Academica Weekly: The Primary Record for the Week Ending 20 September 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 14 September 2026 to 20 September 2026: 22 recall events; 133 510(k) clearances; 158 new Health Canada device licences; 2,523 ARTG device entries; 469 open-market insider purchases.
22 recall events
133 510(k) clearances
158 new Health Canada device licences
2523 ARTG device entries
133510(k) clearances299PMA decisions22recall events352,949adverse event reports439,212device event reports25,552device listings2,523ARTG device entries158new device licences2label effective dates65,735new provider enumerations15,384,974industry payments95medtech patent grants130,554literature records469open-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 | 17 July 2026 | 65 days behind |
| FDA 510(k) | 6 September 2026 | 14 days behind |
| FDA PMA | 4 September 2026 | Current |
| FDA recalls | 16 September 2026 | Current |
| FDA guidance | 8 September 2026 | 12 days behind |
| FAERS | 30 June 2026 | Current |
| MAUDE | 31 August 2026 | Current |
| GUDID | 26 July 2026 | 56 days behind |
| TGA ARTG | 19 September 2026 | Current |
| Health Canada | 18 September 2026 | Current |
| FDA drug labels | 16 September 2026 | 4 days behind |
| NPPES | 12 September 2026 | Current |
| Open Payments | 31 December 2024 | 628 days behind |
| USPTO | 10 February 2026 | 222 days behind |
| PubMed | 19 September 2026 | Current |
| SEC Form 4 | 18 September 2026 | Current |
510(k) Clearances
133 510(k) clearances this week; the 10 below lead the list.
| K number | Device | Applicant | Class | Decision |
|---|---|---|---|---|
| KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) | Fidelity BioPharma Co. | 2 | ||
| Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST- | Shenzhen Osto Medical Technology Co.,Ltd | 2 | ||
| FreezeSpray TA | Cryosurgery, Inc. | U | ||
| LipoSurg ARTIST | Nouvag AG | 2 | ||
| TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) | Sentinel Medical Technologies, | 2 | ||
| Peerbridge COR MDx (Cor MDx) | Peerbridge Health, Inc. | 2 | ||
| NextMR Spine | MRI2CT, Inc. | 2 | ||
| IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) | Siemens Healthcare Diagnostics Products, Ltd. | 2 | ||
| Digital Indeflator INFLANTE | UAB Telemedicina | 2 | ||
| Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA | Ortho Clinical Diagnostics Inc. (QuidelOrtho) | 2 |
PMA Approvals
299 PMA decisions this week; the 10 below lead the list.
| PMA | Device | Applicant | Decision |
|---|---|---|---|
| N16837 | Artegraft Collagen Vascular Graft | LeMaitre Vascular, Inc. | |
| Ceramax Ceramic Hip System | DePuy Orthopaedics, Inc. | ||
| Supartz Fx | Seikagaku Corp. | ||
| Gel-One | Seikagaku Corp. | ||
| TactiFlex Duo Ablation Catheter, Sensor Enabled (A-TFDM-D, A-TFDM-F, A-TFDM-J, A-TFDM-DD, A-TFDM-DF, A-TFDM-FF, A-TFDM | Abbott Medical | ||
| Guardant360® CDx | Guardant Health, Inc. | ||
| HiResolution Bionic Ear System | Advanced Bionics | ||
| TruSight Oncology Comprehensive | Illumina, Inc. | ||
| FARASTAR Pulsed Field Ablation (PFA) Generator; FARASTAR Mapping System Module (MSM); FARASTAR Recording System Modul | Farapulse, Inc. | ||
| RxSight Light Adjustable Lens and Light Delivery Device | Rxsight, Inc. |
Recalls
22 recall events this week; the 10 below lead the list.
| Firm | Product | Reason | Catalog rows | Posted |
|---|---|---|---|---|
| Medline Industries, LP | Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used. | 4 | |
| Stryker Sustainability Solutions | REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM | Reusable access port system may crack or seperate during use. | 6 | |
| Howmedica Osteonics Corp. | SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene) | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to | 12 | |
| Mirion Technologies (Capintec), Inc. | Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154; | Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground. | 1 | |
| Wilson-Cook Medical Inc. | Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemost | Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU). | 1 | |
| Medical Action Industries, Inc. 306 | Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Collection Kit, REF: 81834C. All containing BD ChloraPrep Clear - 1 mL Applicators | Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the component's sterile barrier and if used may lead to localized skin o | 1 | |
| embecta Medical II LLC | EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100 | Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices. | 2 | |
| AVID Medical, Inc. | Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415; | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. | 4 | |
| Boston Scientific Corporation | Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006 | A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation. | 1 | |
| Abiomed, Inc. | Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, | The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. | 3 |
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 |
|---|---|---|---|
| Moxi S9-RX | Sonova AG | Air-conduction hearing aid, receiver-in-canal | |
| One Step | Zhejiang Orient Gene Biotech Co.,Ltd. | Faecal occult blood IVD, kit, rapid ICT, self-testing | |
| 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 | |
| Aligned Medical Solutions | Aligned Medical Solutions | General surgical procedure kit, non-medicated, single-use | |
| Millennium | Avalign Technologies, Inc. | Orthopaedic joint/limb rongeur | |
| Relate5.0 Platinum RIC RX | Sonova AG | Air-conduction hearing aid, receiver-in-canal | |
| Millennium | Avalign Technologies, Inc. | Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable | |
| Moxi S7-RX | Sonova AG | Air-conduction hearing aid, receiver-in-canal | |
| Moxi S9-RX | Sonova AG | Air-conduction hearing aid, receiver-in-canal |
Australia (TGA ARTG)
2,523 ARTG device entries this week; the 10 below lead the list.
