medical-devices

Documents about medical-devices

• SHIELD II Clinical Investigation#917431ClinicalTrials.gov
• The HERCULES Trial - A Safety and Effectiveness Study of the Herculink Elite Renal Stent to Treat Renal Artery Stenosis#350038ClinicalTrials.gov
• Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure#353356ClinicalTrials.gov
• Stepping Up: A Trial of Activity Monitoring Devices in Patients Undergoing Autologous Stem Cell Transplant#828646ClinicalTrials.gov
• TOCCATA - Touch+™ for Catheter Ablation#968601ClinicalTrials.gov
• A Review of Biomedical Devices: Classification, Regulatory Guidelines, Human Factors, Software as a Medical Device, and Cybersecurity#671743OpenAlex
• A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain#892477ClinicalTrials.gov
• A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study#1009989ClinicalTrials.gov
• Cardiovascular Systems Inc. (CSI) pVAD First in Human Study#1031055ClinicalTrials.gov
• ACCULINK for Revascularization of Carotids in High Risk Patients "The ARCHeR Trial"#1044394ClinicalTrials.gov
• A Neuro-Cognitive Quantum Architecture for Trustworthy AI in Ultra-Scarce Medical Environments#228814Springer Nature OA
• Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)#802188ClinicalTrials.gov
• Comparison of Two Over the Counter Intravaginal Devices for the Treatment of Stress Urinary Incontinence#854874ClinicalTrials.gov
• XIENCE V® EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery#868763ClinicalTrials.gov
• Skin Tolerance of Medical Devices for Diabetes Monitoring and Treatment in Children With Type 1 Diabetes#895983ClinicalTrials.gov
• Tunneled Hemodialysis Catheters as Permanent Vascular Access: Evaluating One-year Patency Rate and Affecting Factors#1010558ClinicalTrials.gov
• Protecting Radiology Data and Devices Against Cybersecurity Threats: A Joint White Paper of the American College of Radiology (ACR) and Society for Imaging Informatics in Medicine (SIIM).#136082PubMed
• Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices and in vitro diagnostics: a scoping review.#354651NCBI PubMed Central
• LIFE-BTK Randomized Controlled Trial#860261ClinicalTrials.gov
• CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass#860362ClinicalTrials.gov
• Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead#873853ClinicalTrials.gov
• Predict Early Cognitive Changes in a Healthy Elderly Population by Passively Recording Sensor Data From Mobile Devices#875055ClinicalTrials.gov
• STEM-Parkinson's Disease#967396ClinicalTrials.gov
• Interventional Left Ventricular Assist System for PCI in CHIP Patients#970028ClinicalTrials.gov
• Automatic External Defibrillation Monitoring in Cardiac Arrest#1009224ClinicalTrials.gov
• 21 CFR Part 868 — Anesthesiology Devices#506902Code of Federal Regulations (eCFR)
• 21 CFR Part 870 — Cardiovascular Devices#506903Code of Federal Regulations (eCFR)
• 21 CFR Part 872 — Dental Devices#506904Code of Federal Regulations (eCFR)
• 21 CFR Part 882 — Neurological Devices#506909Code of Federal Regulations (eCFR)
• 21 CFR Part 886 — Ophthalmic Devices#506911Code of Federal Regulations (eCFR)
• 21 CFR Part 888 — Orthopedic Devices#506912Code of Federal Regulations (eCFR)
• 21 CFR Part 892 — Radiology Devices#506914Code of Federal Regulations (eCFR)
• 21 CFR Part 895 — Banned Devices#506915Code of Federal Regulations (eCFR)
• A Security Framework for Pacemaker Lead Failure: Anomaly Detection System and Failsafe Policy Considerations#353522DigitalCommons@CalPoly
• STEM-PD Open Label Extension (OLE)#800438ClinicalTrials.gov
• Proactive Risk Evaluation for Cardiac Implantable Electronic Device Strategy Using AI-ECG#828516ClinicalTrials.gov
• Accuracy of Continuous Glucose Monitoring in Patients With Diabetes. A Prospective Observational Study#870145ClinicalTrials.gov
• Remote Device Interrogation In The Emergency Department#872458ClinicalTrials.gov
• WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease#886229ClinicalTrials.gov
• Validation Study in Healthy Female Volunteers: A Comparison of Two Neurotech Vital Devices Set up to Provide Different Types of Electrical Stimulation#901500ClinicalTrials.gov
• Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay#904939ClinicalTrials.gov
• 21 CFR Part 876 — Gastroenterology-Urology Devices#506906Code of Federal Regulations (eCFR)
• 21 CFR Part 890 — Physical Medicine Devices#506913Code of Federal Regulations (eCFR)
• AI in medical devices: regulatory challenges and the path forward#161427Springer Nature OA
• Cybersecurity vulnerabilities in medical devices: a complex environment and multifaceted problem#199623OpenAlex
• SoK: Security and Privacy in Implantable Medical Devices and Body Area Networks#199707OpenAlex
• Innovative Clinical Trial Approach for Evaluating Digital Medical Devices Under European Fast‐Track Regulatory Frameworks#235156HAL (France)
• In vitro diagnostic medical devices used for the quantitative detection of HIV-1 nucleic acid#267429WHO IRIS
• Proactive adoption of generative artificial intelligence (AI) in the operations of Japan's Pharmaceuticals and Medical Devices Agency (PMDA): Current initiatives, governance, and future perspectives.#323225NCBI PubMed Central
• XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)#432852ClinicalTrials.gov