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Context Brief
The U.S. medical-device market exhibits pronounced concentration among a handful of dominant players, yet structural vulnerabilities are surfacing that create actionable entry points for agile challengers. Medtronic, Inc. leads regulatory activity with over 1,896 submissions in the past five years, followed closely by Boston Scientific Corporation (1,688 submissions) and ABBOTT MEDICAL (1,172 submissions), collectively commanding the innovation pipeline across cardiovascular, neuromodulation, and diabetes segments. However, operational distress is evident: Boston Scientific has accumulated 113 Class I recalls and maintains 247 ongoing corrective actions over three years, while Medline Industries entities show 133 combined Class I recalls with 961 ongoing actions, signaling quality-system breakdowns that erode hospital confidence and create procurement gaps. Foreign manufacturers now capture 51.8% of clearances in the trailing twelve months, demonstrating that regulatory barriers have fallen and non-U.S. firms are successfully penetrating core hospital supply chains—a trend that validates the feasibility of an Indian entrant's ambitions while underscoring the urgency to move before this window narrows.
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 | 70 | 1826 | 75 | 3 | 70 | 9 | 36 | 2026-06-24 |
| Boston Scientific Corporation | US | 115 | 1573 | 444 | 131 | 368 | 14 | 45 | 2026-06-17 |
| ABBOTT MEDICAL | US | 54 | 1118 | 39 | 7 | 39 | 14 | 19 | 2026-06-17 |
| Medtronic Neuromodulation | US | 1 | 486 | 53 | 0 | 50 | 0 | 1 | 2021-08-23 |
| Biotronik, Inc. | US | 14 | 413 | 25 | 0 | 0 | 1 | 5 | 2026-05-01 |
| Edwards Lifesciences | US | 50 | 364 | 36 | 6 | 21 | 11 | 18 | 2026-06-26 |
| Medtronic Vascular | US | 4 | 327 | 18 | 5 | 9 | 0 | 3 | 2023-10-24 |
| W. L. Gore & Associates, Inc. | US | 5 | 275 | 25 | 0 | 22 | 0 | 2 | 2025-06-02 |
| DiaSorin, Inc. | US | 14 | 211 | 4 | 0 | 3 | 2 | 10 | 2026-06-04 |
| Biosense Webster, Inc. | US | 20 | 179 | 10 | 1 | 5 | 3 | 6 | 2026-02-20 |
| Alcon Laboratories, Inc. | US | 16 | 163 | 0 | 0 | 0 | 2 | 6 | 2026-02-13 |
| Abbott Laboratories | US | 16 | 156 | 33 | 0 | 29 | 1 | 11 | 2026-04-28 |
| Roche Molecular Systems, Inc. | US | 27 | 143 | 12 | 0 | 7 | 6 | 12 | 2026-05-15 |
| CooperVision, Inc. | US | 5 | 152 | 26 | 0 | 12 | 0 | 1 | 2024-01-25 |
| Siemens Healthcare Diagnostics, Inc. | US | 32 | 120 | 210 | 0 | 164 | 5 | 27 | 2026-02-27 |
| Ventana Medical Systems, Inc. | US | 4 | 130 | 4 | 0 | 4 | 0 | 3 | 2024-12-17 |
| Integra LifeSciences Corporation | US | 11 | 126 | 72 | 2 | 61 | 1 | 6 | 2025-10-08 |
| Medtronic Minimed | US | 10 | 124 | 51 | 3 | 51 | 6 | 4 | 2026-03-12 |
| Johnson & Johnson Surgical Vision, Inc. | US | 2 | 114 | 13 | 0 | 11 | 0 | 2 | 2023-04-14 |
| Abiomed, Inc. | US | 8 | 110 | 64 | 29 | 60 | 1 | 3 | 2025-10-08 |
| Abbott Vascular | US | 4 | 107 | 32 | 18 | 14 | 0 | 3 | 2022-06-30 |
| Abbott Molecular, Inc. | US | 11 | 100 | 30 | 5 | 21 | 2 | 9 | 2025-09-25 |
| ETHICON, Inc. | US | 13 | 96 | 26 | 0 | 22 | 6 | 6 | 2026-06-25 |
| Cochlear Americas | US | 5 | 100 | 0 | 0 | 0 | 0 | 3 | 2024-04-18 |
| Cordis US Corp | US | 4 | 99 | 22 | 15 | 22 | 0 | 4 | 2024-06-28 |
| Allergan | US | 2 | 100 | 1 | 0 | 0 | 0 | 2 | 2021-06-02 |
| Roche Diagnostics | US | 42 | 77 | 0 | 0 | 0 | 12 | 34 | 2026-06-12 |
