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Context Brief
The U.S. medical device market exhibits sharp concentration at the top—Medtronic, Inc. dominates with 1,877 filings over five years, followed by Boston Scientific Corporation at 1,657 and ABBOTT MEDICAL at 1,134—yet this oligopoly shows visible cracks in quality control and foreign exposure. Foreign manufacturers now command 51.9% of clearances in the last twelve months, a structural shift that opens lanes for nimble entrants willing to exploit both regulatory familiarity and cost advantages. Meanwhile, Boston Scientific is managing 113 Class I recalls and 248 ongoing corrective actions, Medline Industries entities collectively shoulder 133 Class I recalls with 924 ongoing issues, and Smiths Medical ASD faces 61 Class I events—each representing potential market share in play as hospitals and GPOs re-evaluate supplier risk and seek validated alternatives with cleaner compliance track records.
Ranked by combined 5-year activity (510(k) count + PMA records × 2 weight). Class I recall counts cover the last 3 years; ongoing = currently in-progress recalls. Click column headers to re-sort.
| Sponsor | Country | 510(k) (5y) | PMA (5y) | Recalls (3y) | Class I | Ongoing | 12mo | Codes | Most recent |
|---|---|---|---|---|---|---|---|---|---|
| Medtronic, Inc. | US | 68 | 1809 | 75 | 3 | 70 | 9 | 35 | 2026-04-23 |
| Boston Scientific Corporation | US | 114 | 1543 | 443 | 131 | 367 | 17 | 45 | 2026-05-18 |
| ABBOTT MEDICAL | US | 53 | 1081 | 38 | 7 | 38 | 13 | 19 | 2026-04-24 |
| Medtronic Neuromodulation | US | 1 | 474 | 51 | 0 | 48 | 0 | 1 | 2021-08-23 |
| Biotronik, Inc. | US | 14 | 402 | 25 | 0 | 0 | 1 | 5 | 2026-05-01 |
| Edwards Lifesciences | US | 47 | 353 | 36 | 6 | 21 | 8 | 15 | 2026-04-17 |
| Medtronic Vascular | US | 4 | 325 | 18 | 5 | 9 | 0 | 3 | 2023-10-24 |
| W. L. Gore & Associates, Inc. | US | 5 | 270 | 25 | 0 | 22 | 0 | 2 | 2025-06-02 |
| DiaSorin, Inc. | US | 13 | 208 | 4 | 0 | 3 | 1 | 9 | 2025-12-23 |
| Biosense Webster, Inc. | US | 20 | 175 | 10 | 1 | 5 | 3 | 6 | 2026-02-20 |
| Alcon Laboratories, Inc. | US | 16 | 159 | 0 | 0 | 0 | 2 | 6 | 2026-02-13 |
| Abbott Laboratories | US | 16 | 156 | 33 | 0 | 29 | 3 | 11 | 2026-04-28 |
| Roche Molecular Systems, Inc. | US | 27 | 142 | 12 | 0 | 7 | 6 | 12 | 2026-05-15 |
| CooperVision, Inc. | US | 5 | 151 | 26 | 0 | 12 | 0 | 1 | 2024-01-25 |
| Siemens Healthcare Diagnostics, Inc. | US | 32 | 120 | 209 | 0 | 163 | 6 | 27 | 2026-02-27 |
| Ventana Medical Systems, Inc. | US | 4 | 130 | 4 | 0 | 4 | 0 | 3 | 2024-12-17 |
| Integra LifeSciences Corporation | US | 11 | 120 | 72 | 2 | 61 | 1 | 6 | 2025-10-08 |
| Medtronic Minimed | US | 10 | 118 | 51 | 3 | 51 | 7 | 4 | 2026-03-12 |
| Abiomed, Inc. | US | 8 | 109 | 57 | 22 | 53 | 1 | 3 | 2025-10-08 |
| Johnson & Johnson Surgical Vision, Inc. | US | 2 | 111 | 13 | 0 | 11 | 0 | 2 | 2023-04-14 |
| Abbott Vascular | US | 4 | 107 | 32 | 18 | 14 | 0 | 3 | 2022-06-30 |
| Cochlear Americas | US | 5 | 100 | 0 | 0 | 0 | 0 | 3 | 2024-04-18 |
| Abbott Molecular, Inc. | US | 11 | 95 | 30 | 5 | 21 | 3 | 9 | 2025-09-25 |
| Allergan | US | 2 | 99 | 1 | 0 | 0 | 0 | 2 | 2021-06-02 |
| Cordis US Corp | US | 4 | 97 | 22 | 15 | 22 | 0 | 4 | 2024-06-28 |
| ETHICON, Inc. | US | 12 | 93 | 26 | 0 | 22 | 5 | 6 | 2026-05-18 |
| Roche Diagnostics | US | 41 | 77 | 0 | 0 | 0 | 13 | 34 | 2026-04-24 |
| Smith & Nephew, Inc. | US | 72 | 51 | 97 | 0 | 82 | 5 | 26 | 2026-04-06 |
| Physio-Control, Inc. | US | 2 | 79 | 26 | 0 | 22 | 1 | 2 | 2025-10-14 |
| Siemens Medical Solutions USA, Inc. | US | 153 | 2 | 230 | 16 | 144 | 18 | 16 | 2026-05-21 |
Firms with the highest Class I recall counts over the last 3 years. Class I = "reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death." A large ongoing count is the strongest distress signal — assets may be available, brand may be impaired, and customers may be open to alternatives.
