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  1. Science and Research (Medical Devices)

Catalog of Regulatory Science Tools to Help Assess New Medical Devices

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Scientist holding test tube - Catalog of Regulatory Science Tools

This catalog collates a variety of regulatory science tools that the FDA's Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Labs (OSEL) developed and plans to expand as new tools become available.

These tools expand the scope of innovative science-based approaches to help improve the development and assessment of emerging medical technologies. We have provided references for each tool. These tools do not replace FDA-recognized standards or qualified medical device development tools (MDDTs). The FDA has not evaluated the suitability of these tools within any specific context of use.

An essential role of the Office of Science and Engineering Labs is to use the most innovative science to speed medical device development and patient access to safe and effective medical devices by producing tools to help in the assessment of new medical devices.

For more information about the Catalog of Regulatory Science Tools, email OSEL_CDRH@fda.hhs.gov


Types of tools:


Phantoms

Phantom Name Description Type Areas Reference
Nanostructured Virus-simulating Phantoms for Evaluating Optical Biosensing Methods A shelf-stable, biohazard-free viral particle phantom for evaluation of optical biosensing methods Physical Medical imaging and diagnostics Article
Photoacoustic Imaging Phantoms for Assessing Image Quality and Oximetry Performance A set of breast-mimicking phantoms and associated performance test methods for evaluating photoacoustic imaging devices Physical Medical imaging and diagnostics Article
Article
Article
Retina Phantom for Optical Coherence Tomography (OCT) Medical Devices A retina phantom for evaluation of OCT imaging systems Physical Medical imaging and diagnostics Article
Tissue-Mimicking Material for Acoustic Preclinical Performance Characterization of High Intensity Therapeutic Ultrasound Devices Nonclinical assessment model for formulation and characteristics of a hydrogel-based tissue mimicking material (TMM) Physical Therapeutic ultrasound Article
Blood Mimicking Fluid for High Intensity Focused Ultrasound A blood mimicking fluid (BMF) for the acoustic and thermal characterizations of high intensity focused ultrasound (HIFU) ablation devices Physical Therapeutic ultrasound Article
VICTRE:  Multi-modality Anthropomorphic Breast Phantom A digital breast phantom with modifiable parameters including phantom voxel size (resolution) and breast density Virtual Medical imaging and diagnostics GitHub
Document
Phantom for assessing performance of near-infrared hematoma detectors A modular, polymer phantom approach that enables evaluation of the performance of hematoma detectors using wavelengths close to the 805 nm isosbestic point of hemoglobin Physical Medical imaging and diagnostics Article
3D printed phantom material and design with tissue-relevant Raman signature A tool for performing Raman spectroscopy measurements on a well-characterized 3D printed sample that has tissue-simulating optical properties Physical Medical imaging and diagnostics Article
Digital models of retinal vasculature based on a clinical fundus camera image 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 Physical Medical imaging and diagnostics Article
Article
Assembly
Parchment breast phantom A physical breast phantom fabricated from inkjet printing onto parchment paper that can be pendant, compressed, or contain masses Physical Evaluation of 3D breast imaging systems Article
Microcalcification templates Templates containing clusters of microcalcifications that can be inserted into physical breast phantoms Physical Evaluation of 3D breast imaging systems Article

Methods

Method Name Description Type Areas Reference
Flexural Stiffness of Medical Textiles Method for determining the flexural stiffness of medical textiles like surgical mesh Lab Method Materials performance Article
Article
Evaluation of One-way Valves for use in Medical Devices Evaluation of One-way Valves for use in Medical Devices Lab Method Microbiology and infection control Article
Ethylene oxide and polymeric materials: Medical device considerations for material selection Solvent or thermal extraction of ethylene oxide from polymeric materials: Medical device considerations Lab Method Microbiology and infection control
Biocompatibility and toxicology
Article

A tissue-equivalent model to assess role of endothelial cells in the generation of proinflammatory MGCs at device implant sites