| Smith & Nephew, Inc. | US | 72 | 51 | 97 | 0 | 82 | 3 | 26 | 2026-04-06 |
| Siemens Medical Solutions USA, Inc. | US | 156 | 3 | 231 | 16 | 145 | 17 | 16 | 2026-06-25 |
| Physio-Control, Inc. | US | 2 | 80 | 26 | 0 | 22 | 1 | 2 | 2025-10-14 |
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 | 247 | 247 | 46% | 2026-05-12 | United States |
| MEDLINE INDUSTRIES, LP - Northfield | 72 | 581 | 581 | 12% | 2025-07-25 | United States |
| Medline Industries, LP | 61 | 380 | 380 | 16% | 2026-05-28 | United States |
| Smiths Medical ASD Inc. | 61 | 126 | 126 | 48% | 2025-04-10 | United States |
| Baxter Healthcare Corporation | 40 | 173 | 173 | 23% | 2026-02-18 | United States |
| Olympus Corporation of the Americas | 37 | 263 | 263 | 14% | 2026-03-25 | United States |
| Philips Respironics, Inc. | 36 | 38 | 38 | 95% | 2026-03-02 | United States |
| Cardinal Health 200, LLC | 30 | 98 | 95 | 31% | 2026-02-27 | United States |
| Draeger, Inc. | 21 | 21 | 21 | 100% | 2026-05-07 | United States |
| PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 20 | 181 | 181 | 11% | 2026-05-18 | Netherlands |
| Abiomed, Inc. | 20 | 53 | 51 | 38% | 2026-05-22 | United States |
| GE Medical Systems China Co., Ltd. | 18 | 21 | 21 | 86% | 2025-11-14 | China |
| Datex-Ohmeda, Inc. | 17 | 17 | 17 | 100% | 2026-05-08 | United States |
| Siemens Medical Solutions USA, Inc | 16 | 67 | 67 | 24% | 2026-06-08 | United States |
| Fresenius Medical Care Holdings, Inc. | 16 | 40 | 40 | 40% | 2026-05-12 | United States |
| B Braun Medical Inc | 15 | 209 | 209 | 7% | 2026-05-06 | United States |
| AVID Medical, Inc. | 13 | 121 | 121 | 11% | 2026-03-13 | United States |
| ARROW INTERNATIONAL Inc. | 12 | 23 | 23 | 52% | 2026-04-10 | United States |
| Datascope Corp. | 12 | 22 | 22 | 55% | 2026-02-06 | United States |
| Vyaire Medical | 12 | 14 | 12 | 86% | 2025-04-10 | 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 | 22 | 5 | +340% | 27 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | 21 | 8 | +163% | 81 |
| OBP | Transcranial Magnetic Stimulator | Neurology | 13 | 5 | +160% | 17 |
| CAW | Generator, Oxygen, Portable | Anesthesiology | 13 | 5 | +160% | 25 |
| HGX | Pump, Breast, Powered | Obstetrics/Gynecology | 42 | 17 | +147% | 48 |
| IYE | Accelerator, Linear, Medical | Radiology | 16 | 7 | +129% | 41 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 12 | 6 | +100% | 23 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | 11 | 6 | +83% | 27 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | 12 | 7 | +71% | 50 |
| KGN | Wound Dressing With Animal-Derived Material(S) | Unknown | 17 | 10 | +70% | 37 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 23 | 14 | +64% | 51 |
| GXY | Electrode, Cutaneous | Neurology | 11 | 7 | +57% | 44 |
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | 28 | 19 | +47% | 48 |
| INI | Vehicle, Motorized 3-Wheeled | Physical Medicine | 19 | 13 | +46% | 35 |
| NUC | Lubricant, Personal | Obstetrics/Gynecology | 13 | 9 | +44% | 53 |
| Country | Clearances | Sponsors | Avg per sponsor |
|---|---|---|---|
| US | 1513 | 909 | 1.7 |
| CN | 557 | 353 | 1.6 |
| KR | 152 | 104 | 1.5 |
| DE | 112 | 69 | 1.6 |
| JP | 75 | 27 | 2.8 |
| IL | 75 | 55 | 1.4 |
| FR | 74 | 54 | 1.4 |
| CH | 68 | 30 | 2.3 |
| TW | 57 | 42 | 1.4 |
| CA | 52 | 40 | 1.3 |
| IT | 44 | 28 | 1.6 |
| GB | 40 | 36 | 1.1 |
| NL | 33 | 21 | 1.6 |