| Firm | Class I | Total (3y) | Ongoing | Class I rate | Most recent | Country |
|---|---|---|---|---|---|---|
| Boston Scientific Corporation | 113 | 248 | 248 | 46% | 2026-03-30 | United States |
| MEDLINE INDUSTRIES, LP - Northfield | 72 | 582 | 582 | 12% | 2025-07-25 | United States |
| Medline Industries, LP | 61 | 342 | 342 | 18% | 2026-03-24 | United States |
| Smiths Medical ASD Inc. | 61 | 127 | 127 | 48% | 2025-04-10 | United States |
| Olympus Corporation of the Americas | 44 | 273 | 273 | 16% | 2026-03-25 | United States |
| Baxter Healthcare Corporation | 42 | 176 | 176 | 24% | 2026-02-18 | United States |
| Philips Respironics, Inc. | 36 | 38 | 38 | 95% | 2026-03-02 | United States |
| Cardinal Health 200, LLC | 30 | 99 | 96 | 30% | 2026-02-27 | United States |
| Covidien LP | 26 | 46 | 46 | 57% | 2025-09-25 | United States |
| PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 20 | 184 | 184 | 11% | 2026-04-28 | Netherlands |
| Abiomed, Inc. | 20 | 53 | 51 | 38% | 2026-02-18 | United States |
| Draeger, Inc. | 19 | 19 | 19 | 100% | 2025-11-24 | United States |
| GE Medical Systems China Co., Ltd. | 18 | 21 | 21 | 86% | 2025-11-14 | China |
| Siemens Medical Solutions USA, Inc | 16 | 71 | 71 | 23% | 2026-03-12 | United States |
| Fresenius Medical Care Holdings, Inc. | 16 | 38 | 38 | 42% | 2025-10-25 | United States |
| Datex-Ohmeda, Inc. | 14 | 14 | 14 | 100% | 2024-07-12 | United States |
| AVID Medical, Inc. | 13 | 121 | 121 | 11% | 2026-03-13 | United States |
| Hamilton Medical, Inc. | 13 | 13 | 13 | 100% | 2025-06-26 | United States |
| B Braun Medical Inc | 12 | 206 | 206 | 6% | 2026-03-19 | United States |
| Datascope Corp. | 12 | 31 | 31 | 39% | 2026-02-06 | United States |
Product codes with the highest year-over-year increase in 510(k) volume. These are the categories where the market is racing — and where a foreign entrant can ride the wave instead of fighting incumbent inertia.
