Academica Weekly: The Primary Record for the Week Ending 30 August 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 24 August 2026 to 30 August 2026: 10 recall events; 119 510(k) clearances; 171 new Health Canada device licences; 2,899 ARTG device entries; 460 open-market insider purchases.
10 recall events
119 510(k) clearances
171 new Health Canada device licences
2899 ARTG device entries
119510(k) clearances308PMA decisions10recall events352,949adverse event reports355,195device event reports27,811device listings2,899ARTG device entries171new device licences367label effective dates62,691new provider enumerations15,384,974industry payments95medtech patent grants117,434literature records460open-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 | 21 August 2026 | 9 days behind |
| FDA 510(k) | 16 August 2026 | 14 days behind |
| FDA PMA | 14 August 2026 | Current |
| FDA recalls | 26 August 2026 | Current |
| FDA guidance | 21 August 2026 | Current |
| FAERS | 30 June 2026 | Current |
| MAUDE | 31 July 2026 | Current |
| GUDID | 22 April 2026 | 130 days behind |
| TGA ARTG | 28 August 2026 | Current |
| Health Canada | 28 August 2026 | Current |
| FDA drug labels | 28 August 2026 | Current |
| NPPES | 8 August 2026 | Current |
| Open Payments | 31 December 2024 | 607 days behind |
| USPTO | 10 February 2026 | 201 days behind |
| PubMed | 29 August 2026 | Current |
| SEC Form 4 | 28 August 2026 | Current |
510(k) Clearances
119 510(k) clearances this week; the 10 below lead the list.
| K number | Device | Applicant | Class | Decision |
|---|---|---|---|---|
| CN-Suite | FIND Surgical Sciences Inc. D/B/A FIND Neuro | 2 | ||
| BAGUERA® C Cervical Disc Surgical Instruments | Spineart SA | 2 | ||
| Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | 2 | ||
| Portable Oxygen Concentrator (PO1 5B, PO1 6B) | BMC Medical Co., Ltd. | 2 | ||
| Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal | Empatica S.r.l. | 2 | ||
| Vital Signs Monitor (CLEO2) | Infinium Medical, Inc. | 2 | ||
| NHanceIT | IMDS Operation B.V. | 2 | ||
| medilogFD | Schiller AG | 2 | ||
| Transpara (2.1.0) | Screenpoint Medical B.V. | 2 | ||
| QuickVision Ultimate rTMS | Brain Ultimate, Inc. | 2 |
PMA Approvals
308 PMA decisions this week; the 10 below lead the list.
| PMA | Device | Applicant | Decision |
|---|---|---|---|
| Altaviva | Medtronic Neuromodulation | ||
| BD Onclarity HPV Assay | Becton, Dickinson and Company | ||
| InterStim Therapy System, Verify Evaluation System | Medtronic Neuromodulation | ||
| ELCA Coronary Laser Atherectomy Catheters | Spectranetics Corp. | ||
| Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces-Quad, Spe | Medtronic Neuromodulation | ||
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense | Medtronic, Inc. | ||
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular | ||
| TruSight Oncology Comprehensive | Illumina, Inc. | ||
| InterStim Therapy System, Verify Evaluation System | Medtronic Neuromodulation | ||
| Titan Inflatable Penile Prosthesis | Coloplast Corp. |
Recalls
10 recall events this week.
| Firm | Product | Reason | Catalog rows | Posted |
|---|---|---|---|---|
| Medline Industries, LP | Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B | Kits contain a potentially contaminated component which were recalled by the manufacturer | 11 | |
| ConMed Corporation | CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile | Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability. | 1 | |
| IMRIS Imaging Inc | ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000 | The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rota | 2 | |
| Fresenius Medical Care Renal Therapies Group, LLC | Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130. | Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T BlueStar Hemodialysis machines. | 1 | |
| FUJIFILM Healthcare Americas Corporation | FUJIFILM Synapse PACS software v7.4.310; radiological image processing system | Software issue may cause the ruler measurement to be inaccurate. | 1 | |
| Olympus Corporation of the Americas | POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories | Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. | 1 | |
| Healthmark Industries Co., Inc. | healthmark ProChek-II, Model Number PT-313, PT-201-12 | Test manufactured with an expired ingredient which may present as either a false negative or positive. | 2 | |
| Midmark Corporation | Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18. | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. | 2 | |
| Henry Schein Inc. | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145 2) 949-3595, Mfr Product Code 1841; Lots 253 | Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. | 2 | |
| Canon Medical System, USA, INC. | Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicat | Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. | 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)
355,195 device event reports this week; the 10 below lead the list.
