Academica Weekly: The Primary Record for the Week Ending 25 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 19 October 2026 to 25 October 2026: 47 Phase 3 trial registrations; 111 Phase 2 trial registrations; 4 recall events; 118 510(k) clearances; 161 new Health Canada device licences; 289 open-market insider purchases.
47 Phase 3 trial registrations
111 Phase 2 trial registrations
4 recall events
118 510(k) clearances
65Phase 1 registrations111Phase 2 registrations47Phase 3 registrations29Phase 4 registrations118510(k) clearances289PMA decisions4recall events352,949adverse event reports444,608device event reports25,552device listings161new device licences1label effective dates61,063new provider enumerations15,384,974industry payments95medtech patent grants105,876literature records289open-market insider purchases
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.
| Source | Latest event | State |
|---|---|---|
| ClinicalTrials.govPhase 1 · Phase 2 · Phase 3 · Phase 4 | 23 October 2026 | Current |
| FDA 510(k) | 11 October 2026 | 14 days behind |
| FDA PMA | 9 October 2026 | Current |
| FDA recalls | 21 October 2026 | Current |
| FDA guidance | 14 October 2026 | 11 days behind |
| FAERS | 30 June 2026 | Current |
| MAUDE | 30 September 2026 | Current |
| GUDID | 26 July 2026 | 91 days behind |
| TGA ARTG | 14 October 2026 | 11 days behind |
| Health Canada | 22 October 2026 | 3 days behind |
| FDA drug labels | 19 October 2026 | 6 days behind |
| NPPES | 10 October 2026 | Current |
| Open Payments | 31 December 2024 | 663 days behind |
| USPTO | 10 February 2026 | 257 days behind |
| PubMed | 24 October 2026 | Current |
| SEC Form 4 | 23 October 2026 | Current |
Phase 1 Trials
65 Phase 1 registrations this week; the 10 below lead the list.
| NCT | Study | Sponsor | Enrollment | Posted |
|---|---|---|---|---|
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC36 Tablets for Oral Use in Adult Participants With Obesity or Overweight | Ascletis Pharma (China) Co., Limited | 86 | ||
| A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Doses of NH302 Injection in Healthy Participants | The Third Xiangya Hospital of Central South University | 62 | ||
| ESP Blocks in Breast Free Flaps | Carilion Clinic | 60 | ||
| Phase 1 Study of huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers | University of Pennsylvania | 6 | ||
| A Study of Single and Combination Lipase Dietary Supplements to Increase Fatty Acid Absorption in Generally Health Adults | Danisco | 50 | ||
| Immunogenicity and Safety of SYS6052 in the Participants Aged 40 Years and Above | CSPC Megalith Biopharmaceutical Co.,Ltd. | 496 | ||
| A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed | Institute of Medical Biology, Chinese Academy of Medical Sciences | 380 | ||
| A Phase I Study of HS-20093 in Combination With ZG006 With or Without Adebrelimab in Patients With ES-SCLC | Hansoh BioMedical R&D Company | 338 | ||
| A First-in-human Clinical Trial to Test if the Investigational Drug BNT3219 is Safe and Potentially Beneficial for People With Advanced Solid Tumors When Given Alone or Together Wi | BioNTech SE | 207 | ||
| Clinical Trial of CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection in the Treatment of Acute Respiratory Distress Syndrome | GuangZhou Cellgenes Biotechnology Co., Ltd. | 15 |