| Code | Device name | Specialty | Last yr | Prior yr | Growth | Sponsors |
|---|---|---|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | 19 | 5 | +280% | 25 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | 22 | 8 | +175% | 81 |
| IYE | Accelerator, Linear, Medical | Radiology | 15 | 6 | +150% | 41 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | 12 | 5 | +140% | 17 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | 11 | 5 | +120% | 20 |
| OHS | Light Based Over The Counter Wrinkle Reduction | General, Plastic Surgery | 40 | 23 | +74% | 66 |
| HGX | Pump, Breast, Powered | Obstetrics/Gynecology | 34 | 20 | +70% | 45 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | 10 | 6 | +67% | 27 |
| IOR | Wheelchair, Mechanical | Physical Medicine | 10 | 6 | +67% | 23 |
| KGN | Wound Dressing With Animal-Derived Material(S) | Unknown | 14 | 9 | +56% | 33 |
| NAY | System, Surgical, Computer Controlled Instrument | Gastroenterology, Urology | 17 | 11 | +55% | 4 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 20 | 13 | +54% | 48 |
| OWB | Interventional Fluoroscopic X-Ray System | Radiology | 22 | 15 | +47% | 57 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 13 | 9 | +44% | 23 |
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | 30 | 21 | +43% | 60 |
| Country | Clearances | Sponsors | Avg per sponsor |
|---|---|---|---|
| US | 1513 | 879 | 1.7 |
| CN | 556 | 349 | 1.6 |
| KR | 152 | 102 | 1.5 |
| DE | 115 | 69 | 1.7 |
| JP | 81 | 26 | 3.1 |
| FR | 78 | 56 | 1.4 |
| IL | 75 | 56 | 1.3 |
| CH | 70 | 31 | 2.3 |
| TW | 53 | 41 | 1.3 |
| IT | 51 | 29 | 1.8 |
| CA | 50 | 38 | 1.3 |
| GB | 45 | 39 | 1.2 |
| NL | 37 | 22 | 1.7 |
| AU | 26 | 21 | 1.2 |
| IE | 25 | 16 | 1.6 |
| SE | 23 | 16 | 1.4 |
| ES | 23 | 17 | 1.4 |
| BR | 21 | 12 | 1.8 |
| SG | 18 | 9 | 2.0 |
| IN | 17 | 15 | 1.1 |
Product codes where ≤5 sponsors hold ≥30 clearances over 5 years — high concentration means an incumbent owns the category and is potentially vulnerable to disruption (or a new entrant must be very good to displace). These are the categories worth either avoiding (incumbent dominance) or attacking with a differentiated wedge.
| Code | Device name | Specialty | Total (5y) | Sponsors | Per sponsor |
|---|---|---|---|---|---|
| NAY | System, Surgical, Computer Controlled Instrument | Gastroenterology, Urology | 50 | 2 | 25.0 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | Microbiology | 33 | 5 | 6.6 |
| Specialty | 5y total | Last 12mo | Unique sponsors |
|---|---|---|---|
| Orthopedic | 2933 | 419 | 696 |
| Radiology | 2772 | 461 | 959 |
| General, Plastic Surgery | 2538 | 370 | 1295 |
| Cardiovascular | 2232 | 373 | 863 |
| General Hospital | 1665 | 155 | 862 |
| Dental | 1541 | 227 | 692 |
| Gastroenterology, Urology | 1365 | 255 | 551 |
| Neurology | 1183 | 198 | 590 |
| Physical Medicine | 565 | 105 | 360 |
| Anesthesiology | 538 | 97 | 317 |
| Obstetrics/Gynecology | 522 | 91 | 278 |
| Microbiology | 490 | 102 | 146 |
| Clinical Chemistry | 407 | 58 | 154 |
| Unknown | 404 | 70 | 253 |
| Ophthalmic | 295 | 44 | 156 |
| Ear, Nose, Throat | 267 | 44 | 149 |
| Immunology | 134 | 20 | 57 |
| Hematology | 116 | 17 | 62 |
| Clinical Toxicology | 115 | 22 | 52 |
| Pathology | 47 | 9 | 33 |
Studies sponsored by the top 20 players above, last 5y. Sponsor name match via normalize_applicant() — coverage gaps possible.
