Regulatory Science Tools Catalog
![EES](/sites/default/files/styles/card_large_image/public/2024-01/EES.png?h=e0e227b8&itok=CZpaZcNL)
A statistical approach for estimating the likelihood of wireless coexistence of a medical device in its intended environment based on experimental evaluation and realistic environment measurements
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
Method to fabricate realistic microcalcification simulants with adjustable density and sizes, for insertion into phantoms used to evaluate x-ray breast imaging systems
![CM&S Program Image](/sites/default/files/styles/card_large_image/public/2023-12/CM%26S.png?h=86648cd7&itok=kJMvoS7O)
This study demonstrates the application of gold-standard method of manufactured solutions (MMS) code verification to verify a commercial finite element code for elastostatic solid mechanics analyses relevant to medical devices. The Python/SymPy code used to generate source terms is available as supplemental material.
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
A tool to generate computational scientific evidence as alternative approaches to clinical
![Infection Control](/sites/default/files/styles/card_large_image/public/2024-01/Infection%20Control.jpeg?h=3f7bda2c&itok=reY-q1Cn)
An improved and faster method for viral challenge testing of PPE materials
![InterOp](/sites/default/files/styles/card_large_image/public/2024-01/Interoperability.jpeg?h=c404ba51&itok=Q6jICSTk)
A computational modeling tool that provides first-pass estimation of the thermal effect produced in the vaginal wall by vaginal therapy devices.
![Cardiovascualar](/sites/default/files/styles/card_large_image/public/2024-01/Cardiovascular2.jpg?h=38fa3d21&itok=TQicflPH)
Parsimonious (reduced complexity) model and software of the rabbit action potential amenable to large scale simulations of arrhythmias
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
Tool for assessing image quality of advanced nonlinear CT image reconstruction and denoising products, including but not limited to statistical iterative, model-based iterative, and deep learning-based methods
![Orthopaedics](/sites/default/files/styles/card_large_image/public/2024-01/Ortho.png?h=b93ac7c1&itok=gfXlA9BQ)
Lumbar Integrated Fixation Devices-Best Practices for Biomechanical Evaluation Under Fatigue Loading
Recommended best practices for executing in vitro human cadaver fatigue loading and multidirectional flexibility assessment of lumbar integrated fixation device constructs.
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
MC-GPU is a Monte Carlo simulation code that can generate synthetic radiographic images and computed tomography (CT) scans of realistic models of the human anatomy using fast Graphics Processing Unit (GPU) cards.
![Materials Program Image](/sites/default/files/styles/card_large_image/public/2023-12/Materials4.png?h=de93cae1&itok=DKI6GHTv)
This tool provides protocols for conducting preclinical tests recommended in the FDA Guidance for tissue containment systems used during power morcellation procedures.
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
A method to assess texture reproduction of camera-phone-based medical devices with a dead leaves target
![Materials Program Image](/sites/default/files/styles/card_large_image/public/2023-12/Materials4.png?h=de93cae1&itok=DKI6GHTv)
A Method Using 3D Printed Surrogate G-Tubes and Newtonian Analog Fluids to Compare the Flow Rates with Commercial Diets in G-Tubes with the New ISO 80369-3 Connector
![CM&S Program Image](/sites/default/files/styles/card_large_image/public/2023-12/CM%26S.png?h=86648cd7&itok=kJMvoS7O)
A finite element model of the human shoulder for simulating humeral abduction and calculating outputs such as contact force, contact pressure, contact area, stress, and strain.
![Cardiovascualar](/sites/default/files/styles/card_large_image/public/2024-01/Cardiovascular2.jpg?h=38fa3d21&itok=TQicflPH)
An approach for optimal experimental design and estimability analysis for mechanistic models of cardiac electrophysiology to determine their ‘identifiability’
![AI ML](/sites/default/files/styles/card_large_image/public/2024-01/AI-ML.jpg?h=16255f10&itok=Mm7ieYLf)
Statistical tools (java GUI and R package) to analyze, size, and simulate multi-reader multi-case (MRMC) reader studies
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
Best practices for standardized performance testing of infrared thermographs intended for fever screening
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
Digital model available on NIH's 3D Print Exchange site that can be used to fabricate tissue simulating phantoms with biomimetic vascular structures derived from a clinical image
![InterOp](/sites/default/files/styles/card_large_image/public/2024-01/Interoperability.jpeg?h=c404ba51&itok=Q6jICSTk)
A method to estimate device-specific noise from ECG records for algorithm testing
![Neurology](/sites/default/files/styles/card_large_image/public/2024-01/Neuro.jpg?h=43a1839e&itok=gU2A-Yg6)
Non-clinical biomarkers of brain injury derived from epidermal and epidural electroencephalographs
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