SHR-A1811 Versus Trastuzumab Plus Pertuzumab in ctDNA-Positive HER2-Positive Early Breast Cancer After Pathologic Complete ResponseFudan University358
A Prospective Clinical Study of Zeprumetosta in Patients With Relapsed or Refractory Cutaneous T-Cell LymphomaPeking University First Hospital33

Phase 3 Trials

41 Phase 3 registrations this week; the 10 below lead the list.

NCTStudySponsorEnrollmentPosted
A Clinical Study to Assess Safety, Efficacy and Pharmacodynamic Profile of GNT0004 in Duchenne Muscular DystrophyGenethon77
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD TreatmentIntra-Cellular Therapies, Inc.705
A Study to Evaluate the Efficacy and Safety of Proximod in Patients With Rheumatoid ArthritisJiankuan (Suzhou) Biotechnology Company Limited590
Topical Dexamethasone/Diclofenac Hydrogel for Postoperative Pain and Swelling in Facial Soft Tissue InjuriesThamar University52
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose WeightBoehringer Ingelheim350
Study Interchangeability Hep-B Vaccine Administered at Birth DosePT Bio Farma270
Use of Preoperative Gas in Eyes With Macula-off Rhegmatogenous Retinal Detachment (RRD)Wills Eye190
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Regeneron Pharmaceuticals1,500
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial Ovarian CancerAstraZeneca950
Prophylactic Antibiotic Duration in Head and Neck Cancer Surgery: A Pragmatic, Open-Label, Randomized Superiority Trial (PROTECT-HN Trial)AC Camargo Cancer Center80

Phase 4 Trials

45 Phase 4 registrations this week; the 10 below lead the list.

NCTStudySponsorEnrollmentPosted
Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal AnesthesiaAssiut University99
Nortriptyline Compared With Amitriptyline for Migraine Prevention at SQUHSultan Qaboos University90
Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean SectionAssiut University90
A Study of QL1706 Combined With OH2 Injection in Perioperative Treatment of Stage III Resectable Acral MelanomaPeking University Cancer Hospital & Institute76
Reconsidering Long-Term Apirin in the Elderly in Secondary Prevention of Coronary Artery Disease NorwayVestre Viken Hospital Trust7,000
Intraosseous Tranexamic Acid for Reducing Blood Loss in Total Knee ArthroplastyThe Second Affiliated Hospital of Kunming Medical University70
Clinical Lid Eradication of Antifungal-Responsive FUNGUS StudyBrent Kramer60
Low-Volume PENG Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip ArthroplastyAin Shams University60
Tobramycin Nebulization to Prevent Multidrug-Resistant Ventilator-Associated PneumoniaSecond Affiliated Hospital, Zhejiang University, School of Medicine574
Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain ManagementAditi Talkad48

510(k) Clearances

157 510(k) clearances this week; the 10 below lead the list.

K numberDeviceApplicantClassDecision
Dynamis Pro FamilyFotona D.O.O.2
SmartIPL_NI SystemLumenis Be, Ltd.2
Electric Scooter (FDB08, FDB08A, FDB12)Anhui JBH Medical Apparatus Co., Ltd.2
NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU Medical2
VacHeal Negative Pressure Wound Therapy SystemVacHeal, LLC2
Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.2
Drainage CatheterCanyon Medical, Inc.2
MINT MONO SuturesHans Biomed Corporation2
Deterioration Index Version 2Epic Systems Corporation2
Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.2

PMA Approvals

269 PMA decisions this week; the 10 below lead the list.

PMADeviceApplicantDecision
SURGIFOAM® Absorbable Gelatin SpongeFerrosan Meidcal Devices A/S
SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedAlliance, LLC
Novocure GmbH’s Optune GioNovocure, GmbH
Restylane® ContourQ-Med AB
Quattrode®; Octrode™; Penta™; Lamitrode™; Tripole™; TriCentrus™ Lead ExtensionsAbbott Medical
Epic™ Plus, Epic™ Plus Supra, Epic™ Max, Epic™ Elite, Epic™ Supra G3 Tissue Heart ValvesAbbott Medical
FoundationOne Liquid CDx (F1LCDx)Foundation Medicine, Inc.
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent - Microfibrillar FoIntegra LifeSciences Corporation
Guardant360 CDxGuardant Health, Inc.
INTEGRA ® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal RegeIntegra Lifesciences Corp.

Recalls

7 recall events this week.

