Academica Weekly: The Primary Record for the Week Ending 27 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 21 September 2026 to 27 September 2026: 11 recall events; 140 510(k) clearances; 234 new Health Canada device licences; 2,651 ARTG device entries; 365 open-market insider purchases.
11 recall events
140 510(k) clearances
234 new Health Canada device licences
2651 ARTG device entries
140510(k) clearances256PMA decisions11recall events352,949adverse event reports439,212device event reports25,552device listings2,651ARTG device entries234new device licences5label effective dates65,735new provider enumerations15,384,974industry payments95medtech patent grants269,229literature records365open-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 | 11 September 2026 | 16 days behind |
| FDA 510(k) | 13 September 2026 | 14 days behind |
| FDA PMA | 13 September 2026 | Current |
| FDA recalls | 23 September 2026 | Current |
| FDA guidance | 18 September 2026 | Current |
| FAERS | 30 June 2026 | Current |
| MAUDE | 31 August 2026 | Current |
| GUDID | 26 July 2026 | 63 days behind |
| TGA ARTG | 26 September 2026 | Current |
| Health Canada | 25 September 2026 | Current |
| FDA drug labels | 22 September 2026 | 5 days behind |
| NPPES | 12 September 2026 | Current |
| Open Payments | 31 December 2024 | 635 days behind |
| USPTO | 10 February 2026 | 229 days behind |
| PubMed | 26 September 2026 | Current |
| SEC Form 4 | 25 September 2026 | Current |
510(k) Clearances
140 510(k) clearances this week; the 10 below lead the list.
| K number | Device | Applicant | Class | Decision |
|---|---|---|---|---|
| Safety lancet (XL) | Tianjin Huahong Technology Co., Ltd. | 2 | ||
| Caddie | Odin Medical Limited | 2 | ||
| Digistat Care | Ascom Ums Srl Unipersonale | 2 | ||
| CraniUS Plate | CraniUS, LLC | 2 | ||
| Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tub | Vitaltec Corporation | 2 | ||
| SkinSmart Antimicrobial HydroGel | Magic Science Supply, LLC | U | ||
| Extroducer Infusion Catheter System | SmartWise Sweden AB | 2 | ||
| BoneVue | Curvebeam AI / Curvebeam, LLC | 2 | ||
| Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203) | Shenzhen Xinyan Medical Technology Co.,ltd. | 2 | ||
| Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | 2 |
PMA Approvals
256 PMA decisions this week; the 10 below lead the list.
| PMA | Device | Applicant | Decision |
|---|---|---|---|
| Vercise Deep Brain Stimulation (Dbs) System | Boston Scientific Corp | ||
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) Charger | Abbott Medical | ||
| CardioMEMS PA Sensor and Delivery System (CM2000); CardioMEMS HF System | Abbott Medical | ||
| MMR IHC Panel pharmDx (Dako Omnis) | Agilent Technologies, Inc. | ||
| Shockwave Intravascular Lithotripsy (Ivl) System with Shockwave C2/C2+ Coronary Ivl Catheter | Shockwave Medical, Inc. | ||
| Zephyr Endobronchial Valve System | Pulmonx Corporation | ||
| Pulsar-18 T3 Peripheral Self-Expanding Nitinol Stent System | Biotronik AG | ||
| SpineSeal Spine Sealant | Pramand, LLC | ||
| PD-L1 IHC 22C3 pharmDx | Agilent Technologies, Inc. | ||
| Astron Peripheral Self-Expanding Nitinol Stent System | Biotronik AG |
Recalls
11 recall events this week; the 10 below lead the list.
