Academica Weekly: The Primary Record for the Week Ending 6 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 31 August 2026 to 6 September 2026: 9 recall events; 119 510(k) clearances; 239 new Health Canada device licences; 6,599 ARTG device entries; 438 open-market insider purchases.
9 recall events
119 510(k) clearances
239 new Health Canada device licences
6599 ARTG device entries
119510(k) clearances308PMA decisions9recall events352,949adverse event reports355,195device event reports27,811device listings6,599ARTG device entries239new device licences498label effective dates62,691new provider enumerations15,384,974industry payments95medtech patent grants98,663literature records438open-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 | 10 August 2026 | 27 days behind |
| FDA 510(k) | 16 August 2026 | 21 days behind |
| FDA PMA | 14 August 2026 | Current |
| FDA recalls | 2 September 2026 | Current |
| FDA guidance | 28 August 2026 | Current |
| FAERS | 30 June 2026 | Current |
| MAUDE | 31 July 2026 | Current |
| GUDID | 22 April 2026 | 137 days behind |
| TGA ARTG | 5 September 2026 | Current |
| Health Canada | 4 September 2026 | Current |
| FDA drug labels | 3 September 2026 | 3 days behind |
| NPPES | 8 August 2026 | Current |
| Open Payments | 31 December 2024 | 614 days behind |
| USPTO | 10 February 2026 | 208 days behind |
| PubMed | 5 September 2026 | Current |
| SEC Form 4 | 4 September 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
9 recall events this week.
| Firm | Product | Reason | Catalog rows | Posted |
|---|---|---|---|---|
| Boston Scientific Corporation | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7) | There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic inte | 3 | |
| Fresenius Medical Care Renal Therapies Group, LLC | 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. | 4 | |
| B Braun Medical Inc | Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025 | Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label. | 1 | |
| Medos International Sarl | Velys Enabling Tech Robotic-Assist Station REF: 451611001 | Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning. | 1 | |
| Philips North America Llc | Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. | 4 | |
| Baxter Healthcare Corporation | Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains. | 2 | |
| Medline Industries, LP | Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREOP KIT, Model Number: DYKS1583A; 4) CATARACT PREOP KIT, Model Number: DYKS1583B | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is co | 16 | |
| Medline Industries, LP | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER 2 ACC | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lea | 13 | |
| Johnson & Johnson Surgical Vision, Inc. | HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF: 10301016 (EU) | Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. ins | 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 |
|---|---|---|---|
| Na | Fehling Instruments GmbH & Co. KG | General-purpose surgical scissors, reusable | |
| Dododots | Dodo Ventures Sdn. Bhd. | Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial | |
| QUASAR Standalone ACIF System | GS Medical Co., Ltd. | Metallic spinal interbody fusion cage | |
| Lumira™ LED Curing Light | Premier Dental Products Company | Dental/surgical polymerization lamp | |
| Tangible Fill | Dry Eye Innovations, LLC | Contact lens rinsing solution | |
| TrellOss®-MCP | Nexxt Spine, LLC | Spinal fixation plate, non-bioabsorbable | |
| Na | Fehling Instruments GmbH & Co. KG | General-purpose surgical scissors, reusable | |
| Esaote MyLabX1 Ultrasound Transducer_Linear Array | Qisda Corporation | Extracorporeal ultrasound imaging transducer, hand-held | |
| QUASAR Standalone ACIF System | GS Medical Co., Ltd. | Metallic spinal interbody fusion cage | |
| Suction Tube Atraumatic 6 FR 150MM | Rsb Spine LLC | Surgical/emergency suction cannula, non-illuminating, reusable |
Australia (TGA ARTG)
6,599 ARTG device entries this week; the 10 below lead the list.
| Brand | Manufacturer | Sponsor | Class | Effective |
|---|---|---|---|---|
| BeSmooth Peripheral Stent Graft System | Bentley InnoMed GmbH | Device Technologies Australia Pty Ltd | Class III | |
| BeSmooth Peripheral Stent Graft System | Bentley InnoMed GmbH | Device Technologies Australia Pty Ltd | Class III | |
| BeSmooth Peripheral Stent Graft System | Bentley InnoMed GmbH | Device Technologies Australia Pty Ltd | Class III | |
| BeSmooth Peripheral Stent Graft System | Bentley InnoMed GmbH | Device Technologies Australia Pty Ltd | Class III | |
| BeSmooth Peripheral Stent Graft System | Bentley InnoMed GmbH | Device Technologies Australia Pty Ltd | Class III | |
| BeSmooth Peripheral Stent Graft System | Bentley InnoMed GmbH | Device Technologies Australia Pty Ltd | Class III | |
| BeSmooth Peripheral Stent Graft System | Bentley InnoMed GmbH | Device Technologies Australia Pty Ltd | Class III | |
| BeSmooth Peripheral Stent Graft System | Bentley InnoMed GmbH | Device Technologies Australia Pty Ltd | Class III | |
| BeSmooth Peripheral Stent Graft System | Bentley InnoMed GmbH | Device Technologies Australia Pty Ltd | Class III | |
| BeSmooth Peripheral Stent Graft System | Bentley InnoMed GmbH | Device Technologies Australia Pty Ltd | Class III |
Canada (Health Canada MDALL)
239 new device licences this week; the 10 below lead the list.