Phase 2 Trials
111 Phase 2 registrations this week; the 10 below lead the list.
| NCT | Study | Sponsor | Enrollment | Posted |
|---|---|---|---|---|
| Phase II Clinical Study on Preliminary Efficacy and Safety of ETD-001 Gel for Hypertrophic Scars | Etern Therapeutics Wuxi Limited | 90 | ||
| Phase 2 Study of Oral Epetraborole in Adults With Polycythemia Vera | AN2 Therapeutics, Inc | 75 | ||
| A Study on the Clinical Efficacy of Fumigation and Washing With Modified Astragalus and Cinnamon Twig Decoction With Five Herbs in the Treatment of Post-Chemotherapy Peripheral Neu | Emeishan Hospital of Traditional Chinese Medicine | 7 | ||
| Less Doses of Daratumumab Are Adequate to Achieve Response in Newly Diagnosed Multiple Myeloma | Tata Memorial Centre | 52 | ||
| A Study of Single and Combination Lipase Dietary Supplements to Increase Fatty Acid Absorption in Generally Health Adults | Danisco | 50 | ||
| Effects of Lumbrokinase DLBS1033 on D-Dimer, Interleukin-6, and Clinical Outcomes in Patients With Pneumonia and Sepsis | Universitas Sebelas Maret | 50 | ||
| Immunogenicity and Safety of SYS6052 in the Participants Aged 40 Years and Above | CSPC Megalith Biopharmaceutical Co.,Ltd. | 496 | ||
| Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients | Hikma Pharmaceuticals USA Inc. | 44 | ||
| Lean Mass Changes With Semaglutide in Adults With Type 1 Diabetes and Overweight/Obesity. | McGill University Health Centre/Research Institute of the McGill University Health Centre | 40 | ||
| A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed | Institute of Medical Biology, Chinese Academy of Medical Sciences | 380 |
Phase 3 Trials
47 Phase 3 registrations this week; the 10 below lead the list.
| NCT | Study | Sponsor | Enrollment | Posted |
|---|---|---|---|---|
| SGB for Prevention of Postop A-Fib After Cardiac SurgeryTrial | The Cleveland Clinic | 60 | ||
| Lean Mass Changes With Semaglutide in Adults With Type 1 Diabetes and Overweight/Obesity. | McGill University Health Centre/Research Institute of the McGill University Health Centre | 40 | ||
| Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis: A Prospective Randomized Controlled Study. | Cairo University | 40 | ||
| Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 226 | ||
| Reducing Arterial Inflammation Using Eplerenone and Statins in HIV | Massachusetts General Hospital | 124 | ||
| A Clinical Study to Evaluate the Effects of Enicepatide Versus Tirzepatide in Participants With Type 2 Diabetes and Inadequate Blood Sugar Control on Oral Glucose-Lowering Medicati | Hoffmann-La Roche | 948 | ||
| Comparing Bispecific Antibody Treatment to Autologous Stem Cell Transplant for Newly Diagnosed, Standard Risk Multiple Myeloma | Alliance for Clinical Trials in Oncology | 920 | ||
| Study of a Combination SARS-CoV-2 Recombinant Spike and High-Dose Inactivated Influenza Vaccine With Matrix-M Adjuvant in Adult Participants 60 Years of Age and Older | Sanofi | 6,000 | ||
| A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis | Pathalys Pharma | 56 | ||
| OLE Study Subsequent to Parent Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC | AVEO Pharmaceuticals, Inc. | 400 |
Phase 4 Trials
29 Phase 4 registrations this week; the 10 below lead the list.
| NCT | Study | Sponsor | Enrollment | Posted |
|---|---|---|---|---|
| Effect of SGLT2 Inhibitor on Metabolic-Dysfunction-Associated Fatty Liver Disease in Patients With Insulin Resistance | Sherihan AboElyazed Mohamed Khalil | 66 | ||
| Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomiz | Bangladesh Medical University | 60 | ||
| Intraperitoneal Hydrocortisone for Postoperative Pain and CRP Following Caesarean Section | Raditsya Mada Gautama, MD | 50 | ||
| Iopidine to Decrease Intraocular Pressure Rise After Injections | Retina Consultants of Delmarva | 120 | ||
| Heated, Humidified High-flow Nasal (HHHFN) Cannula vs Nasal Continuous Positive Airway Pressure in Respiratory Distress in Premature Neonates | Pakistan Air Force (PAF) Hospital Islamabad | 100 | ||
| Intravenous Dexamethasone for ESP Block Analgesia in Children Undergoing Idiopathic Scoliosis Surgery | Poznan University of Medical Sciences | 90 | ||
| Cooling Eyedrops for Dry Eye | University of California, Berkeley | 50 | ||
| This Study is Comparing Pain Outcomes After Urethral Bulking When Participants Are Randomized to Two Different Pain Medication Regimens. | Northwell Health | 46 | ||
| Effect of Low-Dose Esketamine Combined With Dexmedetomidine on the Incidence of Chronic Postsurgical Pain in Patients Undergoing Pancreatic Surgery | Tianjin Medical University Cancer Institute and Hospital | 450 | ||
| Low-Dose Spironolactone in Hemodialysis Patients With Resistant Hypertension | Universitas Sebelas Maret | 21 |
510(k) Clearances
118 510(k) clearances this week; the 10 below lead the list.