| Brand | Manufacturer | Sponsor | Class | Effective |
|---|---|---|---|---|
| Surgical Drive System | Guangdong JINME Medical Technology Co Ltd | Premium Ventures Pty Ltd | Class IIa | |
| Stella disinfection System | Tristel Solutions Limited | Tristel Pty Ltd | Class IIb | |
| Tristel Trio Wipes System | Tristel Solutions Limited | Tristel Pty Ltd | Class IIb | |
| Gore | WL Gore & Associates Inc | W L Gore & Associates (Australia) Pty Ltd | Class III | |
| Formus Hip | Formus Labs Limited | Formus Labs Australia Pty Ltd | Class IIa | |
| Jet Pro | Tristel Solutions Limited | Tristel Pty Ltd | Class IIb | |
| Dual Stage Venous Drainage Cannula | enableCV LLC | Device Technologies Australia Pty Ltd | Class III | |
| DRY/DUO Wipes | Tristel Solutions Limited | Tristel Pty Ltd | Class 1 | |
| Stella disinfection System | Tristel Solutions Limited | Tristel Pty Ltd | Class IIb | |
| Tristel CLEAN | Tristel Solutions Limited | Tristel Pty Ltd | Class 1 |
Canada (Health Canada MDALL)
158 new device licences this week; the 10 below lead the list.
| Device | Company | Class | Licensed |
|---|---|---|---|
| Contour Embolization Particles | Boston Scientific Corporation | 3 | |
| Electrosurgical Patient Plate: Small Split | 3m Company | 2 | |
| Electrosurgical Patient Plate: Split | 3m Company | 2 | |
| Universal Electrosurgical Pad: Split | 3m Company | 2 | |
| Universal Electrosurgical Pad: Split with Cord | 3m Company | 2 | |
| Valproic Acid | Microgenics Corporation | 2 | |
| Hvad Controller | Heartware, Inc. | 4 | |
| Heartware Controller Dc Adapter | Heartware, Inc. | 4 | |
| Hvad Alarm Adapter | Heartware, Inc. | 4 | |
| Heartware Data Cable | Heartware, Inc. | 4 |
Drug Labels
2 label effective dates this week; the 1 below lead the list.
| Brand | Generic | Manufacturer | Effective |
|---|---|---|---|
| captopril | Captopril | Amici Pharma, Inc. |
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)
130,554 literature records this week; the 10 below lead the list.
| PMID | Title | Journal | Revised |
|---|---|---|---|
| Perceived organizational support and psychological capital in the relationship between job crafting and occupational wellbeing in CSSD nurses: a cross-sectional study. | Frontiers in public health | ||
| SGLT2 versus DPP-4 inhibitors in type 2 diabetes: a meta-analysis of outcomes. | Frontiers in endocrinology | ||
| Development and external validation of an explainable machine learning model for in-hospital mortality risk stratification in intensive care unit patients with heart failure. | Frontiers in cardiovascular medicine | ||
| Controlled breathing is associated with lower blood lactate than normobaric hypoxia despite comparable peripheral oxygen saturation during moderate-intensity exercise: an exploratory crossover study. | Frontiers in physiology | ||
| Effects of recumbency and tube current on image quality of canine elbow computed tomography. | Frontiers in veterinary science | ||
| Comparing the efficacy of first-line immunotherapies in autoimmune encephalitis: a scoping review. | Frontiers in neurology | ||
| Development and validation of a population-based prediction model for prevalent hypertension: evidence from Qatar biobank. | Frontiers in cardiovascular medicine | ||
| Vertebral artery pseudoaneurysm with recurrent posterior circulation transient ischemic attacks in a post-radiotherapy nasopharyngeal carcinoma survivor: a case report. | Frontiers in oncology | ||
| A novel, non-invasive approach to esophageal coin removal in a child using oral olive oil: case report. | Frontiers in pediatrics | ||
| Machine learning-based risk prediction model for postoperative abdominal distension after spinal surgery under general anesthesia. | Frontiers in medicine |
Literature by Subject (MeSH)
223,241 annotated literature records this week; the 10 below lead the list.
| MeSH heading | Articles |
|---|---|
| Humans | 100,279 |
| Female | 59,264 |
| Male | 55,422 |
| Middle Aged | 32,325 |
| Adult | 31,663 |
| Animals | 29,342 |
| Aged | 24,091 |
| Young Adult | 12,098 |
| Retrospective Studies | 11,453 |
| Mice | 11,414 |
Insider Buying (Form 4)
469 open-market insider purchases this week; the 10 below lead the list.
| Ticker | Owner | Traded | Shares | Value (USD) |
|---|---|---|---|---|
| Cascade Investment, L.l.c. | 324,810 | 72,396,344 | ||
| Cascade Investment, L.l.c. | 256,000 | 56,909,273 | ||
| Wilks Matthew | 1,319,493 | 34,320,013 | ||
| Hrt Financial LP | 101,212 | 15,993,769 | ||
| Tricor PMT25 Holdings Inc. | 525,000 | 11,287,500 | ||
| Nippon Life Insurance Co | 320,785 | 11,232,960 | ||
| Nippon Life Insurance Co | 295,967 | 10,318,653 | ||
| Murdoch Lachlan K | 149,934 | 10,274,977 | ||
| NONE | LIBERTY MUTUAL HOLDING Co INC. | 398,774 | 9,761,988 | |
| NONE | Bankers Life & Casualty Co | 785,083 | 8,000,000 |
Academica Weekly is assembled and published automatically each week. This issue covers 14 September 2026 to 20 September 2026 and was built on 20 September 2026.