Academica Weekly: The Primary Record for the Week Ending 23 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 17 August 2026 to 23 August 2026: 7 recall events; 161 510(k) clearances; 123 new Health Canada device licences; 9,225 ARTG device entries; 527 open-market insider purchases.
7 recall events
161 510(k) clearances
123 new Health Canada device licences
9225 ARTG device entries
161510(k) clearances315PMA decisions7recall events352,949adverse event reports355,195device event reports27,811device listings9,225ARTG device entries123new device licences454label effective dates62,691new provider enumerations15,384,974industry payments95medtech patent grants106,965literature records527open-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 | 27 July 2026 | 27 days behind |
| FDA 510(k) | 7 August 2026 | 16 days behind |
| FDA PMA | 8 August 2026 | Current |
| FDA recalls | 19 August 2026 | Current |
| FDA guidance | 14 August 2026 | Current |
| FAERS | 30 June 2026 | Current |
| MAUDE | 31 July 2026 | Current |
| GUDID | 22 April 2026 | 123 days behind |
| TGA ARTG | 21 August 2026 | Current |
| Health Canada | 21 August 2026 | Current |
| FDA drug labels | 21 August 2026 | Current |
| NPPES | 8 August 2026 | Current |
| Open Payments | 31 December 2024 | 600 days behind |
| USPTO | 10 February 2026 | 194 days behind |
| PubMed | 22 August 2026 | Current |
| SEC Form 4 | 21 August 2026 | Current |
510(k) Clearances
161 510(k) clearances this week; the 10 below lead the list.
| K number | Device | Applicant | Class | Decision |
|---|---|---|---|---|
| Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. | 1 | ||
| mdprostate | Mediaire GmbH | 2 | ||
| Metrix COVID Test; Metrix COVID Test Pro | Aptitude Medical Systems, Inc. | 2 | ||
| Zamenix P | Roen Surgical, Inc. | 2 | ||
| Aperio GT 450 DX; Aperio GT 180 DX | Leica Biosystems Imaging, Inc. | 2 | ||
| Aperio iQC DX Software | Leica Biosystems Imaging, Inc. | 2 | ||
| Intuitive Endoluminal Gastrointestinal System (IG1000) | Intuitive Surgical, Inc. | 2 | ||
| Zenition 30 | Philips Medical Systems Nederland B.V. | 2 | ||
| EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | 2 | ||
| Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2 |
PMA Approvals
315 PMA decisions this week; the 10 below lead the list.
| PMA | Device | Applicant | Decision |
|---|---|---|---|
| Master Restore; Itrel; Synergy; Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces; Specify | Medtronic Neuromodulation | ||
| SynchroMed Infusion System; Ascenda Intrathecal Catheters | Medtronic, Inc. | ||
| InterStim Therapy System, Verify Evaluation System | Medtronic Neuromodulation | ||
| Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense | Medtronic, Inc. | ||
| TactiSys Quartz Equipment; Ampere Generator | Abbott Medical | ||
| Ampere Generator | Irvine Biomedical, Inc. | ||
| TactiSys Quartz Equipment; Ampere Generator | St Jude Medical | ||
| Ampere Generator | Abbott Medical | ||
| Ampere Generator | St Jude Medical | ||
| Guardant360® CDx | Guardant Health, Inc. |
Recalls
7 recall events this week.