| Firm | Product | Reason | Catalog rows | Posted |
|---|---|---|---|---|
| AVID Medical, Inc. | Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01 | Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator. | 2 | |
| Baxter Healthcare Corporation | Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No | Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications. | 1 | |
| Boston Scientific Corporation | Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/035 B | Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism. | 1 | |
| AVID Medical, Inc. | Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02. | Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides. | 1 | |
| New York Embroidery Studio, Inc. | New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100 gowns per shipping case. | Gowns do not consistently meet the minimum liquid-barrier performance required. | 1 | |
| Intervascular, Sas | Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034; | Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP). | 1 | |
| Criticare Technologies, Inc. | nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R | Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay. | 1 | |
| Cardinal Health 200, LLC | Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog | The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection | 2 | |
| DeRoyal Industries Inc | REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series | Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle. | 1 | |
| Becton, Dickinson and Company | ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin o | Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables. | 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 | |
| Millennium | Avalign Technologies, Inc. | Surgical soft-tissue manipulation forceps, tweezers-like, reusable | |
| Unitron ChargerGo RIC S-RX | Sonova AG | Noninvasive device battery charger | |
| Millennium | Avalign Technologies, Inc. | Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable | |
| Moxi S9-RX | Sonova AG | Air-conduction hearing aid, receiver-in-canal | |
| Velora RED | Omm Imports Inc. | Blue/red/infrared phototherapy lamp | |
| Moxi S7-RX | Sonova AG | Air-conduction hearing aid, receiver-in-canal | |
| Aligned Medical Solutions | Aligned Medical Solutions | ENT surgical procedure kit, non-medicated, single-use | |
| Relate5.0 Platinum RIC 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)
2,651 ARTG device entries this week; the 10 below lead the list.
| Brand | Manufacturer | Sponsor | Class | Effective |
|---|---|---|---|---|
| MeniSept | Menicon Co Ltd | Menicon Australia Pty Ltd | Class IIb | |
| MeniSept | Menicon Co Ltd | Menicon Australia Pty Ltd | Class IIb | |
| Cragg-McNamara™ Valved Infusion Catheter | Micro Therapeutics Inc DBA ev3 Neurovascular | Medtronic Australasia Pty Ltd | Class IIb | |
| Cragg-McNamara™ Valved Infusion Catheter | Micro Therapeutics Inc DBA ev3 Neurovascular | Medtronic Australasia Pty Ltd | Class IIb | |
| KLS Martin | KLS Martin SE & Co KG | KLS Martin Australia Pty Ltd | Class IIb | |
| KLS Martin | KLS Martin SE & Co KG | KLS Martin Australia Pty Ltd | Class IIb | |
| KLS Martin | KLS Martin SE & Co KG | KLS Martin Australia Pty Ltd | Class IIb | |
| KLS Martin | KLS Martin SE & Co KG | KLS Martin Australia Pty Ltd | Class IIb | |
| KLS Martin | KLS Martin SE & Co KG | KLS Martin Australia Pty Ltd | Class IIb | |
| KLS Martin | KLS Martin SE & Co KG | KLS Martin Australia Pty Ltd | Class IIb |
Canada (Health Canada MDALL)
234 new device licences this week; the 10 below lead the list.
| Device | Company | Class | Licensed |
|---|---|---|---|
| Sinclair Dental Contra Angle Latch One Piece (E-Type) | Sinclair Dental Co. Ltd. | 2 | |
| Sinclair Dental Contra Angle Snap-On One Piece | Sinclair Dental Co. Ltd. | 2 | |
| Sinclair Dental Contra Angle Push-Button Latch One Piece | Sinclair Dental Co. Ltd. | 2 | |
| Sinclair Dental Contra Angle Prophy Screw-in One Piece (E-Type) | Sinclair Dental Co. Ltd. | 2 | |
| Sinclair Dental Prophy Nosecone | Sinclair Dental Co. Ltd. | 2 | |
| SHEATHES3D Seamless Viral Barrier, Latexfree, Pregelled, Polyurethane, Nonsterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled | Sheathing Technologies, Inc. | 2 | |
| Auvon Tens and Muscle Stimulator | Shenzhen Astec Technology Co., Ltd. | 2 | |
| Ceretone Horizon Bte Hearing Aid | Hearlux Inc. | 2 | |
| Biatain Silicone Foam Dressing | Coloplast A/S | 2 | |
| Biatain Silicone Lite Foam Dressing | Coloplast A/S | 2 |
Drug Labels
5 label effective dates this week; the 4 below lead the list.
