medical-devices

Documents about medical-devices

• Comparison of Rates of Safety Issues and Reporting of Trial Outcomes for Medical Devices Approved in the European Union and United States: Cohort Study#643623Harvard DASH
• Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015–20): a comparative analysis#679480OpenAlex
• Solutions for Mitigating Cybersecurity Risks Caused by Legacy Software in Medical Devices: A Scoping Review#686301OpenAlex
• Validation of cueStim for Reduction of Freezing of Gait in Parkinson's Disease#860916ClinicalTrials.gov
• Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain#868766ClinicalTrials.gov
• Comparative Study Of Safety And Efficacy Of The SUPERA® Nitinol Stent - Iliac Artery#904308ClinicalTrials.gov
• 21 CFR Part 864 — Hematology and Pathology Devices#506900Code of Federal Regulations (eCFR)
• 21 CFR Part 866 — Immunology and Microbiology Devices#506901Code of Federal Regulations (eCFR)
• 21 CFR Part 884 — Obstetrical and Gynecological Devices#506910Code of Federal Regulations (eCFR)
• 21 CFR Part 874 — Ear, Nose, and Throat Devices#506905Code of Federal Regulations (eCFR)
• 21 CFR Part 878 — General and Plastic Surgery Devices#506907Code of Federal Regulations (eCFR)
• Three Decades of Food and Drug Administration Authorizations of Artificial Intelligence/Machine Learning-Enabled Medical Devices: Persistent Specialty Concentration and the Care-Delivery Gap (1995-2025).#452845NCBI PubMed Central
• Accuracy Analysis of MPX5050DP, MLX90614, and GY-MAX30102 Sensors Compared to Standard Medical Devices for Recording Four Vital Signs of Patients#474179UMS ETD-db
• TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR#830548ClinicalTrials.gov
• Open-Label Test of the HM242 Medical Devices to Evaluate Safety and Local Tolerability#908986ClinicalTrials.gov
• Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum#967434ClinicalTrials.gov
• 21 CFR Part 862 — Clinical Chemistry and Clinical Toxicology Devices#506899Code of Federal Regulations (eCFR)
• 21 CFR Part 880 — General Hospital and Personal Use Devices#506908Code of Federal Regulations (eCFR)
• Études de faisabilité précoce en Europe: enjeux, perspectives et impacts attendus pour l'évaluation clinique des dispositifs médicaux (Early feasibility studies in Europe: Challenges, perspectives, and expected impacts on the clinical evaluation of medical devices)#990475Zenodo (CERN)
• Pilot Study Person-centred Tablet Intervention#800900ClinicalTrials.gov
• SPIRIT FIRST Clinical Trial of the Abbott Vascular XIENCE V® Everolimus Eluting Coronary Stent System#803657ClinicalTrials.gov
• ENHANCE-Efficacy of the Presence of Right Ventricular Apical Pacing Induced Ventricular Dyssynchrony as a Guiding Parameter for Biventricular Pacing in Patients With Bradycardia and Normal Ejection Fraction#830833ClinicalTrials.gov
• XIENCE V: SPIRIT WOMEN#876445ClinicalTrials.gov
• Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study#905782ClinicalTrials.gov
• Flow-diverting Devices for the Treatment of Middle Cerebral Artery Bifurcation Aneurysms#909884ClinicalTrials.gov
• Absorb IV Randomized Controlled Trial#917994ClinicalTrials.gov
• ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe#813669ClinicalTrials.gov
• Persona IQ Cohort Study#829406ClinicalTrials.gov
• Evaluation of Plaque Removal Efficacy & Patient Acceptability of Knotted Floss Technique in Type II Gingival Embrasures#854990ClinicalTrials.gov
• Kinematic and Kinetic Effects of Orthotic Devices for Subjects With Stage II Posterior Tibial Tendon Dysfunction#855505ClinicalTrials.gov
• Ethical and Legal Implications of Remote Monitoring of Medical Devices#964754OpenAlex
• Evaluation of Ocular Biometry in PACD With Two Swept Source Optical Coherence Tomography Devices#968513ClinicalTrials.gov
• xDot Access Management System Early Feasibility Study#1007109ClinicalTrials.gov
• Romania – Mammography devices – Mamograf digital cu modul de tomosinteza — Centrul Medical de Diagnostic, Tratament Ambulatoriu si Medicina Preventiva - Bucuresti (ROU) · 1449000 RON#1021339EU TED (Tenders Electronic Daily)
• Validation of an updated French national tool for reporting pharmacist interventions for all healthcare products#471865HAL (France)
• Sweden – Miscellaneous medical devices and products – Digitala medicinskåp — Ale kommun (SWE) · 3000000 SEK#606207EU TED (Tenders Electronic Daily)
• Interventional Ventricular Assist System for PCI in CHIP Patients#834123ClinicalTrials.gov
• A Post-Market Assessment of the Safety and Performance of the TriClip™ System#839322ClinicalTrials.gov
• XIENCE 28 USA Study#875602ClinicalTrials.gov
• EffectivenesS of Additional X-ray PRotection dEviceS in Reducing Scattered Radiation in Radial interventiOn#859842ClinicalTrials.gov
• Aortic Valve Replacement With Trifecta(TM)#912257ClinicalTrials.gov
• Abbott Next Generation Drug Eluting Stent 48mm Study#982418ClinicalTrials.gov
• 21 CFR Part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices#506887Code of Federal Regulations (eCFR)
• Italy – Miscellaneous medical devices and products – Suturatrici meccaniche e trocar — Regione Toscana (ITA) · 179313268.64 EUR#655631EU TED (Tenders Electronic Daily)
• Current and potential uses of drones in healthcare delivery in sub-Saharan Africa: a rapid scoping review#684624Europe PMC
• Italy – Miscellaneous medical devices and products – CND T — IRCCS FONDAZIONE PASCALE (ITA) · 306600 EUR#782619EU TED (Tenders Electronic Daily)
• Italy – Miscellaneous medical devices and products – 24PRE004.1 - MATERIALE DI CONSUMO PER ELETTROBISTURI — ARCS (ITA) · 1985739.66 EUR#782625EU TED (Tenders Electronic Daily)
• Reduction of Inappropriate Implantable Cardioverter Defibrillator (ICD) Therapies in Primary Prevention Patients#826069ClinicalTrials.gov
• RISE: A Clinical Evaluation of the StarClose™ Vascular Closure System#902385ClinicalTrials.gov
• 21 CFR Part 803 — Medical Device Reporting#506885Code of Federal Regulations (eCFR)