| ES | 28 | 21 | 1.3 |
| IE | 28 | 18 | 1.6 |
| AU | 27 | 23 | 1.2 |
| SE | 24 | 18 | 1.3 |
| BR | 22 | 13 | 1.7 |
| SG | 19 | 8 | 2.4 |
| IN | 18 | 16 | 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 | 49 | 2 | 24.5 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | Microbiology | 33 | 5 | 6.6 |
| Specialty | 5y total | Last 12mo | Unique sponsors |
|---|---|---|---|
| Orthopedic | 2986 | 409 | 708 |
| Radiology | 2829 | 455 | 977 |
| General, Plastic Surgery | 2583 | 364 | 1308 |
| Cardiovascular | 2273 | 369 | 878 |
| General Hospital | 1687 | 152 | 868 |
| Dental | 1574 | 234 | 704 |
| Gastroenterology, Urology | 1387 | 235 | 555 |
| Neurology | 1218 | 213 | 602 |
| Physical Medicine | 588 | 114 | 372 |
| Anesthesiology | 556 | 96 | 330 |
| Obstetrics/Gynecology | 538 | 101 | 285 |
| Microbiology | 498 | 93 | 150 |
| Unknown | 417 | 74 | 259 |
| Clinical Chemistry | 415 | 60 | 155 |
| Ophthalmic | 299 | 43 | 158 |
| Ear, Nose, Throat | 274 | 44 | 153 |
| Immunology | 137 | 21 | 57 |
| Hematology | 119 | 17 | 63 |
| Clinical Toxicology | 115 | 20 | 52 |
| Pathology | 47 | 7 | 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 |
|---|---|---|---|---|---|---|---|
| NCT07639684 | Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D) | Boston Scientific Corporation | Not Yet Recruiting | NA | 2027-02-01 | 50 | — |
| NCT07458217 | Combined CM and STN Stimulation for Motor Epilepsy | Boston Scientific Corporation | Not Yet Recruiting | NA | 2026-10-31 | 10 | — |
| 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 | — |
| NCT07691931 | TBE Zone 0/1 PMS in Japan | W.L.Gore & Associates | Not Yet Recruiting | — | 2026-09-01 | 75 | — |
| NCT07564375 | MBA Early Feasibility Study | W.L.Gore & Associates | Not Yet Recruiting | NA | 2026-09-01 | 20 | — |
| NCT07527299 | A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation | Biosense Webster, Inc. | Recruiting | NA | 2026-08-05 | 920 | — |
| NCT07684313 | TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study) | Edwards Lifesciences | Not Yet Recruiting | — | 2026-08-01 | 75 | — |
| NCT07669727 | A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning. | Boston Scientific Corporation | Not Yet Recruiting | — | 2026-08-01 | 140 | — |
| NCT07276815 | OverStitch NXT Endoscopic Suture System | Boston Scientific Corporation | Not Yet Recruiting | NA | 2026-07-31 | 136 | — |
| NCT07466745 | Autus Valve Continued Access Study (CAS) | Edwards Lifesciences | Not Yet Recruiting | NA | 2026-07-30 | 36 | — |
| NCT07502599 | Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE) | Boston Scientific Corporation | Recruiting | — | 2026-07-01 | 40 | — |
| NCT07353710 | A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure | Boston Scientific Corporation | Not Yet Recruiting | NA | 2026-07-01 | 200 | — |
| NCT07035431 | Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area | Boston Scientific Corporation | Recruiting | NA | 2026-07-01 | 66 | — |
| NCT07455747 | Real-World Treatment of Extracranial Carotid Artery Disease With the ENROUTE™ Transcarotid Neuroprotection System | Boston Scientific Corporation | Not Yet Recruiting | — | 2026-07-01 | 5,000 | — |
| NCT07675161 | MiniMed Fit Payload Wear Pediatric Study | Medtronic MiniMed, Inc. | Recruiting | — | 2026-06-25 | 100 | — |
| NCT07619872 | KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance | Edwards Lifesciences | Recruiting | — | 2026-06-25 | 250 | — |