The method recapitulates in vivo innate immune responses to biomaterials and wear particles. Lab Method Biocompatibility and toxicology Article
Tool for assessing respiratory adverse effects to medical devices Nonclinical Assessment Model (NAM) for evaluation of substances in contact with respiratory tissues Lab Method Biocompatibility and toxicology Article
Ex vivo porcine indwelling device contamination model Preclinical evaluation of antimicrobial devices Lab Method Microbiology and infection control Article
Fluorescence microscopy protocol for detecting bacteria on devices Reliable detection of bacterial contamination on reprocessed medical devices Lab Method Microbiology and infection control Article
ECG Artifacts for Algorithm Testing A method to estimate device-specific noise from ECG records for algorithm testing Lab Method

Cardiovascular
Patient monitoring and control

Article
Rapid Detection of Bacterial Endotoxins in Ophthalmic Viscosurgical Device Materials A Mass Spec method for evaluation of endotoxin contamination in medical device materials Lab Method Biocompatibility and toxicology
Microbiology and infection control
Ophthalmology
Article
Automated Rapid Accelerated Aging (Automated RAA) An in vitro test platform for expedite durability testing of neural implants Lab Method Biocompatibility/toxicology
Neurology
Article
Modified Dot-Blot Method to Evaluate PPEs An improved and faster method for viral challenge testing of PPE materials Lab Method Microbiology and infection control Article
Article
Article
Genotoxicity Assessment of Nanomaterials A revised genotoxicity test battery for NanoMaterials (NMs) and recommendations to avoid interference Lab Method Biocompatibility/toxicology
Nanotechnology
Article
Reactive Accelerated Aging (RAA)  A simple and robust platform for comprehensive study of the reliability of neural implants  Lab Method Biocompatibility/toxicology
Neurology
Article
Screening of Contaminants in Glycerol-based Medical Products A rapid and simplified method for the detection and quantification of Jatropha-derived phorbol esters (PE) toxins  Lab Method Biocompatibility/toxicology Article
Frictional Test Method to Detect Likelihood of Coating Abrasion in Guidewires A test method for demonstration of coating integrity and durability during abrasion testing and evaluating bench coating performance Lab Method Materials performance Article
Flow Phantom Fabrication Using Inkjet (Polyjet) Additive Manufacturing A lab method for fabrication of flow phantoms using common additive manufacturing approach Lab Method Additive manufacturing Article
Targeted Box and Blocks Test (tBBT) A performance-based method requiring controlled grasping, transport, and release of objects that can be used to evaluate upper limb functional ability. Clinical Outcome Assessment  Orthopedics
Neurology
Article
One-hour Screening of Adulterated Heparin One-hour Screening of Adulterated Heparin by Simplified Peroxide Digestion and Fast RPIP-LC-MS(2) Lab Method Biocompatibility/toxicology Article
Imaging underneath a transparent stimulation electrode A method for real-time optical study of electrical stimulation dosimetry on tissue for safety
 