| Brand | Manufacturer | Events |
|---|---|---|
| Dexcom G7 Continuous Glucose Monitoring System | 13,717 | |
| FreeStyle Libre 3 Plus | 8,265 | |
| DreamStation Auto CPAP | 7,723 | |
| Dexcom G7 Continuous Glucose Monitoring System | 7,464 | |
| Inset Guard | 7,305 | |
| t:slim X2 Insulin Pump with Control-IQ Technology | 6,979 | |
| CareLink SmartSync Common App iOS | 6,253 | |
| FreeStyle Libre 2 Plus | 5,852 | |
| Medline | 5,349 | |
| FreeStyle Libre 2 | 4,525 |
Device Listings (GUDID)
27,811 device listings this week; the 10 below lead the list.
| Brand | Company | GMDN | Published |
|---|---|---|---|
| IH 25° Anatomic Abutment | Surcam - Medical Devices and Developments Ltd. | Dental implant system | |
| I-FIX Angled Mount Adapter Screw | Dentis Co. ,ltd | Dental implant suprastructure, temporary, preformed, single-use | |
| TrellOss®-MCP | Nexxt Spine, LLC | General internal orthopaedic fixation system implantation kit | |
| TrellOss®-MCP | Nexxt Spine, LLC | Device sterilization/disinfection container, reusable | |
| s-Clean Link Abutment ScanPost | Dentis Co. ,ltd | Dental implant suprastructure, temporary, preformed, single-use | |
| TrellOss®-MCP | Nexxt Spine, LLC | Spinal fixation plate, non-bioabsorbable | |
| QUASAR Standalone ACIF System | GS Medical Co., Ltd. | Metallic spinal interbody fusion cage | |
| Anyplus Peek Cage System | GS Medical Co., Ltd. | Polymeric spinal interbody fusion cage | |
| TrellOss®-MCP | Nexxt Spine, LLC | Spinal fixation plate, non-bioabsorbable | |
| Anyplus Peek Cage System | GS Medical Co., Ltd. | Polymeric spinal interbody fusion cage |
Australia (TGA ARTG)
2,899 ARTG device entries this week; the 10 below lead the list.
| Brand | Manufacturer | Sponsor | Class | Effective |
|---|---|---|---|---|
| RayOne Galaxy Hydrophobic | Rayner Intraocular Lenses Ltd | Kevin Grundy (IBD) Pty Ltd | Class IIb | |
| Penumbra Ruby Coil | Penumbra Inc | Penumbra Neuro Australia Pty Ltd | Class III | |
| Penumbra Ruby Coil | Penumbra Inc | Penumbra Neuro Australia Pty Ltd | Class III | |
| Penumbra Ruby Coil | Penumbra Inc | Penumbra Neuro Australia Pty Ltd | Class III | |
| Penumbra Ruby Coil | Penumbra Inc | Penumbra Neuro Australia Pty Ltd | Class III | |
| POD Packing Coil | Penumbra Inc | Penumbra Neuro Australia Pty Ltd | Class III | |
| Penumbra Ruby Coil | Penumbra Inc | Penumbra Neuro Australia Pty Ltd | Class III | |
| Penumbra Ruby Coil | Penumbra Inc | Penumbra Neuro Australia Pty Ltd | Class III | |
| Penumbra Ruby Coil | Penumbra Inc | Penumbra Neuro Australia Pty Ltd | Class III | |
| Penumbra Ruby Coil | Penumbra Inc | Penumbra Neuro Australia Pty Ltd | Class III |
Canada (Health Canada MDALL)
171 new device licences this week; the 10 below lead the list.
| Device | Company | Class | Licensed |
|---|---|---|---|
| Optistar Elite Mr Contrast Delivery System Rolling Stand | Liebel-Flarsheim Company LLC | 2 | |
| Optistar Elite Mr Contrast Delivery System Ceiling Suspension | Liebel-Flarsheim Company LLC | 2 | |
| Optistar Elite Mr Contrast Delivery System Mobile Mount | Liebel-Flarsheim Company LLC | 2 | |
| Precice Locking Screw | Nuvasive Specialized Orthopedics (Globus Medical, Inc.) | 3 | |
| Straumann SGL80M | Nakanishi Inc. | 2 | |
| External Remote Controller | Nuvasive Specialized Orthopedics (Globus Medical, Inc.) | 3 | |
| Precice Antegrade Femur Nail, Pf, Ti | Nuvasive Specialized Orthopedics (Globus Medical, Inc.) | 3 | |
| Precice Antegrade Femur Nail, Gt, Ti | Nuvasive Specialized Orthopedics (Globus Medical, Inc.) | 3 | |
| Precice Antegrade Tibia Nail, Ti | Nuvasive Specialized Orthopedics (Globus Medical, Inc.) | 3 | |
| Ao Drill Bit | Nuvasive Specialized Orthopedics (Globus Medical, Inc.) | 3 |
Drug Labels
367 label effective dates this week; the 10 below lead the list.
