Academica Weekly: The Primary Record for the Week Ending 11 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 5 October 2026 to 11 October 2026: 38 Phase 3 trial registrations; 89 Phase 2 trial registrations; 12 recall events; 160 510(k) clearances; 380 open-market insider purchases.
38 Phase 3 trial registrations
89 Phase 2 trial registrations
12 recall events
160 510(k) clearances
58Phase 1 registrations89Phase 2 registrations38Phase 3 registrations37Phase 4 registrations160510(k) clearances269PMA decisions12recall events352,949adverse event reports439,212device event reports25,552device listings1label effective dates65,735new provider enumerations15,384,974industry payments95medtech patent grants532,501literature records380open-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 | 9 October 2026 | Current |
| FDA 510(k) | 27 September 2026 | 14 days behind |
| FDA PMA | 25 September 2026 | Current |
| FDA recalls | 7 October 2026 | Current |
| FDA guidance | 1 October 2026 | 10 days behind |
| FAERS | 30 June 2026 | Current |
| MAUDE | 31 August 2026 | Current |
| GUDID | 26 July 2026 | 77 days behind |
| TGA ARTG | 2 October 2026 | 9 days behind |
| Health Canada | 2 October 2026 | 9 days behind |
| FDA drug labels | 6 October 2026 | 5 days behind |
| NPPES | 12 September 2026 | Current |
| Open Payments | 31 December 2024 | 649 days behind |
| USPTO | 10 February 2026 | 243 days behind |
| PubMed | 10 October 2026 | Current |
| SEC Form 4 | 9 October 2026 | Current |
Phase 1 Trials
58 Phase 1 registrations this week; the 10 below lead the list.
| NCT | Study | Sponsor | Enrollment | Posted |
|---|---|---|---|---|
| A Study of Single and Multiple Doses of LY5625573 in Healthy Participants, Including Japanese and Chinese Populations, and Participants With Inflammation (High C-Reactive Protein) | Eli Lilly and Company | 96 | ||
| A Phase I Study to Investigate KH-001 in Healthy Males | Kadence Bio | 82 | ||
| Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose | Vertex Pharmaceuticals Incorporated | 8 | ||
| A Phase I, Randomized, Double-Blind, Placebo-Controlled Study of EQ504 in Single and Multiple Ascending Doses in Healthy Volunteers | Equillium | 70 | ||
| 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 Tirzep | Novo Nordisk A/S | 60 | ||
| A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ATI-105 in Healthy Adults | Adjuvia Therapeutics, Inc. | 60 | ||
| A Study to Investigate the Effects of Moderate or Severe Renal Impairment (RI) on Velzatinib | GlaxoSmithKline | 30 | ||
| GST101 in Participants With RAS-Mutant Advanced Solid Tumors | Genuine Seed Therapeutics (Zhuhai) Co., Ltd. | 172 | ||
| A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positiv | Genentech, Inc. | 165 | ||
| A Study of LY4515100 in Healthy Male Participants | Eli Lilly and Company | 16 |
Phase 2 Trials
89 Phase 2 registrations this week; the 10 below lead the list.
| NCT | Study | Sponsor | Enrollment | Posted |
|---|---|---|---|---|
| Study of ORJ-001 for the Treatment of IPF | Oorja Bio, Inc. | 95 | ||
| Novel and Conventional Interventions for Cognitive and Emotional Flexibility in Patient Trauma | Mclean Hospital | 75 | ||
| (Z)-Endoxifen in Girls With MAS-Associated Peripheral Precocious Puberty | Atossa Therapeutics, Inc. | 6 | ||
| A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of NIO752 in Primary Tauopathies | Novartis Pharmaceuticals | 48 | ||
| Randomised Controlled Trial Comparing CD62L and CD45RA Depleted Donor Lymphocyte Infusion With T-cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation | Hong Kong Children's Hospital | 46 | ||
| Memantine Targeting Neurovascular Dysfunction After Mild and Moderate Traumatic Brain Injury (MEND) | Nova Scotia Health Authority | 45 | ||
| Phase II De-Escalation Study of Metronomic Decitabine/Cedazuridine Plus Venetoclax in AML | Rutgers, The State University of New Jersey | 41 | ||
| Peer Support for Family Caregivers of Older Adults Living With Dementia | Ohio State University | 344 | ||
| Post-traumatic Estradiol Administration and Care Evaluation (PEACE) | University of North Carolina, Chapel Hill | 30 | ||
| Neoadjuvant Iparomlimab and Tuvonralimab With Nab-P-SOX in Locally Advanced Gastric or Gastroesophageal Junction Cancer | Ruijin Hospital | 28 |
