Academica Weekly: The Primary Record for the Week Ending 16 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 10 August 2026 to 16 August 2026: 13 recall events; 165 510(k) clearances; 209 new Health Canada device licences; 1,653 ARTG device entries; 537 open-market insider purchases.
13 recall events
165 510(k) clearances
209 new Health Canada device licences
1653 ARTG device entries
165510(k) clearances302PMA decisions13recall events352,949adverse event reports355,195device event reports27,811device listings1,653ARTG device entries209new device licences398label effective dates62,691new provider enumerations15,384,974industry payments95medtech patent grants615,502literature records537open-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 | 7 August 2026 | 9 days behind |
| FDA 510(k) | 31 July 2026 | 16 days behind |
| FDA PMA | 31 July 2026 | Current |
| FDA recalls | 12 August 2026 | Current |
| FDA guidance | 5 August 2026 | 11 days behind |
| FAERS | 30 June 2026 | Current |
| MAUDE | 31 July 2026 | Current |
| GUDID | 22 April 2026 | 116 days behind |
| TGA ARTG | 14 August 2026 | Current |
| Health Canada | 14 August 2026 | Current |
| FDA drug labels | 12 August 2026 | 4 days behind |
| NPPES | 8 August 2026 | Current |
| Open Payments | 31 December 2024 | 593 days behind |
| USPTO | 10 February 2026 | 187 days behind |
| PubMed | 15 August 2026 | Current |
| SEC Form 4 | 14 August 2026 | Current |
510(k) Clearances
165 510(k) clearances this week; the 10 below lead the list.
| K number | Device | Applicant | Class | Decision |
|---|---|---|---|---|
| Hearing Aid Feature | Samsung Electronics Co., Ltd. | 2 | ||
| Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | Orthalign, Inc. | 2 | ||
| UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | 2 | ||
| Flexitouch® Plus Advanced Pneumatic Compression System | Tactile Medical | 2 | ||
| Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Bürmoos GmbH | 2 | ||
| 0909Fce, 0909Fce-Hs | Rayence Co., Ltd. | 2 | ||
| Affinity | Hermes Medical Solutions AB | 2 | ||
| WatchPAT SW | Itamar Medical , Ltd. | 2 | ||
| Shield System (Siemens 30x40) | Radiaction , Ltd. | 2 | ||
| MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | Siemens Healthineers AG | 2 |
PMA Approvals
302 PMA decisions this week; the 10 below lead the list.
| PMA | Device | Applicant | Decision |
|---|---|---|---|
| Adapta, Versa, Sensia IPG (ADDR03, ADDR06, ADSR01, SEDR01, SESR01); Adapta, Versa, Sensia IPG (SEDRL1); Adapta, Versa, S | Medtronic, Inc. | ||
| Adapta, Versa, Sensia IPG (ADDR03, ADDRL1, ADDRS1, ADSR01, ADSR03, SED01, SES01, SESR01), Adapta, Versa, Sensia IPG (SED | Medtronic, Inc. | ||
| Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) | Medtronic, Inc. | ||
| Hintermann Series H3 Total Ankle Replacement System | Dt Medtech, LLC | ||
| Belotero® Intense (+) Lidocaine | Merz North America, Inc. | ||
| Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4) Brava Quad | Medtronic Cardiac Rhythm Disease Management | ||
| Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I | Medtronic Cardiac Rhythm Disease Management | ||
| Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) | Medtronic, Inc. | ||
| Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4);Brava Quad | Medtronic Cardiac Rhythm Disease Management | ||
| Adapta, Versa, Sensia IPG (ADDR06, ADDRS1, ADSR01, ADSR03, ADSR06, SEDR01, SESR01); Adapta, Versa, Sensia IPG (SEDRL1); | Medtronic, Inc. |
Recalls
13 recall events this week; the 10 below lead the list.
