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Medical Devices: Evidence and Research
ISSN: 1179-1470
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Archive: Volume 14, 2021
Evaluation of Advanced Bimanual Skills in Novices Using the Wrist-Like FlexDex™ Articulating Laparoscopic Needle Holder in 2D and 3D Vision: A Randomised Trial
Motahariasl N, Farzaneh SB, Motahariasl S, Kokotkin I, Sousi S, Zargaran A, Zargaran D, Patel B
Medical Devices: Evidence and Research 2021, 14:469-480
Published Date: 30 December 2021
The Medical Device Unique Device Identifier as the Single Source of Truth in Healthcare Enterprises – Roadmap for Implementation of the Clinically Integrated Supply Chain
Tcheng JE, Nguyen MV, Brann HW, Clarke PA, Pfeiffer M, Pleasants JR, Shelton GW, Kelly JF
Medical Devices: Evidence and Research 2021, 14:459-467
Published Date: 24 December 2021
Mobile Cardiac Outpatient Telemetry Patch vs Implantable Loop Recorder in Cryptogenic Stroke Patients in the US – Cost-Minimization Model
Medic G, Kotsopoulos N, Connolly MP, Lavelle J, Norlock V, Wadhwa M, Mohr BA, Derkac WM
Medical Devices: Evidence and Research 2021, 14:445-458
Published Date: 18 December 2021
A Cadaver-Based Biomechanical Evaluation of a Novel Posterior Approach to Sacroiliac Joint Fusion: Analysis of the Fixation and Center of the Instantaneous Axis of Rotation
Sayed D, Amirdelfan K, Naidu RK, Raji OR, Falowski S
Medical Devices: Evidence and Research 2021, 14:435-444
Published Date: 17 December 2021
A New Prototype of Smart Wearable Monitoring System Solution for Alzheimer’s Patients
Al-Naami B, Abu Owida H, Abu Mallouh M, Al-Naimat F, Agha M, Al-Hinnawi AR
Medical Devices: Evidence and Research 2021, 14:423-433
Published Date: 2 December 2021
Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care
Wilson NA, Tcheng JE, Graham J, Drozda JP Jr
Medical Devices: Evidence and Research 2021, 14:411-421
Published Date: 30 November 2021
Analysis of the Regulatory, Legal, and Medical Conditions for the Prescription of Mobile Health Applications in the United States, The European Union, and France
Hassanaly P, Dufour JC
Medical Devices: Evidence and Research 2021, 14:389-409
Published Date: 24 November 2021
Less Complexity in Hemodialysis Machines Reduces Time and Physical Load for Operator Actions
Gründler U, Ekesbo E, Löwe M, Gauly A
Medical Devices: Evidence and Research 2021, 14:379-387
Published Date: 17 November 2021
Formative Study on the Wearability and Usability of a Large-Volume Patch Injector
Lange J, Schneider A, Jordi C, Lau M, Disher T
Medical Devices: Evidence and Research 2021, 14:363-377
Published Date: 16 November 2021
Test–Retest Reliability of the Balance Tracking System Modified Clinical Test of Sensory Integration and Balance Protocol Across Multiple Time Durations
Goble DJ, Conner NO, Nolff MR, Haworth JL, Kendall BJ
Medical Devices: Evidence and Research 2021, 14:355-361
Published Date: 15 November 2021
Barriers to Uptake of Insulin Technologies and Novel Solutions
Pauley ME, Berget C, Messer LH, Forlenza GP
Medical Devices: Evidence and Research 2021, 14:339-354
Published Date: 12 November 2021
An Absorbing Improvement for Space Infection Decompression: A Novel Drainage Device
Bharath A, Madabhushi SSC
Medical Devices: Evidence and Research 2021, 14:327-337
Published Date: 9 November 2021
To Investigate the Effect of Targeted Overdilation in Balloon-Expandable Stents
Wong J, Backer E, Keenan JC, Dincer HE, Cho RJ
Medical Devices: Evidence and Research 2021, 14:321-325
Published Date: 27 October 2021
Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485)
Kheir O, Smedts S, Jacoby A, Verwulgen S
Medical Devices: Evidence and Research 2021, 14:313-319
Published Date: 15 October 2021
Digital Planning and Manufacturing of Maxillary Skeletal Expander for Patients with Thin Palatal Bone
Cantarella D, Karanxha L, Zanata P, Moschik C, Torres A, Savio G, Del Fabbro M, Moon W
Medical Devices: Evidence and Research 2021, 14:299-311
Published Date: 7 October 2021
Invention and Pilot Study of the Efficacy and Safety of the SUPRAtube Device in Continuous Supraglottic Aspiration for Intubated and Mechanically Ventilated Patients
Ramírez-Sarmiento A, Aya O, Cáceres-Rivera D, Reyes CF, Espitia A, Pizarro C, Gea J, Castillo VR, Orozco-Levi M
Medical Devices: Evidence and Research 2021, 14:287-297
Published Date: 5 October 2021
Programmed Multi-Level Ventilation: A Strategy for Ventilating Non-Homogenous Lungs
Depta F, Torok P, Reeves V, Gentile M
Medical Devices: Evidence and Research 2021, 14:277-285
Published Date: 21 September 2021
Bare Foot and In-shoe Plantar Pressure in Diabetic Males and Females – Is There Difference?