Phase 3 Trials
38 Phase 3 registrations this week; the 10 below lead the list.
| NCT | Study | Sponsor | Enrollment | Posted |
|---|---|---|---|---|
| A Multicenter, Randomized, Controlled Phase III Clinical Trial on Adjuvant Intensified Therapy for Patients With Residual Disease After Neoadjuvant Treatment for Triple-negative Br | Shandong Cancer Hospital and Institute | 852 | ||
| Oral VK2735 for Weight Management in Adults With Type 2 Diabetes Mellitus Phase 3 (SUNRISE 2) | Viking Therapeutics, Inc. | 560 | ||
| Oral VK2735 for Weight Management Phase 3 (SUNRISE 1) | Viking Therapeutics, Inc. | 560 | ||
| Phase 3 Study of Intravitreal 4D-150 in Adults With Diabetic Macular Edema (DME) (4D-150-C005) | 4D Molecular Therapeutics | 514 | ||
| A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants. | FrieslandCampina | 387 | ||
| "Evaluation of the Efficacy of Intravenous Lidocaine on Chronic Post-operative Pain in Patients Requiring Emergency Abdominal Surgery. A Multicentre, Randomised, Controlled, Double | Nantes University Hospital | 266 | ||
| Surgery Versus Stereotactic Ablative Radiotherapy for Patients With Locally Advanced Pancreatic Cancer With Favourable Biological Response Following Induction Chemotherapy | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | 230 | ||
| Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine (NAL) Extended-Release (ER) Tablets | Trevi Therapeutics | 201 | ||
| Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis | McMaster Children's Hospital | 180 | ||
| IMPT Versus IMRT for Diffuse Intrinsic Pontine Glioma | Shandong Cancer Hospital and Institute | 142 |
Phase 4 Trials
37 Phase 4 registrations this week; the 10 below lead the list.
| NCT | Study | Sponsor | Enrollment | Posted |
|---|---|---|---|---|
| The Safety of Simplified Tranexamic Acid Regimen | Second Affiliated Hospital, Zhejiang University, School of Medicine | 60 | ||
| Evaluation of Ophtholic Ultra for Ocular Surface Protection After Cataract Surgery | Kazakh Eye Research Institute | 60 | ||
| Botulinum Toxin Type A Versus Triamcinolone for Facial Myalgia | Riyadh Elm University | 56 | ||
| Articaine Versus Lidocaine for Supplemental Buccal Infiltration in Lower First Molars With Irreversible Pulpitis | Rehman Medical Institute - RMI | 50 | ||
| Community Active and Healthy Families Pragmatic Trial | University of Colorado, Denver | 416 | ||
| Fractional CO₂ Laser Combined With Topical Plant-Derived Exosomes Versus Non-Cross-Linked Hyaluronic Acid for Atrophic Acne Scars | October 6 University | 30 | ||
| Randomized, Controlled Study to Investigate the 12-month Efficacy and Safety of Resveratrol Vitamin Supplements in Patients With Non-proliferative Diabetic Retinopathy Without Cent | University of Athens | 100 | ||
| Effect of Labetalol, Magnesium Sulfate, or Lidocaine on Opioid Consumption During Laparoscopic Cholecystectomy | Assiut University | 90 | ||
| Oral Nifedipine vs Vaginal Progesterone for Prolonging Pregnancy in Preterm Labor | Medicare Hospital (Pvt) Limited | 84 | ||
| Combination of Pregabalin and Trigger Point Injection With Ropivacaine in the Treatment of Myofascial Pain Syndrome of the Neck and Upper Back. | National and Kapodistrian University of Athens | 74 |
510(k) Clearances
160 510(k) clearances this week; the 10 below lead the list.