| K number | Device | Applicant | Class | Decision |
|---|---|---|---|---|
| Helo Return | Endovascular Engineering, Inc. | 2 | ||
| TruVision Single-Use 1.9mm Arthroscopy System | Nexus CMF, LLC | 2 | ||
| Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler | Medical Components, Inc. | 2 | ||
| Wishbone HAE | Wishbone SA | 2 | ||
| CMF Titanium Splints | Materialise NV | 2 | ||
| Sleep Analysis Module | Neurotronics, LLC | 2 | ||
| VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. | Vivachek Biotech (Hangzhou) Co., Ltd. | 2 | ||
| The D-Tip Denudation Pipette | Allwin Medical Devices, Inc. | 2 | ||
| Excelsior Reach Microcatheter | Stryker Neurovascular | 2 | ||
| Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) | CathRx, Ltd. | 2 |
PMA Approvals
289 PMA decisions this week; the 10 below lead the list.
| PMA | Device | Applicant | Decision |
|---|---|---|---|
| MED-EL Cochlear Implant System | Med-El Corp. | ||
| OrganOx metra® System | Organox Limited | ||
| InterStim Therapy System, Verify Evaluation System | Medtronic Neuromodulation | ||
| Acticor Sky VR-T 481989; Rivacor Sky VR-T 481984; Rivacor Rise VR-T 482020; Rivacor Aura VR-T 482015; Acticor Sky VR-T D | Biotronik, Inc. | ||
| Acticor Sky HF-T 481986; Rivacor Sky HF-T 481991; Rivacor Rise HF-T 482017; Rivacor Aura HF-T 482013; Acticor Sky HF-T Q | Biotronik, Inc. | ||
| Affera Sphere-9 Mapping and Ablation Catheter | Medtronic, Inc. | ||
| Edora 8 HF-T QP 407137; Edora 8 HF-T 407138; Evity 8 HF-T QP 407139; Evity 8 HF-T 407140; Enitra 8 HF-T QP 407141; Enitr | Biotronik, Inc. | ||
| Edora 8 DR-T 407145; Evity 8 DR-T 407146; Enitra 8 DR-T 407147; Enticos 8 DR-T 407148; Evity 6 DR-T 407149; Enitra 6 DR- | Biotronik, Inc. | ||
| Acticor Sky DR-T 481987; Rivacor Sky DR-T 481982; Rivacor Rise DR-T 482018; Rivacor Aura DR-T 482014 | Biotronik, Inc. | ||
| ATTUNE Revision Knee System | Depuy, Inc. |
Recalls
4 recall events this week.
| Firm | Product | Reason | Catalog rows | Posted |
|---|---|---|---|---|
| Greiner Bio-One North America, Inc. | Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 | Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause hyp | 1 | |
| Medtronic MiniMed, Inc. | CareLink Clinic, REF: MMT-7350 | CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily Dose (TDD) or Long-acti | 1 | |
| Beckman Coulter, Inc. | ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), | Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break into multiple pieces during use may result in significant damage to materials (i.e., | 2 | |
| Ventec Life Systems, Inc. | VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support. | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. | 12 |
Drug Safety Reports (FAERS)
352,949 adverse event reports this week; the 10 below lead the list.
| Reaction | Reports |
|---|---|
| Off label use | 19,437 |
| Drug ineffective | 17,826 |
| Nausea | 13,583 |
| Product dose omission issue | 12,230 |
| Diarrhoea | 12,101 |
| Death | 11,969 |
| Fatigue | 11,899 |
| Pruritus | 10,348 |
| Headache | 9,032 |
| Meningioma | 8,392 |
Device Safety Reports (MAUDE)
444,608 device event reports this week; the 10 below lead the list.
