Catalog of Regulatory Science Tools to Help Assess New Medical Devices
Image
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).
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.
If you are considering using a tool from this catalog in your marketing submissions, note that these tools have not been qualified as Medical Device Development Tools and the FDA has not evaluated the suitability of these tools within any specific context of use. You may request feedback or meetings for medical device submissions as part of the Q-Submission Program.
For more information about the Catalog of Regulatory Science Tools, email OSEL_CDRH@fda.hhs.gov
Regulatory Science Tools Webinar Series
The National Institutes of Health's (NIH) National Heart, Lung, and Blood Institute's (NHLBI’s) Small Business Program partnered with CDRH for a free webinar series examining medical device innovation with regulatory science tools. The webinar recordings are now available:
Types of tools:
- Phantoms (physical and virtual)
- Methods (lab methods and clinical outcome assessments)
- Computational models and simulations (models and datasets)
| 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 | Phantom, 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 | Phantom, 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 | Phantom, 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) | Phantom, 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 | Phantom, 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 | Phantom, 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 | Phantom, 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 | Phantom, 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 | Phantom, 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 | Phantom, Physical | Evaluation of 3D breast imaging systems | Article |
| Microcalcification templates | Templates containing clusters of microcalcifications that can be inserted into physical breast phantoms | Phantom, Physical | Evaluation of 3D breast imaging systems | Article |
| Flexural Stiffness of Medical Textiles | A simple mechanical test method for determining the flexural (that is, bending) stiffness of medical textiles such as surgical mesh based on cantilever mechanics. | 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 |
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 |
| Device biokinetic modeling framework | Framework to conduct biokinetic models for medical device implants | Model | Materials performance Biocompatibility and toxicology | Article 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 |
|
| 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 | |
| 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 | |
| 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 |