Lab Method Neurology
Orthopedics
Ophthalmology
Article
Quantitative evaluation of endoscope geometric distortion A mathematically easy to understand and experimentally simple method to quantitatively and objectively evaluate endoscope geometric distortion Lab Method Medical imaging and diagnostics Article
Measurement of endoscope field of view A method that can measure the traditional cone-shaped field of view of all endoscopes Lab Method Medical imaging and diagnostics Article
Assessing texture reproduction of camera-phone-based medical devices A method to assess texture reproduction of camera-phone-based medical devices with a dead leaves target Lab Method Medical imaging and diagnostics Article
Laboratory accuracy evaluation of infrared thermographs Best practices for standardized performance testing of infrared thermographs intended for fever screening Lab Method Medical imaging and diagnostics Article
Wireless coexistence evaluation in the 5 GHz band with LTE-LAA signals Method to evaluate wireless-enabled medical devices in the 5 GHz band for coexistence with LTE-LAA systems Lab Method Electromagnetic & electrical safety Article
Estimating the likelihood of medical device wireless coexistence using logistic regression 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 Lab Method Electromagnetic & electrical safety Article
Method for addressing Bluetooth wireless coexistence Method for addressing wireless coexistence for Bluetooth enabled medical devices Lab Method Electromagnetic & electrical safety Article
Method for addressing Wi-Fi wireless coexistence Method for addressing wireless coexistence for Wi-Fi enabled medical devices Lab Method Electromagnetic & electrical safety Article
Method for analysis of computational model identifiability Method and software code to provide a quantitative measure and graphical analysis of model identifiability (i.e., over parametrization) applicable to multiscale models Lab Method Cardiovascular
Credibility assessment in modeling
Article
Info
Code
Benchmark problems for verifying cardiac electrophysiological models A series of benchmark problems with known exact solutions that can be used to verify if tissue-level (e.g., ventricular, atrial) computational models of cardiac electrophysiology have been implemented correctly Lab Method Cardiovascular
Credibility Assessment in Modeling
Article
easyPEASI: Easy perturbation EEG algorithm for spectral importance A simple method to identify frequency bands of importance in EEG-driven machine learning models 
 