| Device | Company | Class | Licensed |
|---|---|---|---|
| Tornier Hrs Tuberosity Body | Tornier Inc. | 3 | |
| Tornier Hrs Trial Tuberosity Body | Tornier Inc. | 3 | |
| H3 K36M (RM193) Rabbit Monoclonal Antibody | Cell Marque Corporation | 2 | |
| GX1 Radiofrequency Generator Kit | Boston Scientific Neuromodulation Corporation | 3 | |
| RF Output Test Plug | Boston Scientific Neuromodulation Corporation | 3 | |
| H3.3 G34W (RM263) Rabbit Monoclonal Antibody | Cell Marque Corporation | 2 | |
| Pit-1 (ZM385) Mouse Monoclonal Antibody | Cell Marque Corporation | 2 | |
| Carbonic Anhydrase Ix (Ca Ix) (EP161) Rabbit Monoclonal Primary Antibody | Cell Marque Corporation | 2 | |
| Imagegrid Streamvue | Candelis Inc. | 2 | |
| Reusable Bipolar Forceps, Non-Stick, Bayonet, Irrigating, Insulated | Kirwan Surgical Products, LLC | 2 |
Drug Labels
498 label effective dates this week; the 10 below lead the list.
| Brand | Generic | Manufacturer | Effective |
|---|---|---|---|
| Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | RemedyRepack Inc. | |
| Bmnp Antimonium Crudum | Antimonium Crudum | Total Operations Management LLC DBA:Bestmade Natural Products Micro | |
| Fluticasone | Fluticasone Propionate | Yyba Corp | |
| Bmnp Arnica Montana | Arnica Montana | Total Operations Management LLC DBA:Bestmade Natural Products Micro | |
| Roflumilast | Roflumilast | Amici Pharma Inc. | |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Walgreen Co. | |
| Henry Schein Povidone-Iodine Prep Pad | Povidone-Iodine | Henry Schein, Inc. | |
| Fluconazole | Fluconazole | RemedyRepack Inc. | |
| Fiber Caplets | Calcium Polycarbophil | The Kroger Co. | |
| Ibuprofen | Ibuprofen | Shield Pharmaceuticals Corp |
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)
98,663 literature records this week; the 10 below lead the list.
| PMID | Title | Journal | Revised |
|---|---|---|---|
| Associations among creativity disposition, psychological resilience, and emotional states in contemporary dance practitioners of intangible cultural heritage. | Frontiers in psychology | ||
| Left-Sided Pseudomonas Infective Endocarditis Presenting with Septic Shock and Ischemic Stroke in a Non-Injection Drug User Receiving PD-L1 Inhibitor Therapy. | Cureus | ||
| Aluminum-based salts: an unorthodox but simple way to treat molluscum contagiosum and cutaneous warts. | F1000Research | ||
| Insights Into Urogenital Tuberculosis: Impact of Microbiological Diagnosis. | Cureus | ||
| Military Sexual Trauma and Eating Disorders: A Systematic Review and Meta-Analysis. | Trauma, violence & abuse | ||
| Optimizing the structure of urban woody plantings for a warming climate: a frequency-weighted exposure framework for woody species in Chongqing, China. | Frontiers in plant science | ||
| Management of a Symptomatic Maxillary Implant Adjacent to the Schneiderian Membrane Using Cone Beam Computed Tomography (CBCT)-Guided Explantation and Reimplantation: A Case Report. | Cureus | ||
| Emergency Department Implementation of Care Models for Individuals Experiencing Family and Domestic Violence and Abuse: A Systematic Scoping Review. | Trauma, violence & abuse | ||
| Distress disclosure and health behaviours in patients with stroke: a theory-informed serial mediation model of social support, self-efficacy, and self-management. | Frontiers in neurology | ||
| Efficacy and safety of traditional Chinese medicine herbal hand-foot bath combined with arnebia oil for chemotherapy-induced hand-foot syndrome refractory to standard treatment: a single-arm prospecti | Frontiers in medicine |
Literature by Subject (MeSH)
187,542 annotated literature records this week; the 10 below lead the list.
| MeSH heading | Articles |
|---|---|
| Humans | 92,662 |
| Female | 54,227 |
| Male | 51,077 |
| Middle Aged | 30,085 |
| Adult | 29,543 |
| Animals | 24,984 |
| Aged | 21,563 |
| Young Adult | 11,217 |
| Retrospective Studies | 10,271 |
| Adolescent | 9,758 |
Insider Buying (Form 4)
438 open-market insider purchases this week; the 10 below lead the list.
| Ticker | Owner | Traded | Shares | Value (USD) |
|---|---|---|---|---|
| BlueArc Capital Management, LLC | 8,671,826 | 99,379,127 | ||
| Cascade Investment, L.l.c. | 329,200 | 73,500,699 | ||
| Cascade Investment, L.l.c. | 301,000 | 66,803,529 | ||
| Cascade Investment, L.l.c. | 251,400 | 55,566,862 | ||
| NONE | Waxman Alan | 1,661,507 | 47,818,171 | |
| Cascade Investment, L.l.c. | 204,800 | 45,604,191 | ||
| N/A | Manufacturers Life Reinsurance Ltd | 2,693,701 | 43,988,145 | |
| BlueArc Capital Management, LLC | 3,679,853 | 40,000,000 | ||
| BlueArc Capital Management, LLC | 2,446,184 | 25,000,000 | ||
| N/A | Manufacturers Life Insurance Co (Bermuda Branch) | 1,408,071 | 22,993,803 |
Academica Weekly is assembled and published automatically each week. This issue covers 31 August 2026 to 6 September 2026 and was built on 6 September 2026.