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Journal Articles

Regulatory Challenges in AI/ML-Enabled Medical Devices: A Scoping Review and Conceptual Framework

Sanju Kaladharan, Dhanya Manayath, Rejikumar Gopalakrishnan
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Review Articles
J. Med. Devices. December 2024, 18(4): 040801.
Paper No: MED-24-1065
https://doi.org/10.1115/1.4066280
Published Online: September 19, 2024
View Article titled, Regulatory Challenges in AI/ML-Enabled Medical Devices: A Scoping Review and Conceptual Framework
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Topics: Artificial intelligence, Computer security, Health care, Machine learning, Medical devices, Sustainability, Economics , Regulations, Safety, Health systems
Includes: Supplementary data
Journal Articles

Modeling and Admittance Control of a Piezoactuated Needle Insertion Device for Safe Puncture of Spinal Membranes

Yuzhou Duan, Jie Ling, Yuchuan Zhu
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Technical Briefs
J. Med. Devices. September 2024, 18(3): 034501.
Paper No: MED-24-1037
https://doi.org/10.1115/1.4066045
Published Online: August 1, 2024
View Article titled, Modeling and Admittance Control of a Piezoactuated Needle Insertion Device for Safe Puncture of Spinal Membranes
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Topics: Control equipment, Friction, Mechanical admittance, Membranes, Modeling, Needles, Safety, Stick-slip, Errors, Robotics
Journal Articles

A Portable, Vacuum-Operated, and Purely Mechanical Device for Extracting Feces by Suction to Cure Chronic Anal Fissures

Riaz Ur Rehman Mohammed, Vedad Bassari, Richard Rasmussen, Benjamin S. Terry
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. March 2023, 17(1): 011005.
Paper No: MED-22-1076
https://doi.org/10.1115/1.4056251
Published Online: December 12, 2022
View Article titled, A Portable, Vacuum-Operated, and Purely Mechanical Device for Extracting Feces by Suction to Cure Chronic Anal Fissures
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Topics: Catheters, Flow (Dynamics), Suction, Testing, Vacuum, Safety, Pressure, Leakage
Journal Articles

Comanipulation Robotic Platform for Spine Surgery With Exteroceptive Visual Coupling: Development and Experimentation

Alizée Koszulinski, Juan Sandoval, Tanguy Vendeuvre, Saïd Zeghloul, Med Amine Laribi
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. December 2022, 16(4): 041002.
Paper No: MED-21-1232
https://doi.org/10.1115/1.4054550
Published Online: June 16, 2022
View Article titled, Comanipulation Robotic Platform for Spine Surgery With Exteroceptive Visual Coupling: Development and Experimentation
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Topics: Drilling, Robotics, Robots, Surgery, Safety, Orthopedics, Stiffness, Trajectories (Physics)
Journal Articles

Generating Appropriate and Reliable Evidence for Value Assessment of Medical Devices: An ISPOR Medical Devices and Diagnostics Special Interest Group Report

Nneka C. Onwudiwe, Richard Charter, Bruce Gingles, Payam Abrishami, Henry Alder, Ameet Bahkai, Diane Civic, Melodi Kosaner Kließ, Chantale Lessard, Carla L. Zema
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Expert View
J. Med. Devices. September 2022, 16(3): 034701.
Paper No: MED-20-1229
https://doi.org/10.1115/1.4053928
Published Online: April 12, 2022
View Article titled, Generating Appropriate and Reliable Evidence for Value Assessment of Medical Devices: An ISPOR Medical Devices and Diagnostics Special Interest Group Report
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Topics: Medical devices, Safety, Performance, Design
Journal Articles

Positive Pressure Testing Booths Development and Deployment in Response to the COVID-19 Outbreak

Kevin Aroom, Jiawei Ge, Lidia Al-Zogbi, Marcee White, Adrienne Trustman, Adena Greenbaum, Jason Farley, Axel Krieger
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. March 2022, 16(1): 011001.
Paper No: MED-21-1004
https://doi.org/10.1115/1.4052515
Published Online: February 3, 2022
View Article titled, Positive Pressure Testing Booths Development and Deployment in Response to the COVID-19 Outbreak
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Topics: Biomedicine, Design, Health care, Pressure, Pressure testing, Safety, Testing, Air conditioning, Particulate matter, Risk
Journal Articles

VEMERS UC: A Clinically Validated Emergency Mechanical Ventilator for COVID-19 and Postpandemic Use in Low Resource Communities