| NCT07349121 | OPTION-EMEA Clinical Trial | Boston Scientific Corporation | Recruiting | NA | 2026-06-18 | 500 | — |
| 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 | — |
| NCT07195708 | Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365') | Boston Scientific Corporation | Recruiting | NA | 2026-06-03 | 144 | — |
| 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 | — |
| NCT07537478 | Respiration Measured Via End-tidal CO2 and Spirometry Study (RESPI) | Boston Scientific Corporation | Recruiting | — | 2026-05-28 | 50 | — |
| 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 | — |
| 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 | — |
| NCT07429214 | A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF | Biosense Webster, Inc. | Recruiting | NA | 2026-03-23 | 50 | — |
| NCT07118358 | BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System | Biotronik, Inc. | Recruiting | NA | 2026-03-16 | 325 | — |
| 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. | Completed | — | 2026-02-19 | 159 | — |
| NCT07444320 | Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System | Boston Scientific Corporation | Recruiting | NA | 2026-02-12 | 200 | — |
| NCT07228117 | GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes | Medtronic MiniMed, Inc. | Recruiting | NA | 2026-02-02 | 400 | — |
| 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 | Terminated | — | 2025-12-17 | 18 | — |
| 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 | — |
| NCT07115953 | Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension | Medtronic Vascular | Recruiting | NA | 2025-09-22 | 130 | — |
| NCT06827990 | GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections | W.L.Gore & Associates | Recruiting | NA | 2025-09-22 | 112 | — |
| NCT07116525 | A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter | Biosense Webster, Inc. | Recruiting | NA | 2025-09-15 | 90 | — |
| 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 | — |
| NCT07120048 | Real World Data Collection on the INSPIRIS RESILIA Aortic Valve | Edwards Lifesciences | Recruiting | — | 2025-07-30 | 500 | — |
| NCT06964685 | Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock | Abiomed Inc. | Recruiting | — | 2025-07-10 | 350 | — |
| NCT06982235 | Stone and Laser Therapies Post-Market Study (SALT) | Boston Scientific Corporation | Recruiting | — | 2025-06-30 | 238 | — |
| NCT06750146 | Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis | Boston Scientific Corporation | Suspended | NA | 2025-06-19 | 162 | — |
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
10.64898/2026.07.15.26357432
|
Malaria Pre-screening Technology Using Artificial Intelligence (AI) |
Olive O. Ibeto
University of Lagos, Nigeria
|
infectious diseases | 2026-07-17 | Published |
|
biorxiv
10.64898/2026.07.09.737638
|
Development and Validation of Thalia: A High-ResolutionPediatric Computational Model of a 10-Month-Old Infant |
Alice Albrecht
UCSF
|
bioengineering | 2026-07-16 | Published |
|
medrxiv
10.64898/2026.07.14.26358062
|
Benchmarking Speech Recognition Models for Medical Consultations in Latin American Spanish: A Comparative Evaluation with Fine-Tuning |
Rodrigo M. Carrillo
Emory University
|
public and global health | 2026-07-16 | Published |
|
medrxiv
10.64898/2026.07.08.26357335
|