| Firm | Product | Reason | Catalog rows | Posted |
|---|---|---|---|---|
| BioFire Diagnostics, LLC | BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic | Due to increase in false negative results | 1 | |
| Erbe USA Inc | ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 | A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cry | 1 | |
| Bioporto Diagnostics A/S | ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System. | The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users. | 1 | |
| Spectra Medical Devices, Llc | Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and ind | Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammat | 1 | |
| Waldemar Link GmbH & Co. KG (Mfg Site) | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16 | The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative | 1 | |
| Straumann USA LLC | Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form | Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest. | 1 | |
| Baxter Healthcare Corporation | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets | Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position. | 1 | |
| Philips Medical Systems Nederland B.V. | Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models ar | Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movement | 1 | |
| Straumann USA LLC | GM Helix Implant, Endosseous Dental Implant Article No. 109.984 | There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during insta | 1 | |
| OBP Medical Corporation | OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1 | There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider. | 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 |
|---|---|---|---|
| BioFlo DuraMax® | Merit Medical Systems, Inc. | Double-lumen haemodialysis catheter, implantable | |
| Skirt | Shielding International Inc. | Radiation shielding apron | |
| Struxxure™ Anterior Cervical Plate and Screws | Nexxt Spine, LLC | General internal orthopaedic fixation system implantation kit | |
| TrellOss®-MCP | Nexxt Spine, LLC | Spinal fixation plate, non-bioabsorbable | |
| Dododots | Dodo Ventures Sdn. Bhd. | Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial | |
| UltraStim Snap Blue | Axelgaard Manufacturing Co., Ltd. | Transcutaneous electrical stimulation electrode, single-use | |
| Reamer | Dentis Co. ,ltd | Steel dental bur, reusable | |
| QUASAR Standalone ACIF System | GS Medical Co., Ltd. | Metallic spinal interbody fusion cage | |
| i-Clean Neck Profiler | Dentis Co. ,ltd | Fixture/appliance dental drill bit, reusable | |
| Clareon TruPlus | Alcon Laboratories, Inc. | Posterior-chamber intraocular lens, pseudophakic |
Australia (TGA ARTG)
1,653 ARTG device entries this week; the 10 below lead the list.
| Brand | Manufacturer | Sponsor | Class | Effective |
|---|---|---|---|---|
| Newport | SeaSpine Orthopedics Corporation | Device Technologies Australia Pty Ltd | Class IIb | |
| Jet Pro | Tristel Solutions Limited | Tristel Pty Ltd | Class IIb | |
| So FILL | France Developpement Electronique | Interpharma Pty Ltd | Class IIa | |
| Tristel DUO OPH | Tristel Solutions Limited | Tristel Pty Ltd | Class IIb | |
| Tristel Protect Bag | Tristel Solutions Limited | Tristel Pty Ltd | Class 1 | |
| Tristel Protect Bag | Tristel Solutions Limited | Tristel Pty Ltd | Class 1 | |
| Tristel CLEAN | Tristel Solutions Limited | Tristel Pty Ltd | Class 1 | |
| Tristel DUO OPH | Tristel Solutions Limited | Tristel Pty Ltd | Class IIb | |
| DRY/DUO Wipes | Tristel Solutions Limited | Tristel Pty Ltd | Class 1 | |
| Varian Treatment | Varian Medical Systems Inc | Varian Medical Systems Australasia Pty Ltd | Class IIb |
Canada (Health Canada MDALL)
209 new device licences this week; the 10 below lead the list.
| Device | Company | Class | Licensed |
|---|---|---|---|
| Orl Masto-Tympano | Medline Industries, LP | 2 | |
| Ibalance Pfj, Flexion Anterior Cut Guide | Arthrex Inc. | 3 | |
| Hyaregen Gel Absorbable Adhesion Barrier Gel | Bioregen Biomedical (Changzhou) Co. Ltd. | 3 | |
| Solm Nitrile Pf Exam Glove Tested for Use with Chemotherapy Drugs & Fentanyl Citrate | Hartalega Ngc Sdn. Bhd. | 2 | |
| Ti Cann Headless Screw Full Thread | Tyber Medical, LLC. | 3 | |
| Ibalance Pfj, Trochlear Reamer | Arthrex Inc. | 3 | |
| Ibalance Pfj, Im Drill | Arthrex Inc. | 3 | |
| Ibalance Pfj, Femoral Peg Drill | Arthrex Inc. | 3 | |
| Ibalance Patella Drill Guide | Arthrex Inc. | 3 | |
| Ibalance Pfj Patellofemoral, Cemented | Arthrex Inc. | 3 |
Drug Labels
398 label effective dates this week; the 10 below lead the list.