FirmProductReasonCatalog rowsPosted
Tandem Diabetes Care, Inc.Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 0038915247A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM) sen1
Philips North America LlcPhilips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.1
Penumbra Inc.Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Software Version: N/A Product DescriptionDue to manufacturing issues reperfusion catheters may fracture.1
Olympus Corporation of the AmericasOlympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih OLYSENSE Hub SystemWhile in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.1
Spectrum Medical SRLBrand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software Version: N/A Product Description: The Quantum PureFlowDue to blood-to-glycol leak in the heat exchanger.2
Percussionaire CorporationIntrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction ManualLabeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter an7
Micro Therapeutics, Inc.Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield Technology consists of a permanent implant comDue to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.1

Drug Safety Reports (FAERS)

352,949 adverse event reports this week; the 10 below lead the list.

ReactionReports
Off label use19,437
Drug ineffective17,826
Nausea13,583
Product dose omission issue12,230
Diarrhoea12,101
Death11,969
Fatigue11,899
Pruritus10,348
Headache9,032
Meningioma8,392

Device Safety Reports (MAUDE)

439,212 device event reports this week; the 10 below lead the list.

BrandManufacturerEvents
FreeStyle Libre 247,720
FreeStyle Libre 326,371
FreeStyle Libre 3 Plus22,199
Dexcom G7 Continuous Glucose Monitoring System21,690
FreeStyle Libre 2 Plus18,829
Medline16,603
Inset Guard16,392
FreeStyle Libre 14 Day9,474
t:slim X2 Insulin Pump with Control-IQ Technology9,380
t:slim X2 Insulin Pump with Control-IQ+ Technology7,573

Device Listings (GUDID)

25,552 device listings this week; the 10 below lead the list.

BrandCompanyGMDNPublished
Aligned Medical SolutionsAligned Medical SolutionsGeneral surgical procedure kit, non-medicated, single-use
Aligned Medical SolutionsAligned Medical SolutionsGeneral surgical procedure kit, non-medicated, single-use
MyCareLink™Medtronic, Inc.Cardiac pulse generator reader, home-use
MillenniumAvalign Technologies, Inc.Tendon stripper
MillenniumAvalign Technologies, Inc.Orthopaedic joint/limb rongeur
Aligned Medical SolutionsAligned Medical SolutionsOrthopaedic surgical procedure kit, non-medicated, single-use
Aligned Medical SolutionsAligned Medical SolutionsOphthalmic surgical procedure kit, non-medicated, single-use
Medtronic Reusable InstrumentsMedtronic Sofamor Danek, Inc.Surgical screwdriver, reusable
Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing
Aligned Medical SolutionsAligned Medical SolutionsGeneral surgical procedure kit, non-medicated, single-use

Australia (TGA ARTG)

4,237 ARTG device entries this week; the 10 below lead the list.

BrandManufacturerSponsorClassEffective
GiaCovidien llcMedtronic Australasia Pty LtdClass III
NylusTI Medical Private LimitedDevice Technologies Australia Pty LtdClass IIb
Dental Cone-beam Computed TomographyHefei Meyer Optoelectronic Technology IncMDSS AU Pty LtdClass IIb
NylusTI Medical Private LimitedDevice Technologies Australia Pty LtdClass IIb
NylusTI Medical Private LimitedDevice Technologies Australia Pty LtdClass IIb
NylusTI Medical Private LimitedDevice Technologies Australia Pty LtdClass IIb
NylusTI Medical Private LimitedDevice Technologies Australia Pty LtdClass IIb
Dental Cone-beam Computed TomographyHefei Meyer Optoelectronic Technology IncMDSS AU Pty LtdClass IIb
NylusTI Medical Private LimitedDevice Technologies Australia Pty LtdClass IIb
Solus 910TI Medical Private LimitedDevice Technologies Australia Pty LtdClass III

Canada (Health Canada MDALL)

216 new device licences this week; the 10 below lead the list.

DeviceCompanyClassLicensed
Enteral Funnel Enfit Transition Connector with CapCedic SRL2
Instrument R1DW&H Dentalwerk Burmoos GmbH2
Instrument Set SpecialW&H Dentalwerk Burmoos GmbH2
Instrument Set EndoW&H Dentalwerk Burmoos GmbH2
Instrument Set ParoW&H Dentalwerk Burmoos GmbH2
Instrument Set ExW&H Dentalwerk Burmoos GmbH2
Instrument Set Implant/Crestal AW&H Dentalwerk Burmoos GmbH2
Instrument Set Implant/Crestal PW&H Dentalwerk Burmoos GmbH2
Instrument B1W&H Dentalwerk Burmoos GmbH2
Instrument B2LW&H Dentalwerk Burmoos GmbH2

Drug Labels

7 label effective dates this week; the 4 below lead the list.