| K number | Device | Applicant | Class | Decision |
|---|---|---|---|---|
| Kentrospine Viktr-MIS® Pedicle screw system | Rivarp Medical Pvt., Ltd. | 2 | ||
| Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Sh | Fit-Pro KFT (Ltd.) - DBA E-Fit | |||
| DistaSense(TM) (v1) | Life Detection Technologies | 2 | ||
| Rebohil (Bgm-1, Bgm-2, Bgm-3, Bgm-4, Bgm-5) | Hyundai Bioland Co., Ltd. | 2 | ||
| CapsoView (CVV); CapsoCloud (CLD) | CapsoVision, Inc. | 2 | ||
| UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade | Karl Storz SE & CO. KG | 2 | ||
| S-Patch CardioAI | Wellysis Corp. | 2 | ||
| easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use | Ezisurg Medical Co., Ltd. | 2 | ||
| Tempus ECG-MR | Tempus AI, Inc. | 2 | ||
| TumorSight Risk | SimBioSys, Inc. | 2 |
PMA Approvals
269 PMA decisions this week; the 10 below lead the list.
| PMA | Device | Applicant | Decision |
|---|---|---|---|
| Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T, Acticor 7 DR-T, Rivacor 7 DR-T, Rivacor 5 DR-T | Biotronik, Inc. | ||
| Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7 VR-T 404634; I | Biotronik, Inc. | ||
| Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | ||
| Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 | Biotronik, Inc. | ||
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D | Medtronic Cardiac Rhythm Disease Management | ||
| 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 Enitra 8 H | Biotronik, Inc. | ||
| Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky VR-T DX, Riva | Biotronik, Inc. | ||
| LCS® Total Knee System | Depuy, Inc. | ||
| AeroPace® System | Lungpacer Medical USA, Inc. | ||
| Liverty TIPS Stent Graft | Bard Peripheral Vascular, Inc. |
Recalls
12 recall events this week; the 10 below lead the list.
| Firm | Product | Reason | Catalog rows | Posted |
|---|---|---|---|---|
| Mindray DS USA, Inc. | BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80 | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions | 8 | |
| Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC | SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000; | During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of bloo | 1 | |
| LeMaitre Vascular, Inc. | TufTex Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88; | Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. | 1 | |
| Intellijoint Surgical, Inc. | Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249 | A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire saf | 1 | |
| AVID Medical, Inc. | PLASTICS TRAY; Model/Item Number (Kit): EURO053; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | 15 | |
| Steris Corporation | HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18 | A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical im | 1 | |
| Canon Medical System, USA, INC. | Alphenix INFX-8000C/B5 | Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error | 1 | |
| Nihon Kohden America LLC | Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40 Product Desc | Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms. | 1 | |
| Onkos Surgical, Inc. | Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M | Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. | 2 | |
| Stryker Sustainability Solutions | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6F, Large 4.0, 10, 2-5-2Mm, Ref: 201007 | Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate | 1 |
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)
439,212 device event reports this week; the 10 below lead the list.
| Brand | Manufacturer | Events |
|---|---|---|
| FreeStyle Libre 2 | 47,720 | |
| FreeStyle Libre 3 | 26,371 | |
| FreeStyle Libre 3 Plus | 22,199 | |
| Dexcom G7 Continuous Glucose Monitoring System | 21,690 | |
| FreeStyle Libre 2 Plus | 18,829 | |
| Medline | 16,603 | |
| Inset Guard | 16,392 | |
| FreeStyle Libre 14 Day | 9,474 | |
| t:slim X2 Insulin Pump with Control-IQ Technology | 9,380 | |
| t:slim X2 Insulin Pump with Control-IQ+ Technology | 7,573 |
Device Listings (GUDID)
25,552 device listings this week; the 10 below lead the list.