Lab Method Neurology
Artificial intelligence/machine learning
Article
GitHub
Consistency metrics for quantitative electroencephalography Data-driven non-parametric methods to evaluate intra-subject and inter-subject consistency of quantitative EEG biomarkers  Lab Method Neurology Article
GitHub
Confocal Laser Methods (CLM) for quantitative evaluation of dioptric power characteristics of intraocular lens (IOL) implants A series of CLM test methodologies for precise quantitative evaluation of dioptric power characteristics of current and new technology IOL implants Lab Method Ophthalmology Patent
Patent
Dual-confocal laser caliper test method for refractive index and thickness measurements A dual-confocal laser caliper test method for noncontact high-precision sensing and measuring thickness and refractive index of intraocular lens (IOL) implants, thin films and tissue  Lab Method Ophthalmology
Laser therapeutics
Patent
Scanning light scattering profiler (SLSP) method for quantitative evaluation of light scattering A full-angle scanning light scattering profiler (SLSP) test methodology for quantitative evaluation of forward and backward light scattering from intraocular lenses (IOL) implants and other scattering materials and tissue  Lab Method Ophthalmology  
Laser therapeutics
Article
Article
Use of Newtonian Analog Fluids and 3D Printing to Evaluate Flow Rates of Diets in G-Tubes 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 Lab Method Post Market
Signal Response;
Material Performance
Article
Article
Novel In vitro Buckling Test Approach for the Next Generation of Transvenous Cardiac Leads A test method mimicking in vivo physiological service conditions for measuring buckling loads at the distal tip of transvenous pacemaker or defibrillation leads during motion characterized by the cardiac lead's bending or buckling in vivo Lab Method Cardiovascular Article
Considerations for Accelerated Wear Durability Testing for Transcatheter Heart Valves Heart valve leaflet damage patterns can be different based on the deformation of the valve leaflets. Free-edge tearing and commissure tears were the leading cause of valve hydrodynamic incompetence. Mechanical wear after accelerated wear durability testing of heart valve pericardial leaflets affects differently based on whether they are undistorted, stretched, or sagging in a valve configuration Lab Method Cardiovascular Article
Extraction free protein assay Sensitive and specific protein and biofilm quantitation Lab Method Microbiology and infection control Article
Ex vivo porcine skin biofilm model Ex vivo model for testing skin preparation and injection Lab Method Microbiology and infection control Article
Flow cell insert for hydrogel medical devices Test of bacterial interactions with ultrasoft device hydrogels Lab Method Microbiology and infection control Article
Hemoglobin assay for reprocessing Hemoglobin assay for validation and quality control of medical device reprocessing Lab Method Microbiology and infection control Article
High throughput hydrogel biofouling assay Spectroscopic quantitation of hydrogel biofouling Lab Method Microbiology and infection control Article
RP-UPLC Cationic Disinfectants Assay Chromatographic quantitation of polyhexamethylene biguanide (PHMB) antimicrobial agent Lab Method Microbiology and infection control Article
Test soils to evaluate medical devices Clinically relevant test soils to evaluate medical device cleaning/reprocessing Lab Method Microbiology and infection control Article
Article
Article
Article
Article
Medical device interface data sheets A process to determine medical device interface specifications to support safe interoperability Lab Method Electromagnetic and electrical safety
Patient monitoring and control
Article
Article
Article
Monitoring Radiated Coexistence Testing A method for monitoring radiated coexistence testing and estimating the channel utilization of the equipment under test and the source of the unintended signals during testing Lab Method Electromagnetic and electrical safety Article
PESA: Probabilistic Efficient Storage Algorithm for Time-Domain Spectrum Measurements A compression algorithm for time-domain spectrum measurements to facilitate long-term spectrum observation campaigns with a low storage volume requirement as a part of wireless coexistence evaluation Lab Method Electromagnetic and electrical safety Article
Effectiveness of Powder Bed Fusion Residue Removal Protocols A method for assessing the removal of additive manufacturing residues in medical devices fabricated by powder bed fusion Lab Method Additive manufacturing Article
Standard
Assembly
Assembly
Assembly  
Multifunctional method for quantitative evaluation of time-dependent eye hazard from laser pointers A multifunctional test method for quantification of underreported transient fluctuations in critical radiant power characteristics for multiwavelength laser pointers for evaluation of potential eye hazards Lab Method Electromagnetic and electrical safety Article
Battery of image quality test methods for evaluation of fluorescence imaging systems Test methods that provide a practical approach for objective, quantitative evaluation/comparison of fundamental performance in near-infrared fluorescence imagers Lab Method Medical imaging and diagnostics Article
Approach to Validate
Simulation-Based Distributions
A method to validate simulation data using  meaningful agreement metrics which offer a natural way to visually localize regions of disagreement Lab Method Credibility assessment in modeling Article