| NCT | Title | Sponsor | Status | Phase | Started | N | Results |
|---|---|---|---|---|---|---|---|
| NCT07458243 | A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population | Boston Scientific Corporation | Not Yet Recruiting | — | 2026-10-31 | 60 | — |
| NCT07458217 | Combined CM and STN Stimulation for Motor Epilepsy | Boston Scientific Corporation | Not Yet Recruiting | NA | 2026-10-31 | 10 | — |
| NCT07564375 | MBA Early Feasibility Study | W.L.Gore & Associates | Not Yet Recruiting | NA | 2026-09-01 | 20 | — |
| NCT07276815 | OverStitch NXT Endoscopic Suture System | Boston Scientific Corporation | Not Yet Recruiting | NA | 2026-07-31 | 136 | — |
| NCT07619872 | KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance | Edwards Lifesciences | Not Yet Recruiting | — | 2026-06-30 | 250 | — |
| NCT07195708 | Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365') | Boston Scientific Corporation | Not Yet Recruiting | NA | 2026-06-30 | 144 | — |
| NCT07575269 | Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation | Boston Scientific Corporation | Recruiting | NA | 2026-06-12 | 571 | — |
| NCT06819865 | A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism | Boston Scientific Corporation | Not Yet Recruiting | — | 2026-05-30 | 30 | — |
| NCT07428564 | A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF | Biosense Webster, Inc. | Recruiting | NA | 2026-05-19 | 50 | — |
| NCT07279649 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE) | W.L.Gore & Associates | Recruiting | — | 2026-05-08 | 240 | — |
| NCT07216573 | The Continuity Study | Edwards Lifesciences | Recruiting | NA | 2026-05-07 | 188 | — |
| NCT07455747 | Real-World Treatment of Extracranial Carotid Artery Disease With the ENROUTE™ Transcarotid Neuroprotection System | Boston Scientific Corporation | Not Yet Recruiting | — | 2026-05-01 | 5,000 | — |
| NCT07015424 | Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass | Boston Scientific Corporation | Recruiting | NA | 2026-04-14 | 108 | — |
| NCT07062094 | Safety and Effectiveness of Orbera365™ Intragastric Balloon System | Boston Scientific Corporation | Recruiting | — | 2026-04-07 | 200 | — |
| NCT07523750 | A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation | Biosense Webster, Inc. | Recruiting | NA | 2026-04-02 | 466 | — |
| NCT07166133 | GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study | W.L.Gore & Associates | Recruiting | NA | 2026-03-02 | 125 | — |
| NCT07408141 | MiniMed Fit Payload Wear Study | Medtronic MiniMed, Inc. | Active Not Recruiting | — | 2026-02-19 | 175 | — |
| NCT07444320 | Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System | Boston Scientific Corporation | Recruiting | NA | 2026-02-12 | 200 | — |
| NCT07377487 | TheraSphere Japan Pre-Market Study | Boston Scientific Corporation | Recruiting | NA | 2026-01-22 | 51 | — |
| NCT07209852 | Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up | Boston Scientific Corporation | Recruiting | — | 2025-12-19 | 140 | — |
| NCT07190794 | RESCUE: Discontinuation of GLP-1 | Boston Scientific Corporation | Recruiting | — | 2025-12-17 | 150 | — |
| NCT07262255 | WATCHMAN FLX Pro European Registry | Boston Scientific Corporation | Recruiting | — | 2025-12-17 | 1,000 | — |
| NCT07187115 | A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation | Boston Scientific Corporation | Recruiting | NA | 2025-11-07 | 699 | — |
| NCT07190807 | Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control | Boston Scientific Corporation | Recruiting | NA | 2025-11-07 | 70 | — |
| NCT06762717 | FARAPULSE™ Pulsed Field Ablation System | Boston Scientific Corporation | Recruiting | — | 2025-10-23 | 500 | — |
| NCT07069738 | Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure | Boston Scientific Corporation | Recruiting | NA | 2025-10-22 | 850 | — |
| NCT07227532 | A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System | Biosense Webster, Inc. | Recruiting | NA | 2025-10-21 | 276 | — |
| NCT06959524 | AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions | Boston Scientific Corporation | Recruiting | NA | 2025-08-21 | 1,616 | — |
| NCT06808217 | A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation | Boston Scientific Corporation | Active Not Recruiting | — | 2025-07-30 | 550 | — |
| NCT06750146 | Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis | Boston Scientific Corporation | Suspended | NA | 2025-06-19 | 162 | — |
| NCT06735534 | Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System | Boston Scientific Corporation | Recruiting | NA | 2025-06-03 | 376 | — |
| NCT06872905 | Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease | W.L.Gore & Associates | Recruiting | — | 2025-05-30 | 158 | — |
| NCT06827262 | Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain | Boston Scientific Corporation | Recruiting | — | 2025-03-26 | 1,500 | — |
| NCT06510556 | Feasibility Study of the FARAFLEX Mapping and PFA System | Boston Scientific Corporation | Recruiting | NA | 2025-02-17 | 250 | — |
| NCT06174805 | AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE | Boston Scientific Corporation | Suspended | NA | 2025-02-11 | 67 | — |