Altayyar SS
Medical Devices: Evidence and Research 2021, 14:271-276
Published Date: 15 September 2021
Options for Intraoperative Repair of a Cut Pilot Balloon on the Endotracheal Tube
Owusu-Bediako K, Turner III H, Syed O, Tobias J
Medical Devices: Evidence and Research 2021, 14:265-269
Published Date: 3 September 2021
A Biologic Surgical Implant in Complex Abdominal Wall Repair: 3-Year Follow-Up Results of a Multicentric Prospective Study
Gossetti F, Zuegel N, Giordano P, Pullan R, Schuld J, Delrio P, Montorsi M, van Kerschaver O, Lemaitre J, Griffiths B, D'Amore L
Medical Devices: Evidence and Research 2021, 14:257-264
Published Date: 25 August 2021
Satisfaction with an In-House Nasal Foreign Body Removal Manikin: A Randomized Controlled Trial
Pitathawatchai P, Anuntaseree S, Yuenyongviwat V
Medical Devices: Evidence and Research 2021, 14:249-256
Published Date: 20 August 2021
Safety of Medical Devices in Poland – Analysis of Withdrawn and Suspended Certificates of Compliance
Patryn R, Zagaja A, Drozd M
Medical Devices: Evidence and Research 2021, 14:239-247
Published Date: 26 July 2021
Bone Conduction Stimulated VEMP Using the B250 Transducer
Fredén Jansson KJ, Håkansson B, Reinfeldt S, Persson AC, Eeg-Olofsson M
Medical Devices: Evidence and Research 2021, 14:225-237
Published Date: 8 July 2021
Characteristics of a New Device for Intubation Through a Laryngeal Mask Airway Over a Flexible Endoscope
Vivian VH, Pardon TL, Vivian S, Van Zundert A
Medical Devices: Evidence and Research 2021, 14:217-223
Published Date: 6 July 2021
Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants: 24-Month Follow-Up
Patel V, Kovalsky D, Meyer SC, Chowdhary A, LaCombe J, Lockstadt H, Techy F, Langel C, Limoni R, Yuan P, Kranenburg A, Cher D, Tender G
Medical Devices: Evidence and Research 2021, 14:211-216
Published Date: 29 June 2021
Efficacy of Intraoperative Hemodynamic Optimization Using FloTrac/EV1000 Platform for Early Goal-Directed Therapy to Improve Postoperative Outcomes in Patients Undergoing Coronary Artery Bypass Graft with Cardiopulmonary Bypass: A Randomized Controlled Trial
Tribuddharat S, Sathitkarnmanee T, Ngamsangsirisup K, Nongnuang K
Medical Devices: Evidence and Research 2021, 14:201-209
Published Date: 28 June 2021
An Open, Uncontrolled Pilot Study on 12-Week Use of VagiVital for Treatment of Vulvovaginal Atrophy in Breast Cancer Patients Undergoing Adjuvant Aromatase-Inhibitor Therapy
Jonasson AF, Åstrom M
Medical Devices: Evidence and Research 2021, 14:193-200
Published Date: 25 June 2021
User-Centered Design: Developing the RELI Delivery System – a Low-Cost, Non-Electric, Pneumatic Infusion Pump
Abu-Haydar E, Katuntu D, Bauer J, Wollen A, Eisenstein M, Sherman-Konkle J, Roche A, Ruffo M
Medical Devices: Evidence and Research 2021, 14:185-192
Published Date: 24 June 2021
Evaluation of Cost, Payments, Healthcare Utilization, and Perioperative and Post-Operative Outcomes of Patients Treated with Posterior Lumbar Spinal Surgery Using Open versus Minimally Invasive Surgical Approaches
Holy CE, Corso KA, Bowden DE, Erb MJ, Ruppenkamp JR, Coombs S, Pracyk JB
Medical Devices: Evidence and Research 2021, 14:173-183
Published Date: 15 June 2021
Device for Controlling Stimulus Self-Application During Autonomic Nervous System Tests
Żyliński M, Niewiadomski W, Cybulski G, Gąsiorowska A
Medical Devices: Evidence and Research 2021, 14:165-172
Published Date: 1 June 2021
Avitene™ Microfibrillar Collagen Hemostat for Adjunctive Hemostasis in Surgical Procedures: A Systematic Literature Review
Cziperle DJ
Medical Devices: Evidence and Research 2021, 14:155-163
Published Date: 1 June 2021
A Novel Non-Invasive Device for the Assessment of Central Venous Pressure in Hospital, Office and Home
Marcelli E, Cercenelli L, Bortolani B, Marini S, Arfilli L, Capucci A, Plicchi G
Medical Devices: Evidence and Research 2021, 14:141-154
Published Date: 13 May 2021
Thermographic Assessment of Reperfusion Profile Following Using a Tourniquet in Total Knee Arthroplasty: A Prospective Observational Study