High Electric-Field Generator
for MRI Safety Testing
A dual-frequency high electric-field generator for Magnetic Resonance Imaging (MRI) safety testing of passive and active implantable medical devices. Lab Method Electromagnetic and electrical safety Article
Article
Transfer Function Measurement Method for Implanted Leads A method to measure the transfer function of leads from active implantable medical devices using the reciprocity theorem for assessment of lead-tip heating during Magnetic Resonance Imaging (MRI) Lab Method Electromagnetic and electrical safety Article
Article
Electrophysiological biomarkers of brain injury Non-clinical biomarkers of brain injury derived from epidermal and epidural electroencephalographs Lab Method Neurology Article
Article
Correction for Hydrophone Spatial Averaging Artifacts for Circular Sources An inverse-filter method to correct for experimental underestimation of pressure due to spatial averaging across a hydrophone sensitive element Lab Method Therapeutic Ultrasound Article
Experimental and computational methods for the acoustic and thermal characterization of therapeutic ultrasound fields A method for simulations and measurements of the high intensity therapeutic ultrasound acoustic field distribution in water and tissue-mimicking material (TMM) and temperature rise in TMM Lab Method Therapeutic Ultrasound Article
Acoustic power calibration of high-intensity focused ultrasound transducers using a radiation force technique A technique for measuring the ultrasonic power from high-intensity focused ultrasound transducers via radiation force, a technique based on pulsed measurements Lab Method Therapeutic Ultrasound Article
Framework for quantitatively estimating ultrasound beam intensities using infrared thermography A technique for measuring intensities of therapeutic ultrasound devices using infrared thermography Lab Method Therapeutic Ultrasound Article
Full-Field Microscale Strain Measurements of a Nitinol Medical Device Using Digital Image Correlation A test method using microscale two-dimensional digital image correlation (DIC) to directly characterize full-field surface strains on sub-millimeter wide medical device coupons under emulated physiological and hyperphysiological loading. The method can be applied to directly validate strain predictions from finite element models of medical devices. Lab Method Materials Performance Cardiovascular Orthopedics Credibility assessment in modeling Article
An in vitro blood flow loop system for evaluating the thrombogenicity of medical devices and biomaterials An in vitro dynamic test method to evaluate device thrombogenicity using a recirculating flow loop system with recalcified ACDA/ heparin anticoagulated donor sheep blood and used within 24–36 hr postdraw. Lab Method Cardiovascular Article
A Reusable, Compliant, Small Volume Blood Reservoir For In Vitro Hemolysis Testing A simple and compliant fluid reservoir appropriate for in-vitro blood trauma testing. Lab Method Cardiovascular Article
Limitations of using synthetic blood clots for measuring in vitro clot capture efficiency of inferior vena cava filters A method to evaluate the clot capture efficiency and capture location in inferior vena cava filters using synthetic polyacrylamide hydrogel clots, which were intended to simulate actual blood clots. Lab Method Cardiovascular Article
Plasma hemoglobin measurement techniques for the in vitro evaluation of blood damage caused by medical devices Method comparison of nine plasma hemoglobin measurement assays for the in vitro evaluation of blood damage caused by medical devices. Lab Method Cardiovascular Article
Quantification by mass of residual debris in reusable medical devices Manufacturers of reusable medical devices perform cleaning validation experiments to ensure that their cleaning instructions are adequate to remove biological material. A filter-weighing method to determine the total mass of insoluble debris using partially-insoluble test soils is proposed. This type of assay may be particularly useful for quantification of particulate test soils that cannot be accurately measured using conventional methods for measuring soluble protein in reusable medical devices. Lab Method Microbiology and infection control Article
Orthopaedic SMART Devices Roadmap An outline for navigating the technological, clinical, cybersecurity, and regulatory challenges associated with smart (instrumented) orthopedic implants. Lab Method Orthopedics Article
Spinal Growing Rod Mechanical Performance Testing Recommendations for conducting preclinical mechanical performance testing on spinal growing rod constructs. Lab Method Orthopedics Article
Integrated Fixation Cage Fatigue Testing Recommendations for evaluating preclinical mechanical fatigue performance of integrated spinal fixation cage devices. Lab Method Orthopedics Article
Article
Considerations for the selection of specimen size for cyclic potentiodynamic polarization corrosion susceptibility testing The size of test specimens used can affect the measured breakdown potential results with larger surface area leading to increased corrosion susceptibility. Lab Method Materials Performance Article
Considerations for the pre-conditioning of specimens for cyclic potentiodynamic polarization corrosion susceptibility testing Surface damage from fretting or fatigue prior to potentiodynamic polarization corrosion susceptibility testing might not affect measured breakdown potential results. Lab Method Materials Performance Article
Article