| Brand | Manufacturer | Events |
|---|---|---|
| FreeStyle Libre 2 | 48,940 | |
| FreeStyle Libre 3 | 27,036 | |
| Medline | 26,559 | |
| FreeStyle Libre 3 Plus | 20,011 | |
| Dexcom G7 Continuous Glucose Monitoring System | 19,032 | |
| FreeStyle Libre 2 Plus | 16,764 | |
| Inset Guard | 14,188 | |
| t:slim X2 Insulin Pump with Control-IQ Technology | 9,283 | |
| FreeStyle Libre 14 Day | 9,081 | |
| t:slim X2 Insulin Pump with Control-IQ+ Technology | 7,949 |
Device Listings (GUDID)
25,552 device listings this week; the 10 below lead the list.
| Brand | Company | GMDN | Published |
|---|---|---|---|
| Aligned Medical Solutions | Aligned Medical Solutions | General surgical procedure kit, non-medicated, single-use | |
| Aligned Medical Solutions | Aligned Medical Solutions | General surgical procedure kit, non-medicated, single-use | |
| Aligned Medical Solutions | Aligned Medical Solutions | General surgical procedure kit, non-medicated, single-use | |
| Moxi S9-RX | Sonova AG | Air-conduction hearing aid, receiver-in-canal | |
| Aura:fit 5.10 | Sonova AG | Audiometric/hearing device software | |
| Millennium | Avalign Technologies, Inc. | Corneal scissors, reusable | |
| Millennium | Avalign Technologies, Inc. | Hand-held dental retractor | |
| Millennium | Avalign Technologies, Inc. | Orthopaedic joint/limb rongeur | |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | Surgical screwdriver, reusable | |
| Aligned Medical Solutions | Aligned Medical Solutions | Orthopaedic surgical procedure kit, non-medicated, single-use |
Canada (Health Canada MDALL)
161 new device licences this week; the 10 below lead the list.
| Device | Company | Class | Licensed |
|---|---|---|---|
| Nerve Block Tray - Wrhn | Medline Industries, LP | 2 | |
| Epidural Tray Wrhn | Medline Industries, LP | 2 | |
| Cobas Pro Integrated Solutions System Software Version 03-05 | Roche Diagnostics GmbH | 4 | |
| Pressure Injectable Arrowg+Ard Blue Advance One-Lumen Picc | Arrow International LLC Subsidiary of Teleflex Incorporated | 3 | |
| Pressure Injectable Arrowg+Ard Blue Advance Two-Lumen Picc | Arrow International LLC Subsidiary of Teleflex Incorporated | 3 | |
| Tissue Doppler Imaging | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 3 | |
| Ophthalmic Laser Diagnosis Device-Oct | Suzhou Microclear Medical Instrument Co., Ltd. | 2 | |
| Custom Dental Pack | Valuemed Professional Products Ltd. | 2 | |
| Airtouch F40 | Resmed Pty Limited | 2 | |
| Iscape View | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 3 |
Drug Labels
1 label effective dates this week.
| Brand | Generic | Manufacturer | Effective |
|---|---|---|---|
| Colgate Kids Cavity Protection | Sodium Fluoride | Colgate-Palmolive Company |
Workforce (NPPES)
61,063 new provider enumerations this week; the 10 below lead the list.
| State | New providers | Organizations |
|---|---|---|
| CA | 9,336 | 1,293 |
| TX | 4,003 | 1,044 |
| FL | 3,761 | 1,121 |
| NY | 3,353 | 552 |
| MI | 3,076 | 396 |
| IL | 2,610 | 496 |
| OH | 2,509 | 344 |
| NC | 1,716 | 448 |
| PA | 1,667 | 328 |
| CO | 1,603 | 428 |
Industry Payments (Open Payments)
15,384,974 industry payments this week; the 10 below lead the list.