BrandGenericManufacturerEffective
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm DuskSPF50Grace And Fire USA Inc.
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm BejewelledSPF50Grace And Fire USA Inc.
TemazepamTemazepamPreferred Pharmaceuticals Inc.
childrens allergy reliefLoratadineCVS Woonsocket Prescription Center, Incorporated

Workforce (NPPES)

65,735 new provider enumerations this week; the 10 below lead the list.

StateNew providersOrganizations
CA10,3671,218
TX4,4341,065
FL4,2731,243
NY3,557566
MI2,928406
OH2,899280
IL1,959466
NC1,780453
PA1,777373
MD1,742295

Industry Payments (Open Payments)

15,384,974 industry payments this week; the 10 below lead the list.

PayerTotal (USD)Payments
BioNTech SE180,558,679164
AbbVie Inc.156,382,6831,720,745
Stryker Corporation132,155,940162,439
Medtronic, Inc.117,649,217342,148
Arthrex, Inc.104,199,46449,443
Edge Endo LLC91,139,12711
Zimmer Biomet Holdings, Inc.83,904,35132,760
Intuitive Surgical, Inc.72,225,869116,855
Takeda Pharmaceuticals U.S.A., Inc.71,616,187171,595
Advanced Accelerator Applications63,931,988167

Patents (USPTO, A61)

95 medtech patent grants this week; the 10 below lead the list.

AssigneeGrants
Globus Medical, Inc.8
Hytto Pte. Ltd.2
Medicrea International2
Koninklijke Philips N.V.2
Warsaw Orthopedic, Inc.2
Neodyne Biosciences, Inc.1
GlaxoSmithKline Intellectual Property Development Limited1
University of Florida Research Foundation, Incorporated1
Intuitive Surgical Operations, Inc.1
Universitätsspital Basel1

Literature (PubMed)

123,818 literature records this week; the 10 below lead the list.

PMIDTitleJournalRevised
Recent advances in the molecular biology of growth-hormone secreting human pituitary tumours.Experimental and clinical endocrinology
USP26-mediated stabilization of RAD51 promotes endometrial cancer progression and limits ferroptosis.Frontiers in oncology
Cyclotorsion as a structural and functional biomarker of ocular and neuroophthalmic diseases.Acta biochimica Polonica
Divide or bridge? The heterogeneous effects of digital village participation on rural residents' happiness.Frontiers in psychology
Implementation of the World Health Organization's Package of Essential Noncommunicable Disease Interventions: an overview of reviews.Public health reviews
Associations between cognitive reserve, iron deposition in the basal ganglia, and cognitive function in mild cognitive impairment.Frontiers in psychology
Post-abortion contraceptive uptake among women seeking care for incomplete or induced abortions in Northern Ethiopia: a facility-based cross-sectional study in a humanitarian setting.Frontiers in public health
Factors associated with risk perception among school and nursery school teachers concerning potential health effects of exposure to electromagnetic fields.Frontiers in public health
ZmEIL2 positively regulates drought tolerance in maize by modulating stomatal movement, hormonal homeostasis, and antioxidant defense.Frontiers in plant science
European society for organ transplantation clinical practice guideline on prevention and treatment of chronic lung allograft dysfunction.Transplant international : official journal of the European Society for Organ Transplantation

Literature by Subject (MeSH)

210,364 annotated literature records this week; the 10 below lead the list.

MeSH headingArticles
Humans 81,392
Female 41,483
Male 38,043
Animals 23,943
Adult 21,547
Middle Aged 19,831
Aged 15,069
Adolescent 8,431
Young Adult 8,345
Mice 8,122

Insider Buying (Form 4)

493 open-market insider purchases this week; the 10 below lead the list.

TickerOwnerTradedSharesValue (USD)
Wang Ching-Dong4,545,30610,329,903,316,818
Baker Bros. Advisors LP1,908,029154,118,138
Ault Milton C Iii18,00092,412,000
Berkshire Hathaway Inc.642,82152,441,313
N/AManufacturers Life Reinsurance Ltd2,442,08739,997,992
Conifer Management, L.L.C.133,47232,510,537
Nippon Life Insurance Co805,78227,519,616
Sr One Capital Management, LLC1,600,00027,200,000
George Simeon1,600,00027,200,000
N/AManulife (International) Ltd1,476,11825,998,869

Academica Weekly is assembled and published automatically each week. This issue covers 28 September 2026 to 4 October 2026 and was built on 4 October 2026.

Index

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