Computational Models and Simulations

Model or Simulation Name Description Type Areas Reference
Device biokinetic modeling framework Framework to conduct biokinetic models for medical device implants Model Materials performance Biocompatibility and toxicology Article
Article
Flexural Stiffness of Medical Textiles A simple mechanical test method for determining the flexural (i.e. bending) stiffness of medical textiles such as surgical mesh based on cantilever mechanics. Lab Method Materials Performance Article
A high-resolution whole body pediatric numerical simulation model A 29-month-old male whole-body native numerical model, “MARTIN,” including anatomical segmentations to study device - tissue interactions. Model Neurology
Orthopedics
Medical imaging and diagnostics
Ophthalmology
Electromagnetic & electrical safety    

Article
Model

VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation An entirely in-silico imaging clinical trial replicating a premarket study. Model Medical imaging and diagnostics GitHub
Article
VICTRE: Breast Cropping Software A computational tool that crops parts of the breast phantom that are not directly in the path of the x-ray source between compression surfaces Model Medical imaging and diagnostics GitHub
VICTRE: Breast Mass Generation Software A modeling software that randomly generates main body of breast masses including random branching spicules grown out from the mass surface Model Medical imaging and diagnostics GitHub
VICTRE: Model Observers (MO) Computer model observer functions to perform location-known lesion detection tasks Model Medical imaging and diagnostics GitHub
VICTRE: Anthropomorphic Breast Phantom Compression Software A modeling software of physical compression that breasts undergo during mammographic imaging Model Medical imaging and diagnostics GitHub
VICTRE_MCGPU: Pivotal Study Simulations A simulation tool that replicates a Siemens Mammomat Inspiration system for VICTRE Model Medical imaging and diagnostics GitHub
iMRMC: Multi-Reader Multi-Case Reader Studies Statistical tools (java GUI and R package) to analyze, size, and simulate multi-reader multi-case (MRMC) reader studies Model Imaging reader studies, Artificial intelligence/machine learning GitHub
iRoeMetz Application A java application used to simulate reader scores for multi-reader multi-case (MRMC) reader studies Model Imaging reader studies, Artificial intelligence/machine learning GitHub
eeDAP: Evaluation Environment for Digital and Analog Pathology A software and hardware platform for designing and executing digital and analog pathology studies. Model Digital pathology GitHub
Color Scale Study Data Color scale study repository for Cardiac CT and Prostrate MRI Studies Model Artificial intelligence/machine learning GitHub
MIDA: A Multimodal Imaging-Based Detailed Anatomical Model of the Human Head and Neck A tool to generate computational scientific evidence as alternative approaches to clinical Model Neurology
Orthopedics
Medical imaging and diagnostics
Ophthalmology Electromagnetic and electrical safety
Article
Article
CHRIS: Color Hazard and Risk Calculator Rapid (screening level) risk assessments of color additives in medical devices Model Biocompatibility/toxicology Orthopedics Article
High Intensity Therapeutic Ultrasound (HITU) Simulator v2.0 MATLAB-based, user-friendly, and freely available software package for simulating axisymmetric nonlinear pressure fields, computing thermal effects, and validating against experiment Model Therapeutic ultrasound GitHub
Info
CFD/6DOF Model of Clot Transport and Capture in an IVC Filter A computer simulation for prediction of the capture efficiency of IVC filters Model Cardiovascular Article
Article
Kriging Surrogate Modeling for Hemolysis  Computer simulation for estimation and optimization of empirical constants in hemolysis models Model Cardiovascular Article
VICTRE: Digital Mammography Regions of Interest (ROIs) VICTRE ROI patches for digital mammography of breast density categories with microcalcification cluster and spiculated mass inserted signals. Dataset Medical imaging and diagnostics GitHub
Multivariate Physiological Signals During Hemorrhage A set of hemodynamic, cardiovascular and pulmonary variables measurements  Dataset Cardiovascular Article
Benchmark PIV Dataset for Laminar Flow in an Anatomically Realistic IVC Velocity and hemolysis datasets to improve the predictive capability of CFD simulations in the evaluation of medical devices. Dataset Cardiovascular