| NCT06492174 | A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort | Boston Scientific Corporation | Active Not Recruiting | PHASE3 | 2024-10-07 | 20 | — |
| NCT06431815 | ADVENT Post Approval Study | Boston Scientific Corporation | Active Not Recruiting | — | 2024-09-25 | 228 | — |
| NCT06170606 | POLARx Post Approval Study (POLARx PAS) | Boston Scientific Corporation | Active Not Recruiting | NA | 2024-06-28 | 200 | — |
| NCT06170619 | Obsidio™ Conformable Embolic Registry | Boston Scientific Corporation | Completed | — | 2024-06-19 | 125 | — |
| NCT06192758 | Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device | Boston Scientific Corporation | Active Not Recruiting | NA | 2024-04-15 | 36 | — |
| NCT06250322 | A Multicenter, Observational, Single Arm Study of the TECNIS Presbyopia-correcting Intraocular Lens | Johnson & Johnson Surgical Vision, Inc. | Completed | — | 2024-04-10 | 307 | — |
| NCT06168942 | A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination | Biosense Webster, Inc. | Suspended | NA | 2024-02-19 | 1,500 | — |
| NCT05800743 | Evaluation of the GORE® Ascending Stent Graft | W.L.Gore & Associates | Enrolling By Invitation | NA | 2023-11-28 | 370 | — |
| NCT05063565 | TheraSphere With Durvalumab and Tremelimumab for HCC | Boston Scientific Corporation | Active Not Recruiting | PHASE2 | 2023-11-03 | 100 | — |
| NCT05686317 | ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System | Edwards Lifesciences | Active Not Recruiting | NA | 2023-04-01 | 100 | — |
| NCT05501873 | Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System | Boston Scientific Corporation | Active Not Recruiting | — | 2023-03-24 | 1,173 | — |
| NCT05526560 | Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve | Edwards Lifesciences | Active Not Recruiting | — | 2023-01-11 | 504 | — |
| NCT05565599 | An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation | Biosense Webster, Inc. | Active Not Recruiting | NA | 2022-10-21 | 58 | — |
| NCT05302063 | A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Painful Diabetic Peripheral Neuropathy (pDPN) | Boston Scientific Corporation | Completed | NA | 2022-09-22 | 28 | — |
| NCT04919980 | TVMR With the INNOVALVE System Trial - Early Feasibility Study | Edwards Lifesciences | Recruiting | NA | 2022-09-01 | 65 | — |
Papers from the top 20 players, last 5y, via author affiliation match.
| PMID | Title | Journal | Authors | Date | Why |
|---|---|---|---|---|---|
| 42149092 · DOI | Macrophage-Fibroblast Crosstalk Shapes Wound Repair Signaling In Vitro. | FASEB journal : official publication of the Federation of American Societies for Experimental Biology | Atcha H, Cahalan MD, Cano AD, Chang G et al. | 2026-05-31 | Sponsor |
| 42209817 · DOI | Post-hoc analysis of adverse events during the EPOCH trial: reconsidering dosimetry. | European journal of nuclear medicine and molecular imaging | Boucher E, Fowers K, Garin E, Harris W et al. | 2026-05-29 | Sponsor |
| 41910345 · DOI | Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for Acute Pulmonary Embolism. | The New England journal of medicine | Araszkiewicz A, Arora V, Asch FM, Barco S et al. | 2026-05-28 | Sponsor |
| 42201288 · DOI | Risk-Based Nurse-Managed Personalized Heart Failure Interventions: The ALLEVIATE-HF Trial. | Journal of the American College of Cardiology | Basuray A, Butler J, Dukes JW, Gerritse B et al. | 2026-05-27 | Sponsor |
| 42201276 · DOI | Arrhythmia Burden and Clinical Responses Under Continuous Monitoring in Heart Failure: Observations From the ALLEVIATE-HF Trial. | Journal of the American College of Cardiology | Amin A, Butler J, Dukes J, Gerritse B et al. | 2026-05-27 | Sponsor |
| 42208889 · DOI | IN.PACT AV Access Post-Approval Study of a Paclitaxel Drug-Coated Balloon for the Treatment of Dysfunctional Arteriovenous Dialysis Circuits. | Journal of vascular and interventional radiology : JVIR | Atkinson C, Chan M, Dermody M, Gallo V et al. | 2026-05-27 | Sponsor |
| 42203167 · DOI | Randomised Clinical Trials Comparing Cyanoacrylate Closure with Surgical Stripping and Endovenous Thermal Ablation for Chronic Venous Disease. | European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery | Ali A, Davies AH, Falvo N, Gibson K et al. | 2026-05-26 | Sponsor |
| 42185917 · DOI | Cost-effectiveness of intravascular ultrasound (IVUS) vs. angiography-guided revascularization in femoropopliteal occlusive disease. | Cost effectiveness and resource allocation : C/E | Alvarez L, Bretos-Azcona PE, Ruiz Gay-Pobes P | 2026-05-25 | Sponsor |
| 42191026 · DOI | Sarcopenia in Diabetes: A proposal on integrating muscle assessment and nutritional intervention in people living with diabetes. | Diabetes research and clinical practice | Aldahash R, Ballesteros-Pomar MD, Barazzoni R, Catino MA et al. | 2026-05-25 | Sponsor |
| 42190924 · DOI | Subcutaneous ICD Therapy in Patients with Monomorphic Ventricular Tachycardia: Arrhythmia Recurrence, Shock Rate, and Management Strategies. | Heart rhythm | Bambagioni G, Bianchi V, Biffi M, Bisignani A et al. | 2026-05-25 | Sponsor+KW |
Monthly publication count for the top-20 sponsor cohort, last 5y. Cohort-wide signal — a falling tail can indicate cohort consolidation, lab closures, or paper-pipeline drying up.
