medical-devices

Documents about medical-devices

• Regulatory status of herbal medicines in Latin America. New focus for marketing authorization of herbal medicines as medical devices#22636J-STAGE (Japan)
• Advances in Artificial Intelligence-Based Medical Devices for Healthcare Applications#130580Springer Nature OA
• Design and fabrication of thermoelectric generators for implantable medical devices#206925RosDok
• Overdiagnosis in atrial fibrillation screening with wearables.#302083PubMed
• Analysis of the challenges in ensuring robust and effective clinical evaluation of AI-based digital medical devices#312052HAL (France)
• BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF#460044ClinicalTrials.gov
• Challenges and Recommendations in Regulating AI Medical Devices in the European Union: A Scoping Review.#785628NCBI PubMed Central
• QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization#805817ClinicalTrials.gov
• The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System#810310ClinicalTrials.gov
• ABSORB Post-Approval Clinical Study#811000ClinicalTrials.gov
• Application of the "Haemoblock" in Pacemaker Patients#845771ClinicalTrials.gov
• Wearable Devices to Monitor Efficacy of Epidural Steroid Injection in Patients With Low Back Pain#849137ClinicalTrials.gov
• BM Shockwave Devices Clinical Study in Coronary Calcified Lesions#870826ClinicalTrials.gov
• Hong Kong and Taiwan HM3 PMS#980609ClinicalTrials.gov
• The Effectiveness of Using Interactive Devices for Home Exercise in Patients With Frozen Shoulder.#1047622ClinicalTrials.gov
• United States Food and Drug Administration Approval of Neurosurgical Devices: A 25-Year Review of Non-510(k) Pathway Trends#657819Cornell eCommons
• 21 CFR Part 814 — Premarket Approval of Medical Devices#506892Code of Federal Regulations (eCFR)
• International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension#148639ClinicalTrials.gov
• Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh.#334800NCBI PubMed Central
• Cybersecurity for Cardiac Implantable Electronic Devices#423229OpenAlex
• The value of qualitative research in randomized controlled trials involving drugs and medical devices: a systematic mapping review.#434041NCBI PubMed Central
• Study to Evaluate the Performance and Safety of ATF Implants and Lapé Médical Devices Implanted During Hip Arthroplasty#801659ClinicalTrials.gov
• Aveir DR i2i Study#810258ClinicalTrials.gov
• Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study#835282ClinicalTrials.gov
• An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device (bRIGHT)#850118ClinicalTrials.gov
• A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS)#887675ClinicalTrials.gov
• Comparison Study in Adult Surgical Patients of 5 Airway Devices#888556ClinicalTrials.gov
• A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems#913742ClinicalTrials.gov
• Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery#1032200ClinicalTrials.gov
• Medical Devices Excise Tax (MDET) — A Market-Specific VAT?#309804Scholarly Commons at Boston University School of Law
• 21 CFR Part 806 — Medical Devices; Reports of Corrections and Removals#506886Code of Federal Regulations (eCFR)
• Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS#801605ClinicalTrials.gov
• Multicenter International Trial Ring AnnulopLasty#839471ClinicalTrials.gov
• QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead#840660ClinicalTrials.gov
• PROLONG Prospective, Multi-center, Open-label, Post-market Study#842980ClinicalTrials.gov
• Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions#849471ClinicalTrials.gov
• CLEANer Aspiration for Pulmonary Embolism#852487ClinicalTrials.gov
• Comparative Study for the Evaluation of Two Medical Devices on the Treatment of Head Lice Infestation#906005ClinicalTrials.gov
• The landscape of artificial intelligence-enabled medical devices in the EU and the US intended for intensive care units.#30874NCBI PubMed Central
• DSTAN-Med: Dual-Channel Spatiotemporal Attention with Physiological Plausibility Filtering for False Data Injection Attack Detection in IoT-Based Medical Devices#187264arXiv CS
• United States v. Jackson: Clarifying the Scope of the Off-Label Use Privilege as Applied to the Reuse of Single-Use Medical Devices#226443DigitalCommons@UM Carey Law
• High-Sensitivity Non-Invasive Microwave Glucose Sensor with ZnO/CNT Composite Optimized by Deep Learning for Wearable Medical Devices.#438951NCBI PubMed Central
• Variation in Attribute Prioritization and Design of Discrete Choice Experiments Across Pharmaceuticals and Medical Devices Patient Preference: A Systematic Review.#615892NCBI PubMed Central
• ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices#800910ClinicalTrials.gov
• Triple Chamber Pacing in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients - TRICHAMPION STUDY#845224ClinicalTrials.gov
• Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER#852249ClinicalTrials.gov
• Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers#875049ClinicalTrials.gov
• Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation#883482ClinicalTrials.gov
• CardioMEMS HF System Real-World Evidence Post-Approval Study#909357ClinicalTrials.gov
• Effects of Photobiomodulation on Insomnia in the Elderly: Clinical Trials of Phototherapy Devices#909938ClinicalTrials.gov