| Firm | Product | Reason | Catalog rows | Posted |
|---|---|---|---|---|
| ConvaTec, Inc | Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 4 | Urostomy Pouches may leak from cap during use. | 1 | |
| BMC Medical Co., Ltd. | BMC/REACTHEALTH Luna G3 APAP REF LG 3600 | Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse | 1 | |
| restor3d Inc. | Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware produc | Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws. | 1 | |
| Fort Defiance Industries, LLC | Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131 | The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path. | 1 | |
| Medtronic MiniMed, Inc. | MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782; | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycem | 3 | |
| Siemens Healthcare Diagnostics, Inc. | Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL | Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-th | 2 | |
| Beckman Coulter Inc. | Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C6352 | a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomiz | 2 |
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 |
|---|---|---|---|
| Anyplus Peek Cage System | GS Medical Co., Ltd. | Polymeric spinal interbody fusion cage | |
| Fmt | Metko Medikal Ve Tibbi Cihazlar Dis Ticaret Limited Sirketi | General-purpose patient temperature probe, single-use | |
| Struxxure™ Anterior Cervical Plate and Screws | Nexxt Spine, LLC | General internal orthopaedic fixation system implantation kit | |
| Osteotome | Dentis Co. ,ltd | Chisel/osteotome blade handle | |
| K2-HF BLEACH DENTINE, BD-3, 50g. | Yeti Dentalprodukte GmbH | Dental appliance fabrication material, ceramic | |
| s-Clean Link Abutment ScanPost | Dentis Co. ,ltd | Dental implant suprastructure, temporary, preformed, single-use | |
| QUASAR Standalone ACIF System | GS Medical Co., Ltd. | Metallic spinal interbody fusion cage | |
| Skirt | Shielding International Inc. | Radiation shielding apron | |
| Soundfuse | HongKong Pishon Medical Equipment Co., Limited | Bath back rest/seat | |
| Clareon TruPlus | Alcon Laboratories, Inc. | Posterior-chamber intraocular lens, pseudophakic |
Australia (TGA ARTG)
9,225 ARTG device entries this week; the 10 below lead the list.
| Brand | Manufacturer | Sponsor | Class | Effective |
|---|---|---|---|---|
| Baby Gorilla/Gorilla Plating System | Paragon 28 Inc | Zimmer Biomet Pty Ltd | Class IIb | |
| Baby Gorilla/Gorilla Plating System | Paragon 28 Inc | Zimmer Biomet Pty Ltd | Class IIb | |
| Baby Gorilla/Gorilla Plating System | Paragon 28 Inc | Zimmer Biomet Pty Ltd | Class IIb | |
| Baby Gorilla/Gorilla Plating System | Paragon 28 Inc | Zimmer Biomet Pty Ltd | Class IIb | |
| Baby Gorilla/Gorilla Plating System | Paragon 28 Inc | Zimmer Biomet Pty Ltd | Class IIb | |
| Baby Gorilla/Gorilla Plating System | Paragon 28 Inc | Zimmer Biomet Pty Ltd | Class IIb | |
| Baby Gorilla/Gorilla Plating System | Paragon 28 Inc | Zimmer Biomet Pty Ltd | Class IIb | |
| Baby Gorilla/Gorilla Plating System | Paragon 28 Inc | Zimmer Biomet Pty Ltd | Class IIb | |
| Baby Gorilla/Gorilla Plating System | Paragon 28 Inc | Zimmer Biomet Pty Ltd | Class IIb | |
| Baby Gorilla/Gorilla Plating System | Paragon 28 Inc | Zimmer Biomet Pty Ltd | Class IIb |
Canada (Health Canada MDALL)
123 new device licences this week; the 10 below lead the list.
| Device | Company | Class | Licensed |
|---|---|---|---|
| Skin Lesion Excision Tray | 8083851 Canada Inc. Operating as Pama Manufacturing & Sterilization | 2 | |
| Skin Biopsy Tray -Naevus | 8083851 Canada Inc. Operating as Pama Manufacturing & Sterilization | 2 | |
| Radiology Joint Procedure Pain Management Tray | 8083851 Canada Inc. Operating as Pama Manufacturing & Sterilization | 2 | |
| Ritus Peritoneal Dialysis Accessory Medical Grade Silicone Adhesive, Type A | Mozarc Medical US LLC Dba Covidien LLC | 2 | |
| Mps 3 Console Pole Mount Plate | Quest Medical, Inc. | 2 | |
| MRI Planner | Ge Medical Systems LLC | 3 | |
| Gelport Hand Access Laparoscopic System | Applied Medical Resources Corporation | 2 | |
| Flextip Bipolar Electrodes, Single-Use | Sutter Medizintechnik GmbH | 2 | |
| Raystation V2025 SP1 | Raysearch Laboratories Ab (Publ) | 3 | |
| Rayplan V2025 SP1 | Raysearch Laboratories Ab (Publ) | 3 |
Drug Labels
454 label effective dates this week; the 10 below lead the list.