Luciano E. Chiang, Felipe A. Castro
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. September 2021, 15(3): 031008.
Paper No: MED-20-1151
https://doi.org/10.1115/1.4051246
Published Online: June 25, 2021
View Article titled, VEMERS UC: A Clinically Validated Emergency Mechanical Ventilator for COVID-19 and Postpandemic Use in Low Resource Communities
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Topics: Biomedicine, Calibration, Circuits, Emergencies, Flow (Dynamics), Oxygen, Pandemics, Pressure, Reliability, Safety
Journal Articles

The Design and Development of an Eye Drop Aid for Glaucoma Patients

Janyut Srihirun, Prayuth Poowaruttanawiwit
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Technical Briefs
J. Med. Devices. June 2021, 15(2): 024504.
Paper No: MED-20-1184
https://doi.org/10.1115/1.4050765
Published Online: April 23, 2021
View Article titled, The Design and Development of an Eye Drop Aid for Glaucoma Patients
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Topics: Design, Safety, Testing
Journal Articles

Avoiding the Alveolar Nerve Via a Real-Time Impedance Analysis: A Novel Method to Improve Implant Surgery Safety

Georg Schiffers, Julian Arnold, Alexander Bartella, Petri Mähönen, Bernd Lethaus
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. June 2020, 14(2): 021003.
Paper No: MED-19-1146
https://doi.org/10.1115/1.4046212
Published Online: February 18, 2020
View Article titled, Avoiding the Alveolar Nerve Via a Real-Time Impedance Analysis: A Novel Method to Improve Implant Surgery Safety
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Topics: Drills (Tools), Surgery, Safety, Drilling, Canals, Bone, X-rays
Journal Articles

Functional Requirements and Quality Assurance Necessary for Successful Incorporation of Electroporation-Based Therapies Into Clinical Practice

Eva Pirc, Matej Reberšek, Damijan Miklavčič
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Expert View
J. Med. Devices. March 2020, 14(1): 014701.
Paper No: MED-19-1150
https://doi.org/10.1115/1.4045837
Published Online: January 31, 2020
View Article titled, Functional Requirements and Quality Assurance Necessary for Successful Incorporation of Electroporation-Based Therapies Into Clinical Practice
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Topics: Electroporation, Patient treatment, Biomedicine, Quality control, Electrodes, Safety
Journal Articles

Percutaneous Ultrasound Gastrostomy: A Novel Device and Bedside Procedure for Gastrostomy Tube Insertion Using Magnetic and Ultrasound Guidance

R. Gentry Wilkerson, Aliaksei Pustavoitau, Howard Carolan, Nolan Benner, Clark Fischer, Daniel J. Sheets, Peggy I. Wang, Steven Tropello
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Technical Briefs
J. Med. Devices. June 2019, 13(2): 024501.
Paper No: MED-18-1123
https://doi.org/10.1115/1.4042866
Published Online: March 6, 2019
View Article titled, Percutaneous Ultrasound Gastrostomy: A Novel Device and Bedside Procedure for Gastrostomy Tube Insertion Using Magnetic and Ultrasound Guidance
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Topics: Biomedicine, Magnets, Safety, Testing, Ultrasound, Biological tissues, Skin, Visualization, Design, Errors
Journal Articles

Adapted Motor-Assisted Elliptical for Rehabilitation of Children With Physical Disabilities

Judith M. Burnfield, Thad W. Buster, Chase M. Pfeifer, Sonya L. Irons, Guilherme M. Cesar, Carl A. Nelson
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. March 2019, 13(1): 011006.
Paper No: MED-18-1027
https://doi.org/10.1115/1.4041588
Published Online: December 4, 2018
View Article titled, Adapted Motor-Assisted Elliptical for Rehabilitation of Children With Physical Disabilities
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Topics: Engines, Motors, Pediatrics, Feedback, Patient treatment, Safety
Journal Articles

Numerical and Experimental Simulations of the Wireless Energy Transmission and Harvesting by a Camera Pill

Elizabeth Shumbayawonda, Ali A. Salifu, Constantina Lekakou, John P. Cosmas
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. June 2018, 12(2): 021002.
Paper No: MED-17-1211
https://doi.org/10.1115/1.4039390
Published Online: March 19, 2018
View Article titled, Numerical and Experimental Simulations of the Wireless Energy Transmission and Harvesting by a Camera Pill
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Topics: Computer simulation, Duck (Textile), Electromagnetic radiation, Phantoms, Safety, Simulation, Skin, Cavities, Energy harvesting, Gelatin
Journal Articles