| Brand | Company | GMDN | Published |
|---|---|---|---|
| Relate5.0 Platinum RIC RX | Sonova AG | Air-conduction hearing aid, receiver-in-canal | |
| Velora RED | Omm Imports Inc. | Blue/red/infrared phototherapy lamp | |
| Relate5.0 Gold RIC RX | Sonova AG | Air-conduction hearing aid, receiver-in-canal | |
| Relate5.0 Gold RIC RX | Sonova AG | Air-conduction hearing aid, receiver-in-canal | |
| Millennium | Avalign Technologies, Inc. | General-purpose surgical scissors, reusable | |
| Aligned Medical Solutions | Aligned Medical Solutions | General surgical procedure kit, non-medicated, single-use | |
| Aligned Medical Solutions | Aligned Medical Solutions | Neurosurgical procedure kit, non-medicated, single-use | |
| Moxi S7-RX | Sonova AG | Air-conduction hearing aid, receiver-in-canal | |
| Aligned Medical Solutions | Aligned Medical Solutions | General surgical procedure kit, non-medicated, single-use | |
| Unitron ChargerGo RIC S-RX | Sonova AG | Noninvasive device battery charger |
Workforce (NPPES)
65,735 new provider enumerations this week; the 10 below lead the list.
| State | New providers | Organizations |
|---|---|---|
| CA | 10,367 | 1,218 |
| TX | 4,434 | 1,065 |
| FL | 4,273 | 1,243 |
| NY | 3,557 | 566 |
| MI | 2,928 | 406 |
| OH | 2,899 | 280 |
| IL | 1,959 | 466 |
| NC | 1,780 | 453 |
| PA | 1,777 | 373 |
| MD | 1,742 | 295 |
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)
532,501 literature records this week; the 10 below lead the list.
| PMID | Title | Journal | Revised |
|---|---|---|---|
| [Sweet syndrome in chronic myeloid leukemia]. | Klinische Wochenschrift | ||
| Energy deficiency, calcium overload or oxidative stress: possible causes of irreversible ischemic myocardial injury. | Klinische Wochenschrift | ||
| The general rules for the clinical and pathological study of primary liver cancer. Liver Cancer Study Group of Japan. | The Japanese journal of surgery | ||
| In situ localization of transthyretin-mRNA in the adult human liver, choroid plexus and pancreatic islets and in endocrine tumours of the pancreas and gut. | Histochemistry | ||
| Hepatic hemangioma in the presence of fatty infiltration: an atypical sonographic appearance. | Gastrointestinal radiology | ||
| Bone allografts in reconstructive middle ear surgery. | Archives of oto-rhino-laryngology | ||
| The differential diagnosis of nasal mucosal swelling and adenoidal hyperplasia using two- and three-parameter discriminant functions. | Archives of oto-rhino-laryngology | ||
| Renal autotransplantation. | World journal of surgery | ||
| Emergency colonoscopy. | World journal of surgery | ||
| Biliary concrements: the endoscopic approach. | World journal of surgery |
Literature by Subject (MeSH)
1,059,468 annotated literature records this week; the 10 below lead the list.
| MeSH heading | Articles |
|---|---|
| Humans | 674,136 |
| Male | 295,437 |
| Female | 291,579 |
| Animals | 220,581 |
| Adult | 156,613 |
| Middle Aged | 149,513 |
| Aged | 113,323 |
| Retrospective Studies | 93,931 |
| Child | 64,859 |
| Mice | 61,342 |
Insider Buying (Form 4)
380 open-market insider purchases this week; the 10 below lead the list.
| Ticker | Owner | Traded | Shares | Value (USD) |
|---|---|---|---|---|
| Berkshire Hathaway Inc. | 1,708,095 | 135,689,427 | ||
| Berkshire Hathaway Inc. | 710,542 | 56,945,006 | ||
| NONE | Goldentree Asset Management LP | 463,000 | 42,133,000 | |
| Yin Chung-Yao | 14,158,991 | 35,114,298 | ||
| Alvarez Denise Aguiar | 1,950,000 | 33,581,299 | ||
| Alvarez Rubens Aguiar | 1,845,000 | 32,042,484 | ||
| Nippon Life Insurance Co | 606,912 | 20,880,079 | ||
| Huang Jack Jiajia | 1,227,600 | 14,117,400 | ||
| Huang Jack Jiajia | 897,300 | 10,318,950 | ||
| Nippon Life Insurance Co | 272,208 | 9,002,473 |
Academica Weekly is assembled and published automatically each week. This issue covers 5 October 2026 to 11 October 2026 and was built on 11 October 2026.