Article
Article

Interlaboratory Characterization of the Velocity Flow Field in the FDA Blood Pump Model Using Particle Image Velocimetry Experimental datasets for verification, validation, uncertainty quantification, and credibility assessment of CFD simulations in the evaluation of medical devices Dataset Cardiovascular Article
Benchmark Datasets for Validation of Computational Fluid Dynamics Models Experimental datasets of velocity and pressure on simplified medical devices used to validate computational fluid dynamic (CFD) models Dataset Cardiovascular Wiki
The Virtual Family: A set of anatomically correct whole-body computational models The Virtual Family provides detailed three-dimensional computational models of the human anatomy including an adult male, an adult female, and two children Model Neurology
Orthopedics
Medical imaging and diagnostics
Ophthalmology
Electromagnetic & electrical safety
Info
Computational model of the human cardiac action potential Model and software of the human action potential appropriate for simulating arrhythmia initiation in human hearts Model Cardiovascular Article
Code
Computational model of the rabbit cardiac action potential Parsimonious (reduced complexity) model and software of the rabbit action potential amenable to large scale simulations of arrhythmias Model Cardiovascular Article
Code
MC-GPU: GPU-accelerated Monte Carlo simulation of x-ray transport 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. Model Medical imaging and diagnostics GitHub
Mammoreplicator Software tool to create 3D printed phantoms that replicate the attenuation profile observed in real 2D mammograms. The software processes an input mammogram to estimate the amount of x-ray attenuation at each pixel, and outputs a printable triangle mesh object that encodes the observed attenuation map. Model Medical imaging and diagnostics GitHub
MSim3V_IA: design of test objects and tissue substitutes for radiologic applications Software tool to design material combinations that match the x-ray attenuation profile of real tissue, and that can be used as a substitute of biologic tissue in anatomical phantoms for x-ray imaging device evaluation. Model Medical imaging and diagnostics GitHub
Computational Simulation of Clinically Relevant Bioprosthetic Valve Performance Metrics The effects of deformed valve annulus configurations on a surgical bioprosthetic valve were investigated as a model for transcatheter heart valves. Valve leaflet motions, stresses and strains, and analogue hydrodynamic measures (using geometric methods), via finite element modeling. This study adds more evidence for considering the clinical impacts of transcatheter heart valve deformation on acute and long-term valve performance in the design and testing phase of device development Model Cardiovascular Article
Computational modeling comparisons of ASTM F2182 test Technical considerations when using the modeling analog of the ASTM F2182   Model Electromagnetic and electrical safety Article
Estimating local SAR in blood vessels relative to whole-body SAR Methods to compare the local specific absorption rate (SAR) levels in blood vessels in various anatomical regions of a human model and comparisons with ASTM phantom values to extrapolate local SAR of stents to human models Model Electromagnetic and electrical safety Article
HIMSPEC: Pixel-wise spectral transmittance dataset of histological glass slides of human organs The HIMSPEC dataset contains pixel-wise spectral transmittance of human organs tissue microarray slides measured with a hyperspectral imaging microscopy system (HIMS). It provides the reference color truth for evaluating color performance of whole-slide imaging scanners used in digital pathology. Dataset Digital pathology GitHub
Article
o2S2PARC: Open Online Simulations for Stimulating Peripheral Activity to Relieve Conditions An online web-based simulation platform enabling users to create, access, tune, and run predictive, multi-scale, multi-physics models of modulation sources acting on the peripheral nervous system as access points for modulation of organ functional response Model Neurology
Cardiovascular
Electromagnetic and electrical safety
Website
Website
Method of Manufactured Solutions Code Verification of Elastostatic Solid Mechanics Problems in a Commercial Finite Element Solver 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. Model Credibility assessment in modeling Cardiovascular Orthopedics Article
Use of the FDA Nozzle Model to Illustrate Validation Techniques in Computational Fluid Dynamics (CFD) Simulations A "threshold-based" validation approach that provides a well-defined acceptance criterion, which is a function of how close the simulation and experimental results are to the safety threshold, for establishing the model validity. Models Cardiovascular

Article

Verification benchmarks to assess the implementation of computational fluid dynamics based hemolysis prediction models Flow-based verification benchmarks to assess the implementation of commonly cited power-law based hemolysis models in CFD. Models Cardiovascular Article
Fluid-Structure Interaction (FSI) Models of Bioprosthetic Heart Valve Dynamics (BHV) in an Experimental Pulse Duplicator Computer modeling and simulation is a powerful tool for assessing the performance of bioprosthetic heart valves (BHV) when excellent agreement is demonstrated between the computational and experimental results for bulk flow rates, pressures, valve open areas, and the timing of valve opening and closure, and leaflet kinematics in conditions commonly used to assess BHV performance. This work represents a step towards the experimental validation of an FSI modeling platform for evaluating BHVs. Model Cardiovascular Article
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