Surface and Thermal Characteristics of Single-Use Electrosurgical Pencils After Clinical Reuse and In-Hospital Reprocessing

Francesco Tessarolo, Sebastian Torres, Luis Miguel Ballesteros, Marta Rigoni, Federico Piccoli, Iole Caola, Patrizio Caciagli, Yesid Montoya, Giandomenico Nollo
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. December 2017, 11(4): 041010.
Paper No: MED-17-1037
https://doi.org/10.1115/1.4038145
Published Online: October 20, 2017
View Article titled, Surface and Thermal Characteristics of Single-Use Electrosurgical Pencils After Clinical Reuse and In-Hospital Reprocessing
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Topics: Cables, Coating processes, Coatings, Cycles, Differential scanning calorimetry, Expandable polystyrene, Polymers, Safety, Scanning electron microscopy, Temperature
Journal Articles

Review of Kinematics for Minimally Invasive Surgery and Tele-Echography Robots

L. Nouaille, M. A. Laribi, C. A. Nelson, S. Zeghloul, G. Poisson
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Review Articles
J. Med. Devices. December 2017, 11(4): 040802.
Paper No: MED-16-1343
https://doi.org/10.1115/1.4037053
Published Online: October 20, 2017
View Article titled, Review of Kinematics for Minimally Invasive Surgery and Tele-Echography Robots
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Topics: Robots, Biomedicine, Kinematics, Safety, Design
Journal Articles

Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases

Gumei Liu, Eric Chen, Debra Lewis, Gayatri Rao
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Expert View
J. Med. Devices. September 2017, 11(3): 034701.
Paper No: MED-16-1350
https://doi.org/10.1115/1.4036333
Published Online: June 27, 2017
View Article titled, Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases
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Topics: Diseases, Drugs, Food and Drug Administration, Food products, Safety, Medical devices
Journal Articles

Special Issue: Cardiovascular Device Development and Safety Assessment Using Computational Modeling and Experimental Approaches

Marc Horner
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Guest Editorial
J. Med. Devices. June 2017, 11(2): 020301.
Paper No: MED-17-1206
https://doi.org/10.1115/1.4036591
Published Online: May 3, 2017
View Article titled, Special Issue: Cardiovascular Device Development and Safety Assessment Using Computational Modeling and Experimental Approaches
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Topics: Cardiovascular devices, Computer simulation, Experimental methods, Safety
Journal Articles

Novel Solutions Applied in Transseptal Puncture: A Systematic Review

Pedro Morais, João L. Vilaça, Joris Ector, Jan D'hooge, João Manuel R. S. Tavares
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Review Articles
J. Med. Devices. March 2017, 11(1): 010801.
Paper No: MED-16-1224
https://doi.org/10.1115/1.4035374
Published Online: January 24, 2017
View Article titled, Novel Solutions Applied in Transseptal Puncture: A Systematic Review
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Topics: Anatomy, Catheters, Failure, Needles, Radiation (Physics), Safety, Surgical tools, Imaging
Journal Articles

A Force Measurement System for Training of Arthroscopic Tissue Manipulation Skills on Cadaveric Specimen

T. Horeman, G. J. M. Tuijthof, P. B. Wulms, G. M. M. J. Kerkhoffs, R. M. Gerards, M. Karahan
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Technical Briefs
J. Med. Devices. December 2016, 10(4): 044508.
Paper No: MED-16-1011
https://doi.org/10.1115/1.4034145
Published Online: September 12, 2016
View Article titled, A Force Measurement System for Training of Arthroscopic Tissue Manipulation Skills on Cadaveric Specimen
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Topics: Arthroscopy, Biological tissues, Calibration, Computer software, Design, Force measurement, Inspection, Instrumentation, Knee, Navigation
Journal Articles

Primary Amoebic Meningoencephalitis Preventive Nose Plugs: Prophylaxis Against Naegleria fowleri

Abdul Mannan Baig
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Technical Briefs
J. Med. Devices. March 2016, 10(1): 014501.
Paper No: MED-15-1214
https://doi.org/10.1115/1.4032106
Published Online: January 6, 2016
View Article titled, Primary Amoebic Meningoencephalitis Preventive Nose Plugs: Prophylaxis Against Naegleria fowleri
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Topics: Design, Diseases, Silicones, Sports, Water, Medical devices, Performance, Safety