| Brand | Generic | Manufacturer | Effective |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Lisdexamfetamine | Amneal Pharmaceuticals LLC | |
| Fingolimod | Fingolimod | Novadoz Pharmaceuticals LLC | |
| Clobetasol Propionate | Clobetasol Propionate Ointment Usp, 0.05% | Bryant Ranch Prepack | |
| Enalapril Maleate | Enalapril Maleate | Coupler LLC | |
| Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | RemedyRepack Inc. | |
| Ibandronate Sodium | Ibandronate Sodium | Bionpharma Inc. | |
| Scentsational Square Hand Sanitizer | Hand Sanitizer | Raining Rose, Inc. | |
| Ciprofloxacin Hydrochloride | Ciprofloxacin Hydrochloride | PD-Rx Pharmaceuticals, Inc. | |
| Dofetilide | Dofetilide | RemedyRepack Inc. | |
| zicam cold and flu-like symptoms Echinacea plus Sambucus | Zinc Acetate Anhydrous, Zinc Gluconate, Echinacea Angustifolia Whole, and Sambucus Nigra Flowering Top | Church & Dwight Co., Inc. |
Workforce (NPPES)
62,691 new provider enumerations this week; the 10 below lead the list.
| State | New providers | Organizations |
|---|---|---|
| CA | 9,060 | 1,212 |
| TX | 4,315 | 1,147 |
| FL | 3,967 | 1,177 |
| NY | 3,408 | 536 |
| MI | 2,694 | 436 |
| OH | 2,519 | 393 |
| MD | 2,206 | 401 |
| NC | 1,976 | 456 |
| IL | 1,824 | 382 |
| PA | 1,688 | 337 |
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)
117,434 literature records this week; the 10 below lead the list.
| PMID | Title | Journal | Revised |
|---|---|---|---|
| Placebo Analgesia Does Not Generalize From Pain to Interoceptive Abilities: A Preregistered Exploratory Study. | Psychophysiology | ||
| Invasive candidiasis in the Intensive Care unit: diagnostic stewardship, source control, and precision antifungal therapy. | Expert review of anti-infective therapy | ||
| Microplastics in bottled water and human health outcomes: a systematic review of multi-organ toxicity and mechanistic pathways. | Journal of environmental science and health. Part C, Toxicology and carcinogenesis | ||
| The Molecular Architecture of Somatic Spines of the Lateral Septum. | The Journal of comparative neurology | ||
| Tribo-electric separation of cereal proteins: machine design, operating parameters, and particle charging on protein separation efficiency and quality. | Critical reviews in food science and nutrition | ||
| Approximately 30% of Patients Undergoing Knee Cartilage Biopsy Subsequently Undergo Matrix-Induced Autologous Chondrocyte Implantation at a Mean 4.3-Year Follow-Up. | Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association | ||
| Vertical Transmission of Zika Virus: The Immune-Pathophysiological Interface of the Placenta. | Journal of immunology research | ||
| The design and optimization of a chitosan-based lamotrigine-loaded intranasal mucoadhesive nanomicelle solution using response surface methodology and artificial neural networks. | Pharmaceutical development and technology | ||
| Machine learning-integrated explainable artificial intelligence for survival prediction in urothelial carcinoma with enfortumab vedotin: an exploratory real-world analysis. | Expert opinion on biological therapy | ||
| Postoperative Pericardial Cyst Enlargement After Recurrent Breast Cancer: Distinguishing Benign vs Malignant Etiologies. | JACC. Case reports |
Literature by Subject (MeSH)
201,410 annotated literature records this week; the 10 below lead the list.
| MeSH heading | Articles |
|---|---|
| Humans | 93,352 |
| Female | 54,497 |
| Male | 49,200 |
| Middle Aged | 29,533 |
| Adult | 28,062 |
| Animals | 25,196 |
| Aged | 22,054 |
| Young Adult | 10,064 |
| Retrospective Studies | 9,755 |
| Mice | 9,470 |
Insider Buying (Form 4)
460 open-market insider purchases this week; the 10 below lead the list.
| Ticker | Owner | Traded | Shares | Value (USD) |
|---|---|---|---|---|
| Bertarelli Ernesto | 8,770,524 | 218,999,984 | ||
| Sitra J Scott | 1,000 | 100,000,000 | ||
| Cascade Investment, L.l.c. | 301,639 | 67,238,851 | ||
| Cascade Investment, L.l.c. | 284,600 | 62,475,598 | ||
| Cascade Investment, L.l.c. | 275,500 | 61,036,215 | ||
| Cascade Investment, L.l.c. | 269,477 | 59,791,492 | ||
| Cascade Investment, L.l.c. | 208,925 | 46,018,127 | ||
| Cascade Investment, L.l.c. | 191,361 | 42,164,922 | ||
| MetLife Investment Management, LLC | 880,000 | 22,000,000 | ||
| NONE | Host-Plus Pty Ltd as trustee for the HOSTPLUS Pooled Superannuation Trust | 7,700,119 | 20,790,321 |
Academica Weekly is assembled and published automatically each week. This issue covers 24 August 2026 to 30 August 2026 and was built on 30 August 2026.