| Month | Publications | Count |
|---|---|---|
| 2026-05 | 10 |
Recent bioRxiv + medRxiv preprints matching broad medtech keywords. Watch for trends 6-18 months ahead of PubMed.
| DOI / Platform | Title | Corresponding author + institution | Category | Posted | Peer-reviewed? |
|---|---|---|---|---|---|
|
medrxiv
10.64898/2026.05.29.26354409
|
Sensitive Glioma Detection and Recurrence Monitoring Using a Machine Learning Model Based on Circulating Monocytes | — | oncology | 2026-06-01 | Published |
|
medrxiv
10.64898/2026.05.22.26353890
|
Real-world impact of a sepsis early detection model integrated into clinical workflow: a quasi-experimental study | — | health informatics | 2026-06-01 | Published |
|
medrxiv
10.64898/2026.05.27.26354252
|
Using artificial intelligence for radiotherapy clinical trial quality assurance: analysis of a multi-institutional clinical trial for neurovascular-sparing prostate stereotactic ablative radiotherapy | — | health informatics | 2026-05-29 | Published |
|
biorxiv
10.64898/2026.05.20.724677
|
Biofilm dispersion in Enterococcus faecalis is mediated by nutrient step-change and intra-species signaling |
Peter T McKenney
Albany Medical College
|
microbiology | 2026-05-21 | Published |
|
medrxiv v2
10.64898/2026.02.24.26347028
|
Evidence of Unreliable Data and Poor Data Provenance in Clinical Prediction Model Research and Clinical Practice |
Alexander D Gibson
Queensland University of Technology
|
health systems and quality improvement | 2026-05-19 | Published |
|
medrxiv v3
10.64898/2026.05.13.26353099
|
Effectiveness of RMSSD-Based Adaptive Music Therapy (Skitii) in Reducing Treatment-Related Anxiety in Head and Neck Cancer Patients: Protocol for a Randomized Controlled Trial |
Prabha Adhikari
Department of Geriatrics, Yenepoya Medical College Hospital, Yenepoya (Deemed to be University), Mangalore, Karnataka, I…
|
oncology | 2026-05-18 | Published |
|
medrxiv v2
10.64898/2026.05.13.26353099
|
Effectiveness of RMSSD-Based Adaptive Music Therapy (Skitii) in Reducing Treatment-Related Anxiety in Head and Neck Cancer Patients: Protocol for a Randomized Controlled Trial |
Prabha Adhikari
Department of Geriatrics, Yenepoya Medical College Hospital, Yenepoya (Deemed to be University), Mangalore, Karnataka, I…
|
oncology | 2026-05-16 | Published |
FDA AdComm meetings scheduled within the next 12 months, sourced from Federal Register notices. Regulatory inflection signals — committee discussions often precede class-level enforcement or guidance changes.
| Meeting date | Committee | Title / topic | Device refs | FR notice |
|---|---|---|---|---|
|
2026-06-18
posted 2026-05-22
|
Vaccines and Related Biological Products Advisory Committee |
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) Manufactured by Moderna TX Inc.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
|
— | 2026-10321 |
|
2026-07-23
posted 2026-04-16
|
Pharmacy Compounding Advisory Committee |
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
|
— | 2026-07361 |