| Brand | Generic | Manufacturer | Effective |
|---|---|---|---|
| Midazolam | Midazolam Hydrochloride | Onesource Specialty Pharma Limited | |
| Nicotine | Nicotine Polacrilex | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | |
| Carbamazepine | Carbamazepine | Umedica Laboratories USA Inc. | |
| UV Skin Recovery SPF 50 Red Correcting | Zinc Oxide | CP Skin Health Group, Inc. | |
| Meloxicam | Meloxicam | Direct_Rx | |
| acyclovir | Acyclovir | C | |
| Adult Chewable Aspirin | Aspirin | Harris Teeter | |
| Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | |
| Capsaicin Cream | Capsaicin | Trifecta Pharmaceuticals USA LLC | |
| Totclear Nail Renewal | Undecylenic Acid | Good Bridge LLC |
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)
615,502 literature records this week; the 10 below lead the list.
| PMID | Title | Journal | Revised |
|---|---|---|---|
| Mitochondrial Omics in Macrophage Foam Cell Formation and Atherosclerosis. | Proteomics | ||
| "I gave birth, and then I disappeared"-women's experience of primary care follow-up and lifestyle prevention after gestational diabetes. | International journal of qualitative studies on health and well-being | ||
| Suicide Risk Identification Across Populations: Part 1 of 2 2026 Special Issues on Suicide Risk and Prevention. | Journal of the American Psychiatric Nurses Association | ||
| Regulatory T cells: From Foxp3 to tolerance-inducing therapies. | The Journal of investigative dermatology | ||
| In Memoriam George Alan Kaysen, MD, PhD (1943-2026). | Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation | ||
| Correction. | Journal of the American Academy of Dermatology | ||
| White-Centered Multilayered Retinal Hemorrhages in the Setting of Acute Leukemia. | Ophthalmology. Retina | ||
| Cardiac Myxoma Causing Left Ventricular Outflow Tract Obstruction and Syncope in Rural Tanzania. | JACC. Case reports | ||
| Percutaneous Tricuspid Valve-in-Valve Implantation With Melon Seeding During Deployment. | JACC. Case reports | ||
| The Lived Experiences of Patients and Health Care Providers During ED Triage in Saudi Arabia. | Journal of emergency nursing |
Literature by Subject (MeSH)
1,199,029 annotated literature records this week; the 10 below lead the list.
| MeSH heading | Articles |
|---|---|
| Humans | 465,005 |
| Female | 276,835 |
| Male | 254,362 |
| Middle Aged | 147,264 |
| Adult | 142,606 |
| Animals | 142,547 |
| Aged | 108,070 |
| Retrospective Studies | 53,903 |
| Young Adult | 52,234 |
| Mice | 51,155 |
Insider Buying (Form 4)
537 open-market insider purchases this week; the 10 below lead the list.
| Ticker | Owner | Traded | Shares | Value (USD) |
|---|---|---|---|---|
| Cascade Investment, L.l.c. | 261,664 | 56,228,384 | ||
| Cascade Investment, L.l.c. | 240,000 | 51,917,379 | ||
| Cascade Investment, L.l.c. | 188,460 | 40,671,945 | ||
| Cascade Investment, L.l.c. | 174,500 | 37,657,232 | ||
| OrbiMed Advisors LLC | 1,940,000 | 34,920,000 | ||
| Chimovits Erez | 1,940,000 | 34,920,000 | ||
| NONE | Qatar Investment Authority | 1,541,914 | 27,000,000 | |
| AH Bio Fund IV, L.P. | 1,100,000 | 19,800,000 | ||
| Hudson Steven Kenneth | 1,475,000 | 14,750,000 | ||
| NONE | Audax Private Credit Business, LP | 592,346 | 14,546,235 |
Academica Weekly is assembled and published automatically each week. This issue covers 10 August 2026 to 16 August 2026 and was built on 16 August 2026.