| Brand | Generic | Manufacturer | Effective |
|---|---|---|---|
| Anti-Diarrheal | Loperamide Hcl | Redpharm Drug | |
| nitroglycerin | Nitroglycerin | Redpharm Drug | |
| Dicyclomine hydrochloride | Dicyclomine Hydrochloride | Redpharm Drug | |
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium Bromide and Albuterol Sulfate | Redpharm Drug | |
| CVS dye-free childrens allergy | Diphenhydramine Hydrochloride | CVS Pharmacy | |
| Stay Ageless Tinted Mineral Sunscreen | Broad Spectrum SPF30 | MedSpa By Beauty Bar LLC | |
| Cyproheptadine Hydrochloride | Cyproheptadine Hydrochloride | Bryant Ranch Prepack | |
| Phentermine Hydrochloride | Phentermine Hydrochloride | Preferred Pharmaceuticals, Inc. | |
| meloxicam | Meloxicam | Sportpharm LLC | |
| Prazosin Hydrochloride | Prazosin Hydrochloride | Preferred Pharmaceuticals 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)
106,965 literature records this week; the 10 below lead the list.
| PMID | Title | Journal | Revised |
|---|---|---|---|
| Nitrate availability influences powdery mildew resistance and secondary metabolism in Gerbera hybrida. | Frontiers in plant science | ||
| Berberine induces PD-L1 degradation via the autophagy-lysosome pathway through the PI3K-Akt pathway and enhances immunogenic cell death in triple-negative breast cancer. | Frontiers in immunology | ||
| Postpartum glucose follow-up after gestational diabetes in China: provider and institutional determinants in a multicenter survey across urban public hospitals. | Frontiers in endocrinology | ||
| Study on the relationship between disease progression and changes in Th17/Treg levels in patients with relapsing-remitting multiple sclerosis. | Frontiers in neurology | ||
| Admission direct bilirubin and direct bilirubin-to-lymphocyte ratio as exploratory markers of early severity and in-hospital functional status in acute ischemic stroke. | Frontiers in stroke | ||
| Right-heart reverse remodeling and heart failure symptom outcomes after catheter ablation in patients with persistent atrial fibrillation, heart failure, and functional tricuspid regurgitation. | Frontiers in cardiovascular medicine | ||
| Serum interleukin-10 levels and mortality in severe fever with thrombocytopenia syndrome: a systematic review and meta-analysis. | Frontiers in immunology | ||
| Association of 25-hydroxyvitamin D and chemerin with metabolic syndrome components in individuals with type 2 diabetes mellitus. | Frontiers in medicine | ||
| Associations of Cholesin and GPR146 with atherosclerotic plaque stability: integrated bioinformatics and functional analyses. | Frontiers in cardiovascular medicine | ||
| The auditory nerve glial transition zone is a focal site of age-related immune-myelin interactions. | Frontiers in immunology |
Literature by Subject (MeSH)
167,697 annotated literature records this week; the 10 below lead the list.
| MeSH heading | Articles |
|---|---|
| Humans | 83,145 |
| Female | 47,597 |
| Male | 44,287 |
| Middle Aged | 26,927 |
| Adult | 25,202 |
| Animals | 24,395 |
| Aged | 19,922 |
| Mice | 10,106 |
| Young Adult | 8,890 |
| Retrospective Studies | 8,889 |
Insider Buying (Form 4)
527 open-market insider purchases this week; the 10 below lead the list.
| Ticker | Owner | Traded | Shares | Value (USD) |
|---|---|---|---|---|
| Catalyst4, Inc. | 4,400,000 | 50,072,000 | ||
| Cascade Investment, L.l.c. | 206,800 | 44,445,925 | ||
| Cascade Investment, L.l.c. | 200,125 | 43,607,661 | ||
| Cascade Investment, L.l.c. | 178,844 | 39,795,277 | ||
| Cascade Investment, L.l.c. | 149,250 | 32,197,582 | ||
| Walters Group | 4,335,000 | 15,172,500 | ||
| Warren Kelcy L | 647,968 | 13,775,800 | ||
| Chen Hung-Wen | 536,667 | 7,550,004 | ||
| Warren Kelcy L | 352,032 | 7,487,721 | ||
| N/A | John Hancock Stable Value Fund Collective Investment Trust | 301,659 | 6,000,000 |
Academica Weekly is assembled and published automatically each week. This issue covers 17 August 2026 to 23 August 2026 and was built on 23 August 2026.