Alisi M, Al-Ajlouni J, Ibsais MK, Obeid Z, Hammad Y, Alelaumi A, Al-Saber M, Abuasbeh O, Abuhajleh F
Medical Devices: Evidence and Research 2021, 14:133-139
Published Date: 10 May 2021
A New Device for Measuring Abdominal Wall Tension and Its Value in Screening Abdominal Infection
Tang H, Liu D, Guo Y, Zhang H, Li Y, Peng X, Wang Y, Jiang D, Zhang L, Wang Z
Medical Devices: Evidence and Research 2021, 14:119-131
Published Date: 22 April 2021
Evaluation of the Accuracy of a Video and AI Solution to Measure Lower Leg and Foot Volume
Chausiaux O, Williams G, Nieznański M, Bagdu A, Downer P, Keyser M, Husheer S
Medical Devices: Evidence and Research 2021, 14:105-118
Published Date: 13 April 2021
Clinical Factors Associated with High Glycemic Variability Defined by Coefficient of Variation in Patients with Type 2 Diabetes
Gómez AM, Henao-Carillo DC, Taboada L, Fuentes O, Lucero O, Sanko A, Robledo MA, Muñoz O, Rondón M, García-Jaramillo M, León-Vargas F
Medical Devices: Evidence and Research 2021, 14:97-103
Published Date: 31 March 2021
Association of Complications with Healthcare Utilization and Hospital-Borne Costs Among Patients Undergoing Open Low Anterior Resection Using Curved Cutter Staplers
Rai P, Johnston SS, Chaudhuri R, Naoumtchik E, Pollack E
Medical Devices: Evidence and Research 2021, 14:87-95
Published Date: 31 March 2021
Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results [Corrigendum]
Christoffel L, Römer T, Schiermeier S
Medical Devices: Evidence and Research 2021, 14:85-86
Published Date: 15 March 2021
Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results
Christoffel L, Römer T, Schiermeier S
Medical Devices: Evidence and Research 2021, 14:77-84
Published Date: 3 March 2021
Real-World Outcomes of Patients Undergoing Open Colorectal Surgery with Wound Closure Incorporating Triclosan-Coated Barbed Sutures: A Multi-Institution, Retrospective Database Study
Johnson BH, Rai P, Jang SR, Johnston SS, Chen BPH
Medical Devices: Evidence and Research 2021, 14:65-75
Published Date: 24 February 2021
Putting Patients Ahead by Leaving Nothing Behind: An Emerging Treatment Paradigm in Minimally Invasive Surgical Therapy for Benign Prostatic Hyperplasia
McVary KT, Chughtai B, Miller LE, Bhattacharyya SK, Dornbier RA, Elterman DS
Medical Devices: Evidence and Research 2021, 14:59-64
Published Date: 22 February 2021
Challenges Associated with the Safety Signal Detection Process for Medical Devices
Pane J, Verhamme KMC, Villegas D, Gamez L, Rebollo I, Sturkenboom MCJM
Medical Devices: Evidence and Research 2021, 14:43-57
Published Date: 24 February 2021
Advanced Capnography Sampling Lines May Improve Patient Comfort and Compliance
Blonder Y, Mazor E, Jew K
Medical Devices: Evidence and Research 2021, 14:37-42
Published Date: 18 February 2021
Compatibility and Safety Implications Associated with Interfacing Medical Devices in Neonatal Respiratory Care: A Case Example Using the Inhaled Nitric Oxide Delivery System
DeWitt AL, Acker J, Larkin TA, Potenziano JL, Schmidt JM
Medical Devices: Evidence and Research 2021, 14:27-35
Published Date: 17 February 2021
Intramedullary Nail Breakage and Mechanical Displacement in Patients with Proximal Femoral Fractures: A Commercial and Medicare Supplemental Claims Database Analysis
Chitnis AS, Ray B, Sparks C, Grebenyuk Y, Vanderkarr M, Holy CE
Medical Devices: Evidence and Research 2021, 14:15-25
Published Date: 9 February 2021
Comparative in-vitro Study of the Trachospray, a New Device for Topical Anaesthesia of the Upper Airway
van Geffen GJ, Markerink H, van Barneveld M, Verhoeven F, Scheffer GJ, Bruhn J
Medical Devices: Evidence and Research 2021, 14:9-14
Published Date: 22 January 2021
Rationale for Use of an FDA-Cleared Delivery System for Administration of Inhaled Nitric Oxide in Patients Undergoing Magnetic Resonance Imaging
Salas M, Potenziano JL, Acker J
Medical Devices: Evidence and Research 2021, 14:1-7
Published Date: 7 January 2021