| Brand | Generic | Manufacturer | Effective |
|---|---|---|---|
| leader clearlax | Polyethylene Glycol 3350 | Cardinal Health 110, LLC. dba Leader | |
| Varenicline | Varenicline | A-S Medication Solutions | |
| Gillette ClearShield Sport Active Clear | Aluminum Zirconium Octachlorohydrex Gly | The Procter & Gamble Manufacturing Company | |
| Varenicline | Varenicline Tartrate | RemedyRepack 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)
269,229 literature records this week; the 10 below lead the list.
| PMID | Title | Journal | Revised |
|---|---|---|---|
| Sustainability and nutritional composition of food choices in hospital canteens: a pre-post intervention study. | Frontiers in nutrition | ||
| A scalable outpatient framework for BI-RADS 2-4B breast nodule management: an iodine-DMSO transdermal protocol. | Frontiers in health services | ||
| MSAR: multi-stage adversarial representation learning for robust financial entity-level sentiment analysis. | Frontiers in artificial intelligence | ||
| Factors associated with bystander intervention in cyberbullying: a systematic review. | Frontiers in psychology | ||
| A four-dimensional spatial atlas of spinal cord injury reveals predominant Spp1-integrin signaling driving microglia-fibroblast crosstalk in fibrotic niches. | Frontiers in immunology | ||
| Soluble starch synthase IVa determines cooked rice elongation in waxy and non-waxy rices (Oryza sativa L.). | Frontiers in plant science | ||
| Comparison of vonoprazan and proton pump inhibitors for the management of gastric post-endoscopic submucosal dissection ulcers and preventing delayed bleeding: a meta-analysis of randomized controlled | Frontiers in medicine | ||
| Misconceptions and health-seeking behavior among diabetic patients regarding foot ulcers: the hidden role of circulatory awareness in preventing amputation. | Frontiers in public health | ||
| Giant lipomatous tumor of the left back favoring atypical lipomatous tumor/well-differentiated liposarcoma: a case report. | Journal of surgical case reports | ||
| Impact of a 2-year structured program on physical fitness and physical activity in T2D patients with rapid renal function decline-the ACTIDIANE RCT. | Frontiers in sports and active living |
Literature by Subject (MeSH)
576,053 annotated literature records this week; the 10 below lead the list.
| MeSH heading | Articles |
|---|---|
| Humans | 205,267 |
| Female | 112,101 |
| Male | 103,568 |
| Animals | 66,964 |
| Adult | 60,686 |
| Middle Aged | 57,001 |
| Aged | 41,292 |
| Young Adult | 24,312 |
| Mice | 21,254 |
| Adolescent | 20,645 |
Insider Buying (Form 4)
365 open-market insider purchases this week; the 10 below lead the list.
| Ticker | Owner | Traded | Shares | Value (USD) |
|---|---|---|---|---|
| LEN, LEN.B | Berkshire Hathaway Inc. | 1,381,397 | 105,644,547 | |
| LEN, LEN.B | Berkshire Hathaway Inc. | 695,014 | 54,889,317 | |
| Berkshire Hathaway Inc. | 653,320 | 52,839,466 | ||
| LEN, LEN.B | Berkshire Hathaway Inc. | 667,118 | 51,861,287 | |
| Berkshire Hathaway Inc. | 534,256 | 43,619,906 | ||
| Berkshire Hathaway Inc. | 492,124 | 39,923,418 | ||
| Tan Anthony Ping Yeow | 10,350,000 | 29,876,310 | ||
| Monroe James III | 361,600 | 29,839,232 | ||
| Cohen Ryan | 1,150,680 | 26,393,722 | ||
| Lincoln Financial Investments Corp | 2,460,630 | 25,000,000 |
Academica Weekly is assembled and published automatically each week. This issue covers 21 September 2026 to 27 September 2026 and was built on 27 September 2026.