Uncertainty-Aware Deep Learning Automates Artifact Correction for Clinical Body Surface Gastric Mapping at Scale |
Gabriel Schamberg
Alimetry
|
gastroenterology | 2026-07-09 | Published |
|
biorxiv
10.64898/2026.07.02.736058
|
The role of EPS in the selective biosorption and desorption of REEs |
Memphis Hill
University of Alaska Anchorage
|
microbiology | 2026-07-03 | Published |
|
medrxiv v2
10.64898/2026.02.02.26345379
|
Deep Learning-Enabled Screening of Chronic Kidney Disease from Echocardiography |
David Ouyang
Kaiser Permanente
|
cardiovascular medicine | 2026-07-03 | Published |
|
medrxiv
10.64898/2026.06.26.26356684
|
Artificial Intelligence in Medical Imaging With Emphasis on Generative and Foundation-Based Methods: A Bibliometric Analysis of Global and United Kingdom Research, 2017-2025 |
Jatin Sridhar Naidu
University College London
|
radiology and imaging | 2026-06-29 | Published |
|
medrxiv
10.64898/2026.06.23.26356383
|
Multi-task artificial intelligence annotation of echocardiographic images: a retrospective multi-cohort study |
David Ouyang
Kaiser Permanente Santa Clara Medical Center
|
cardiovascular medicine | 2026-06-25 | Published |
|
medrxiv
10.64898/2026.06.22.26356223
|
Reducing stillbirth in high burden settings using biomarkers and ultrasound technologies: protocol for the multi-centre prospective iTECH cohort study |
Sam Ali
Department of Obstetrics and Gynecology, Makerere University Hospital, Makerere University, Kampala, Uganda.
|
obstetrics and gynecology | 2026-06-24 | Published |
|
biorxiv
10.64898/2026.06.19.733410
|
Soft silicone surface stiffening by oxidation upon deep UV treatment as characterized using nanoindentation |
Venkat Maruthamuthu
Old Dominion University
|
bioengineering | 2026-06-22 | Published |
|
medrxiv
10.64898/2026.06.19.26356088
|
Artificial Intelligence-Enabled Cardiac Function Estimation from Phone Videos of Echocardiograms |
David Ouyang
Division of Research, Kaiser Permanente Northern California
|
cardiovascular medicine | 2026-06-22 | Published |
|
medrxiv
10.64898/2026.06.16.26355767
|
Biomedical Capacity, Governance, and Health Security: A Dominican Republic Research Analysis of Stakeholder Perspectives |
Amado Alejandro Baez
Universidad Nacional Pedro Henríquez Ureña: Universidad Nacional Pedro Henriquez Urena
|
health policy | 2026-06-18 | Published |
|
biorxiv v2
10.1101/2024.10.28.620772
|
Immune Cell Attachment on Material Surface Promotes Bacterial Aggregation and Biofilms |
Siddharth Jhunjhunwala
Indian Institute of Science
|
bioengineering | 2026-06-08 | Published |
|
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 |
Gyorgy J. Simon
Center for Learning Health System Sciences, University of Minnesota; Institute for Health Informatics, University of Min…
|
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 |
|---|---|---|---|---|
|
2026-07-23
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 |
|
2026-07-29
posted 2026-06-29
|
Cellular, Tissue, and Gene Therapies Advisory Committee |
Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells)
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies 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.
|
— | 2026-13096 |
|
2026-07-30
posted 2026-07-08
|
Cellular, Tissue, and Gene Therapies Advisory Committee |
Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies 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.
|
— | 2026-13810 |