| Payer | Total (USD) | Payments |
|---|---|---|
| BioNTech SE | 180,558,679 | 164 |
| AbbVie Inc. | 156,382,683 | 1,720,745 |
| Stryker Corporation | 132,155,940 | 162,439 |
| Medtronic, Inc. | 117,649,217 | 342,148 |
| Arthrex, Inc. | 104,199,464 | 49,443 |
| Edge Endo LLC | 91,139,127 | 11 |
| Zimmer Biomet Holdings, Inc. | 83,904,351 | 32,760 |
| Intuitive Surgical, Inc. | 72,225,869 | 116,855 |
| Takeda Pharmaceuticals U.S.A., Inc. | 71,616,187 | 171,595 |
| Advanced Accelerator Applications | 63,931,988 | 167 |
Patents (USPTO, A61)
95 medtech patent grants this week; the 10 below lead the list.
| Assignee | Grants |
|---|---|
| Globus Medical, Inc. | 8 |
| Hytto Pte. Ltd. | 2 |
| Medicrea International | 2 |
| Koninklijke Philips N.V. | 2 |
| Warsaw Orthopedic, Inc. | 2 |
| Neodyne Biosciences, Inc. | 1 |
| GlaxoSmithKline Intellectual Property Development Limited | 1 |
| University of Florida Research Foundation, Incorporated | 1 |
| Intuitive Surgical Operations, Inc. | 1 |
| Universitätsspital Basel | 1 |
Literature (PubMed)
105,876 literature records this week; the 10 below lead the list.
| PMID | Title | Journal | Revised |
|---|---|---|---|
| Public Health Benefits 16 Years After a Statewide Policy Change: Communities That Care in Pennsylvania. | Prevention science : the official journal of the Society for Prevention Research | ||
| Factors Associated With Sexual Risk Behaviors Among People Who Use Drugs in Communities in Cambodia. | Asia-Pacific journal of public health | ||
| Structural plasticity of actin-spectrin membrane skeleton and functional role of actin and spectrin in axon degeneration. | eLife | ||
| Exercise Intervention in PTSD: A Narrative Review and Rationale for Implementation. | Frontiers in psychiatry | ||
| Mobility in osteogenesis imperfecta: a multicenter North American study. | Genetics in medicine : official journal of the American College of Medical Genetics | ||
| Targeted degradation of aberrant tau in frontotemporal dementia patient-derived neuronal cell models. | eLife | ||
| The associations of anthropometric, behavioural and sociodemographic factors with circulating concentrations of IGF-I, IGF-II, IGFBP-1, IGFBP-2 and IGFBP-3 in a pooled analysis of 16,024 men from 22 s | International journal of cancer | ||
| Absolute risks of cervical precancer among women who fulfill exiting guidelines based on HPV and cytology cotesting. | International journal of cancer | ||
| Publisher Correction: SERPINB1-mediated checkpoint of inflammatory caspase activation. | Nature immunology | ||
| DEL-1 promotes macrophage efferocytosis and clearance of inflammation. | Nature immunology |
Literature by Subject (MeSH)
225,851 annotated literature records this week; the 10 below lead the list.
| MeSH heading | Articles |
|---|---|
| Humans | 104,472 |
| Male | 59,109 |
| Female | 56,992 |
| Animals | 48,710 |
| Adult | 31,293 |
| Middle Aged | 26,548 |
| Aged | 20,099 |
| Mice | 12,999 |
| Rats | 11,808 |
| Adolescent | 10,189 |
Insider Buying (Form 4)
289 open-market insider purchases this week; the 10 below lead the list.
| Ticker | Owner | Traded | Shares | Value (USD) |
|---|---|---|---|---|
| Lincoln Financial Investments Corp | 2,477,701 | 25,000,000 | ||
| Global X Management Company, Inc. | 1,945,525 | 25,000,000 | ||
| Nippon Life Insurance Co | 510,873 | 17,076,202 | ||
| Nippon Life Insurance Co | 347,195 | 12,052,562 | ||
| Rachlin Evan Lockwood | 718,750 | 11,500,000 | ||
| NONE | MSD Capital, L.P. | 390,857 | 9,568,179 | |
| Nippon Life Insurance Co | 217,182 | 7,684,334 | ||
| Nippon Life Insurance Co | 193,357 | 6,769,545 | ||
| Pale Fire Capital SE | 438,900 | 5,756,876 | ||
| Zhang Jason Gechen | 300,000 | 5,658,000 |
Academica Weekly is assembled and published automatically each week. This issue covers 19 October 2026 to 25 October 2026 and was built on 25 October 2026.